Xtalks Life Science Podcast (Xtalks)

In this episode, Ayesha talked about a new at-home blood pressure monitor developed by Inbody that can track blood pressure in real time. The device uses the automated oscillometric method, commonly used in clinical settings now, to generate mean arterial pressure and calculate systolic and diastolic blood pressure from it using an algorithm. The device has a one-touch cuff and can be synced to Inbody’s mobile app, which allows users to access a digital health report outlining their blood pressure readings. This can help identify blood pressure fluctuations that could be indicative of heart conditions. The team discussed the convenience of at-home health monitoring and how it can allow individuals to better manage their health.

The editorial team also discussed Eli Lilly’s nearly $1.5 billion investment into building new manufacturing facilities in the US and Ireland. The pharma giant said the investment will allow the company to expand its manufacturing capacities, particularly in light of new therapeutics it is developing in areas including Alzheimer’s, diabetes, cancer and autoimmune conditions. The pharma giant is anticipating an FDA approval for its Alzheimer’s drug donanemab this year. The new US site will be in North Carolina and the Irish plant will be in Limerick, both home to institutes, universities and companies involved in STEM-based research.

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InBody’s New At-Home Blood Pressure Machine Allows for Real Time Monitoring

Eli Lilly Announces Nearly $1.5 Billion Investment into New Manufacturing Facilities in North Carolina and Ireland

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In this episode, Ayesha discussed the NHS’s recommendation of Libmeldy, a gene therapy for the treatment of the rare disease MLD, which is officially the world’s most expensive drug with a list price of almost $4 million USD. The drug was developed by Orchard Therapeutics and the NHS was able to negotiate a greater discount on it with the company so that it can offer it to patients in England. Libmeldy was initially rejected by the drug price watchdog NICE in England over its exorbitant price. The editorial team discussed the high costs associated with orphan drugs and how both governments and pharma companies must work together to make them accessible to patients. 

The team also talked about a digital risk report that revealed the existence of significant cybersecurity vulnerabilities among the world’s top pharma companies. These include breaches and leakages of items like email addresses, passwords and even credit/banking information. Moreover, a significant percentage of breaches and record exposures occurred after 2020 and worsened in 2021 during the height of COVID-19 vaccine distribution efforts. Widespread cybersecurity breaches can lead to high-level attacks such as ransomware or coordinated disinformation campaigns. The team discussed how cyberattacks could hit almost every aspect of a pharma company’s operations, from R&D through to supply chains, and how this necessitates greater investments in cybersecurity infrastructure.

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UK’s NHS Backs World’s Costliest Drug Libmeldy for the Treatment of Rare Disease MLD

New Report Finds Whopping Increase in Pharma Cybersecurity Threats

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In this episode, Ayesha discussed BioNTech’s new modular mRNA factories, called the BioNTainer, that are destined for Africa to help boost COVID-19 vaccine supplies on the continent. The modular production units are housed in containers that come equipped with raw starting materials and state-of-the-art technology for producing mRNA-based vaccines from start to finish, except for the fill-and-finish step, which will be carried out by local manufacturers. Despite most African leaders welcoming the container factories, there is some controversy over BioNTech’s “paternalistic” control over production of its vaccine, especially since it continues to resist calls for patent waivers for its vaccine.

The team also talked about Eli Lilly’s new COVID-19 monoclonal antibody bebtelovimab that received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) indicated for patients with mild to moderate COVID-19 who are at risk of progressing to severe disease. The treatment replaces Eli Lilly’s previous monoclonal antibody cocktail of bamlanivimab and etesevimab, which was pulled by the FDA over a lack of effectiveness against the Omicron variant. Lilly’s new monoclonal antibody has shown neutralizing activity against Omicron in lab studies so far. The US Department of Human Health Services (HHS) is making it available to patients free of charge. The team discussed how quickly the new monoclonal antibody was developed, showing that companies like Eli Lilly are continuing to work on new iterations of COVID-19 treatments and vaccines in the face of new emerging variants.

 

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BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa

FDA Authorizes Eli Lilly’s Bebtelovimab Which Demonstrates Activity Against Omicron

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In this episode, the editorial team discussed Rare Disease Day which is celebrated every year on February 28 (or February 29 in leap years). This year’s theme was “Share Your Colours,” where individuals with rare diseases were encouraged to share their experiences and aspirations to help raise awareness. The campaign from rarediseaseday.org included a touching video in which patients with rare diseases shared their stories. The editorial team discussed the encouraging growth seen in recent years in rare disease clinical research in the life science industries, providing hope for improved diagnosis, care and treatments for patients with rare diseases.

To mark the end of Black History Month, the team also talked about the underrepresentation of Black people in clinical trials. Although Black people are disproportionately affected by certain diseases due to a combination of socioeconomic and genetic factors, their rates of participation in clinical trials remain concerningly low. In the US, Black people only constitute five percent of all clinical trial participants. Studies show historic medical mistrust among Black people for healthcare systems is the major barrier to trial participation, along with socioeconomic barriers and a lack of patient education. Community outreach and active engagement by the medical and scientific communities are key to improving clinical trial participation among Black people.

This week’s Xtalks Life Science Podcast was sponsored by Elligo Health Research.

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Sharing Colours on Rare Disease Day 2022

Why Black People Remain Underrepresented in Clinical Trials

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In this episode, Ayesha spoke about some of the top women leaders in life science industries in celebration of International Women’s Day. While women remain underrepresented in STEM and life science industries, there are more women in leadership positions at pharmaceutical, biotechnology and medical device companies than ever before. Studies also show that women’s leadership training programs provide effective training for women seeking executive-level positions. The editorial team also shared some of their experiences and insights as women in the life sciences. 

The editorial team also learned about the FDA approval of a new CAR T cell therapy developed by Johnson & Johnson and Legend Biotech for the treatment of relapsed or refractory multiple myeloma. The drug, called Carvykti, is administered as a single infusion and indicated for patients who have not responded to previous treatments. The cell therapy has a list price of almost half a million dollars due to the high development costs of cell therapies, but makers say the clinical benefit they offer is worth the price. Most insurers and Medicare will cover the cost of Carvykti.

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Looking at Women’s Leadership in Life Science Industries on International Women’s Day

Johnson & Johnson’s Carvykti Becomes Second FDA Approved Cell Therapy for Multiple Myeloma

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In this episode, Ayesha talks about new revelations about how Johnson & Johnson funded studies in the early 1970s that involved injecting prisoners in a Pennsylvania jail, most of whom were Black, with asbestos. The company wanted to compare the effects of asbestos versus talc, one of the main ingredients in Johnson & Johnson’s baby powder, on the skin. The company says it regrets backing the human asbestos experiments but says such human testing was common back then. The editorial team discussed Johnson & Johnson’s ongoing legal battles over its baby powder and how it could have better handled the recent revelations by not having made excuses for the asbestos studies.

The editorial team also discussed a new medical imaging device from Swift Medical for digital wound care and other skin conditions. The device fits on top of the camera of a cell phone and uses advanced imaging technology to capture “beneath-the-skin” images of the skin. Swift Medical says the device was designed to make wound care accessible for all patients, regardless of skin type and at any beside or clinical location. The images can be accessed by healthcare providers through an accompanying phone app to allow for remote monitoring and care. The team discussed the significant prevalence of chronic wounds, particularly associated with chronic conditions like diabetes, and how the device offers a great means of accessing information and care right from a cell phone. 

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Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the Past

Swift Medical Reveals New Imaging Device for Remote, Digital Wound Care

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In this episode, Ayesha shed light on National Colorectal Cancer Awareness Month by talking about a new colon cancer screening campaign from Exact Sciences that features a TV ad with Katie Couric. Couric, who is a long-time advocate of colon cancer screening after her husband passed away from colon cancer over 20 years ago, continues her mission to help raise awareness about the importance of early screening for the disease. Exact Sciences’ campaign is appropriately called “Mission to Screen” and includes a TV commercial featuring Couric and her daughter, along with other people that Couric is seen speaking to about their reasons for screening for colon cancer. The ad highlights Exact Sciences’ Cologuard, a DNA-based stool test for colon cancer detection.

The editorial team also learned about Alnylam Pharmaceuticals’ lawsuits against mRNA COVID-19 vaccine makers Pfizer and Moderna over patent infringements. Alnylam claims it invented the lipid nanoparticle delivery technology used in the vaccines and is seeking “fair compensation” for its use. Moderna hit back at Alnylam, accusing it of “blatant opportunism” and saying that it has worked for years on a different version of the RNA delivery technology. The editorial team said it was difficult to take sides in this case without all of the evidence/information, but it isn’t difficult to “believe” Moderna as it has been developing RNA vaccines for over a decade.

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Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology

Exact Sciences and Katie Couric Partner for Colon Cancer Awareness Month with Cologuard TV Ad

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In this episode, Ayesha discussed Pfizer’s voluntary recall of several lots of its blood pressure medication Accuretic and two generic versions of it due to higher than acceptable levels of a carcinogenic nitrosamine compound. The recall affects lots produced between November 2019 and March 2022. The editorial team discussed the increasing frequency of recalls of commonly prescribed drugs like blood pressure and diabetes medications. Should companies and regulators share more information about the steps being taken to address the issue of drug impurities?

The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication. Construction on the facility has commenced and Jazz says it is committed to it being environmentally sustainable at all stages of development and use. Find out how Jazz is going green with its new cannabis-based drug manufacturing facility. 

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Accuretic Blood Pressure Drug and Two Generics Recalled by Pfizer Over Carcinogen Impurities

Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines

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In this episode, Ayesha shared insights she obtained from experts at NIH’s National Heart, Lung and Blood Institute (NHLBI) about clinical trial diversity. The panel of experts outlined some of the challenges in recruiting participants from minority and disadvantaged socioeconomic backgrounds, and talked about an NHLBI initiative based on community outreach that helped recruit more participants from traditionally underrepresented groups for COVID-19 vaccine trials. 

The editorial team also talked about the theme of this year’s World Health Day 2022, which is “our planet, our health.” The theme relates to new WHO data that shows most of the world is breathing polluted air. This is of great significance and concern as environmental causes are a leading cause of death worldwide. Learn about the initiatives and updated guidelines that the WHO has issued to help address the worsening quality of air globally, and hear our team’s thoughts on how environmental responsibilities should be shared.

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Xtalks Voices: NIH Experts Share Insights on Increasing Clinical Trial Diversity

World Health Day 2022: WHO Data Shows 99 Percent of People Breathe Poor Quality Air

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In this episode, Xtalks is marking World Parkinson’s Day (April 11) and Parkinson’s Awareness Month, which are observed every year to help raise awareness about the disease and the individuals living with it. To learn more about new Parkinson’s disease research, Ayesha discussed a new study by researchers at Rush University Medical Center that shows statins may help decrease the risk of parkinsonism in older adults. Hear about how parkinsonism relates to Parkinson’s disease and how the neuroprotective effects of statins could prevent Parkinson’s and related conditions.

The editorial team also discussed a new rapid molecular test developed by UK-based Genedrive PLC that can help physicians select the best antibiotic to treat babies with to prevent hearing loss. Gentamicin is the preferred treatment for newborns with infections like sepsis but about one in 500 babies have a genetic variant that makes them susceptible to gentamicin-induced hearing loss. Find out how the new genetic test can produce results in less than half an hour to help clinicians quickly determine the best course of treatment, and its rollout across a couple of NICUs in England.

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Parkinson’s Awareness Month: Statins May Lower Parkinsonism Risk in Older Adults 

Genedrive’s Genetic Test Can Prevent Hearing Loss in Babies Through Personalized Treatment 

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In this episode, Ayesha discussed BioNTech’s new collaboration with Matinas BioPharma to explore the company’s lipid nanocrystal (LNC) delivery technology for mRNA vaccines. LNC structures are more stable than the lipid nanoparticle technology used in the current COVID-19 mRNA vaccines. Learn about how BioNTech hopes to leverage Matinas’ LNC platform to develop improved mRNA vaccines, including the possibility of orally administered vaccine formulations. 

The editorial team also talked about Pfizer’s acquisition of RSV antiviral therapeutics company ReViral Ltd. in a $525 million deal. Pfizer made the purchase to help expand its RSV portfolio, which currently includes a candidate RSV vaccine that received breakthrough therapy designation from the FDA for the prevention of RSV in individuals 60 years of age and older. With the acquisition, Pfizer is looking to expand its infectious disease portfolio after the great success of its COVID-19 program.

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BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines

Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal

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In this episode, Ayesha talked about World Immunization Week, which is celebrated during the last week of April every year. The theme of this year’s World Immunization Week is “Long Life For All,” which aims to communicate the importance of vaccines for a healthy and fulfilling life by protecting yourself and your loved ones against deadly diseases. Immunization programs were impacted by the COVID-19 pandemic but find out how immunization rates have been on the decline, particularly in developing countries, which have led to the resurgence of diseases like polio and measles.

The editorial team also discussed a new COVID-19 breathalyzer test that recently received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). The mobile rapid test generates results in just three minutes from a sample of exhaled air. Hear more about how the test in the podcast, including how it works and about its high degree of sensitivity and specificity that edges out rapid antigen tests.

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World Immunization Week 2022: Long Life For All

First COVID-19 Breath Test Gets FDA Authorization

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In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. The editorial team discussed the significant unmet need for this condition and how although many women’s health issues are now given greater spotlight, there still need to be more conversations around them. The episode marked World Maternal Mental Health Day and was sponsored by Elligo Health Research.

The editorial team also talked about the latest results of Eli Lilly’s investigational obesity drug tirzepatide, which demonstrated it could reduce body weight by an average of 20 percent in individuals without diabetes. Tirzepatide is a GLP-1 receptor agonist, a class of drugs designed to treat diabetes but at higher doses, can help with weight loss. Hear more about the drug and the obesity drug market, which is projected to grow to $5.42 billion in 2025.

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Oteseconazole (Vivjoa) Becomes First FDA-Approved Drug for Recurrent Yeast Infection

Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial

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In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The drug is the first to target the pathophysiology of obstructive HCM and may be Bristol Myers’ next blockbuster cardiac drug. Hear more about the company’s looming patent cliff for some of its drugs as well as the company’s risk evaluation program for Camzyos given some of its safety concerns.

Ayesha also talked about a new ovarian cancer blood test developed by researchers at the University of Manchester that may help diagnose the disease quicker and more accurately, especially in younger women. The test includes a newer ovarian cancer biomarker that when used in combination with CA-125, the biomarker currently used to monitor and screen for ovarian cancer in some cases, could improve its diagnostic value. Learn more about the test and about the importance of women’s health advocacy in the early detection of diseases like ovarian cancer.

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Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer

Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug

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In this episode, Ayesha discussed a new study that evaluated a text messaging program designed to improve medication adherence and lifestyle factors among heart attack survivors. While the program did not lead to improvements in medication adherence, it did have a positive impact on lifestyle factors like diet. Hear more about the study and the importance of managing heart attack risk factors like hypertension and diabetes. This is especially relevant on World Hypertension Day (May 17) and May Measurement Month, which bring awareness to the importance of accurately measuring blood pressure.

Ayesha also talked about the FDA’s decision to place stricter restrictions on the use of Janssen/Johnson & Johnson’s COVID-19 vaccine given continuing concerns of the rare but serious side effect of blood clots. Hear about why the FDA revised the vaccine’s authorization, and why the FDA maintains that the vaccine’s benefits outweigh any known or potential risks.

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How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

FDA Puts Further Restrictions on Use of Janssen/Johnson & Johnson COVID-19 Vaccine

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In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP). With the approval, Eli Lilly will be giving Novo Nordisk’s blockbuster diabetes injection Ozempic some tough competition. Hear about the projected sales of Mounjaro, data from studies that led to its approval and its impact from a patient perspective.

Ayesha also talked about the current monkeypox outbreak as clusters of cases continue to be reported in countries in Europe and North America. The US recently reported its first case of monkeypox, and all cases so far are linked to international travel. Learn more about monkeypox and how health authorities are asking people not to panic as most cases are mild and treatable. Also hear about how Britain is offering the smallpox vaccine to healthcare workers to help prevent infection from the monkeypox virus.

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Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

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In this episode, Ayesha and the editorial team spoke with Dr. Samantha Dale Strasser, chief scientific officer and co-founder of biotech start-up Pepper Bio. The company is working to develop therapeutics in the areas of oncology, neurodegenerative disease and inflammatory conditions using a ‘transomics’ drug discovery approach. This involves the integrated analysis of several layers of biological data, including genomic, proteomic, transcriptomic and phosphoproteomic data using novel transomics technologies involving lab methods and AI approaches. Hear more about Pepper Bio as well as Dr. Strasser’s journey from academia to the biotech industry.

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This episode features an interview with Georgia Institute of Technology researcher Dr. Woon-Hong Yeo who has helped lead a team of researchers to develop a novel vascular monitoring system based on a specially designed smart stent. Hear about how the implantable smart stent system offers real-time and continuous monitoring of metrics like blood pressure and blood flow, as well as Dr. Yeo’s personal motivation for creating the vascular monitoring system to help people monitor their cardiac health. Dr. Yeo is a Woodruff Faculty Fellow; Associate Professor in Mechanical Engineering and Biomedical Engineering; and the Director of the Center for Human-Centric Interfaces and Engineering at Georgia Tech.

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In this episode, Ayesha discussed new data shared by Eli Lilly for its weight loss injection tirzepatide. The drug was recently approved (under the brand name Mounjaro) by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The dual GIP/GLP-1 receptor agonist also has weight loss effects and recent analyses presented at the American Diabetes Association’s 82nd Scientific Sessions showed that almost 40 percent of participants lost a quarter of their body weight. Hear more about the newest data and industry predictions for tirzepatide as a rival to Novo Nordisk’s GLP-1 receptor agonist weight loss injection Wegovy.

The editorial team also discussed a new global biosimilars awareness campaign launched by Sandoz, Novartis’ biosimilars and generics drug division. The campaign is called Act4Biosimilars and will focus on improving the acceptability and accessibility to biosimilars, among factors, by 30 percent in over 30 countries by the year 2030. The campaign is aimed at addressing global health inequity and inequality by increasing access to advanced medicines like biosimilars. The team discussed the importance of education around biosimilars to help increase their acceptability and uptake.

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More Positive Data for Eli Lilly’s Diabetes and Weight Loss Injection Tirzepatide

Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

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In this episode, Ayesha and the team talked about the FDA approval of Eli Lilly’s JAK inhibitor Olumiant for the treatment of alopecia areata, also commonly just known as alopecia. The drug has become the first approved systemic treatment for the autoimmune disorder that causes patchy hair loss. Hear about how alopecia has received mainstream recognition because of a recent infamous Hollywood incident and the importance of raising awareness about rare diseases like alopecia.

Ayesha also discussed the FDA approval of Alnylam’s RNAi therapeutic Amvuttra for the treatment of polyneuropathy associated with a rare protein disorder called hereditary transthyretin-mediated (ATTR) amyloidosis. Hear about how the drug is also being evaluated for another type of (ATTR cardiomyopathy) and the other big players in the ATTR space including Pfizer and AstraZeneca.

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Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

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In this episode, Ayesha discussed a new collaboration between leading medical technology company Becton Dickinson (BD) and CerTest Biotec who will work together to develop a molecular diagnostic test for the detection of the monkeypox virus. Learn about how BD will leverage its BD MAX platform to develop and validate CerTest’s under development monkeypox test amid an anticipated growing demand for testing given increasing cases of monkeypox infection around the world.

Ayesha also talked about the US Food and Drug Administration (FDA)’s amended authorizations for Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines to include children as young as six months old. The authorizations were based on the FDA’s analysis of efficacy and safety data in pediatric populations. Hear about the vaccine trials and parents’ attitudes towards vaccinating younger children.

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Monkeypox Test Kit in Development by Becton Dickinson in Partnership with CerTest Biotec

FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children Under Five After Unanimous Advisory Panel Support

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In this episode, Ayesha talked about a safety warning issued by the US Food and Drug Administration (FDA) for Secura Bio’s Copiktra (duvelisib), which is a drug used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The FDA flagged the drug after evaluating long-term survival data, which showed that the drug was associated with a higher risk of serious side effects and a possibly increased risk of death. 

Ayesha also talked about a new nuclear magnetic resonance (NMR)-based molecular research tool for the assessment of the risk of Long COVID, including multi-organ damage and cardiovascular disease risk. The phenomics tool is being developed by Bruker for research purposes and is based on well-characterized metabolic and proteomic biomarkers associated with Long COVID. Hear more about the tool and how it can help patients receive appropriate treatment interventions early for Long COVID.

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Copiktra Blood Cancer Drug Gets FDA Warning Due to Increased Risk of Serious Side Effects and Death

Bruker Develops New Tool for Assessing Long COVID Risk

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In this episode, Ayesha discussed the FDA authorization of Novavax’s COVID-19 vaccine, making it the fourth authorized/approved COVID vaccine in the US. It is also the first protein-based COVID-19 vaccine to be authorized in the country. While the vaccine offers an alternate option to people who may still be hesitant about mRNA vaccines, hear why some experts think it won’t have much of an impact on those who are choosing to remain unvaccinated. 

Ayesha also talked about the expanded label approval of Horizon Therapeutics’ gout medication Krystexxa to include its co-administration with arthritis and chemotherapy drug methotrexate. The new approved combination is indicated for the treatment of uncontrolled gout, a rare condition in which patients fail to respond to conventional treatments due to problems including drug resistance. Hear more about gout and the rare condition of uncontrolled gout in this episode.

Read the full articles here: 

Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19

Krystexxa Chronic Gout Medication Gets Expanded FDA Approval

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In this episode, the editorial team spoke with the President and CEO of regenerative medicine biotech Sernova Corp Dr. Philip Toleikis to learn more about how the company is developing a ‘functional cure’ for diabetes. The team heard from Dr. Toleikis about Sernova’s proprietary Cell Pouch System that is designed to house therapeutic cells. Dr. Toleikis spoke about the latest clinical trial data for the medical device, and also about the company’s new partnership with Evotec to integrate its insulin-producing cells in the Cell Pouch System.

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In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence.

Ayesha also talked about biopharmaceutical company Incyte’s new vitiligo drug Opzelura that recently received FDA approval for the treatment of nonsegmental vitiligo. The topical medication is the first approved treatment for repigmentation in vitiligo and also the first approved topical JAK inhibitor in the US. Hear more about raising awareness about rare diseases like vitiligo and how it can help foster the development of new treatments. 

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Zonisamide Liquid Form Gets FDA Approved for Epilepsy Treatment

Opzelura Vitiligo Med Wins FDA Approval as First Treatment for Repigmentation

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In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The new test is as sensitive and accurate as PCR tests and faster than lateral flow (rapid antigen) tests. Hear about the innovative new technology underlying the molecular test, and how the test is also being developed for the detection of other viruses. 

Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The approval makes Enhertu the first approved drug for this indication. Find out about the trial data that led to the approval and its effectiveness in HER2-low breast cancer, which is a newer subtype of the cancer.

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Innova Secures Licensing Rights for U of Birmingham’s New COVID-19 Test Technology RTF-EXPAR

AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer

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In this episode, Ayesha discussed the UK’s approval of Moderna’s next generation COVID-19 vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern. Hear more about the bivalent booster shot, including clinical trial data that led to its approval. Also, hear what Moderna officials have to say about the administration schedule of the new shot.

Ayesha also talked about National Immunization Awareness Month, which is marked every August in the US. Health agencies like the FDA and CDC are not only on the regulatory side of vaccines, but are also committed to helping raise awareness about the importance of vaccines among the public. As part of this, the health agencies suggest healthcare providers should 'strongly recommend' vaccines. Vaccine 'catch up' campaigns are also important now since other non-COVID vaccinations, including routine childhood vaccinations, have lagged during the pandemic. 

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 UK Approves First Omicron-Targeting COVID-19 Booster

National Immunization Awareness Month: Vaccines Work and Catching Up

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This episode features an interview with Dr. Asaf Zviran, CEO and co-founder of C2i Genomics, a biotech company focused on improving cancer detection and monitoring using genomics- and AI-based approaches. Hear about the company’s proprietary cancer surveillance technology, how Dr. Zviran’s founded C2i Genomics, including a personal story, and how the company is focused on truly personalizing cancer treatments.

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In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD. Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action.

Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird bio was awarded the approval for its gene therapy Zynteglo (beti-cel), which is a one-time treatment for the rare blood disorder. Hear more about the therapy, some of the setbacks bluebird has had to face on the road to its approval and why the treatment has a steep price tag.

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Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

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In this episode, Ayesha discussed Fitbit’s new lineup of smartwatches that is set to release this fall, including the Sense 2 which has a sensor for the detection of atrial fibrillation (AFib). Fitbit said the Sense 2 is its most advanced health-focused smartwatch to date. The device has a sensor that can identify signs of AFib through the company’s electrocardiogram (ECG) app and photoplethysmography (PPG) algorithm. Hear more about the AFib detection feature as well as the smartwatch’s new Body Response sensor for stress management. 

Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor’s first approval for a pediatric indication, and the first approved liquid form of the drug. The approval addresses an unmeet need in this indication, as treatment options for cGVHD in younger children are limited. Learn more about the approval in this episode of the Xtalks Life Science Podcast.

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Fitbit Sense 2 Smartwatch with AFib Detection to Launch This Fall

Imbruvica Wins Milestone Approval for Children as Young as 1 With Chronic GVHD

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In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients. The drug is administered intravenously every two weeks and in clinical trials, demonstrated significant improvements in lung function as well as reductions in spleen and liver sizes. Hear more about the rare, fatal disease and the new drug approval for it.

Ayesha also talked about Medtronic’s new partnership with former Disney star Jennifer Stone on a new ad campaign for its diabetes tech, including the smart insulin injector InPen. Hear about Jennifer’s story as a type 1 diabetes patient and how the InPen helps patients like her simplify their diabetes management. Through the ad campaign, Medtronic is hoping to increase awareness about advanced diabetes tech like the InPen. The company is also working on new connected tech to integrate its different diabetes device offerings.

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Sanofi’s Enzyme Replacement Therapy Xenpozyme Wins FDA Approval for Rare Disease ASMD

Medtronic’s InPen Gets Backing from Disney Star Jennifer Stone in Diabetes Tech Campaign

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In this episode, Ayesha shared new research about how scientists at the Francis Crick Institute and University College London have found a mechanism of action to explain how air pollution may cause lung cancer in non-smokers. The research findings revealed that people who live in polluted areas have a higher risk of lung cancer, and that particulate matter smaller than 2.5 micrometers (PM2.5) can act on existing genetic mutations to trigger inflammation and the development of cancer. Hear more about the research findings in this episode.

Ayesha also talked about how a woman with a unique ability to smell Parkinson’s disease has helped scientists develop a new test that may aid in the early diagnosis of the condition. The Scottish woman was able to detect something was off with her husband’s body odor more than a decade before he was diagnosed with Parkinson’s disease. Find out more about how researchers leveraged her powerful sense of smell to develop the new test.

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New Research Reveals How Air Pollution May Trigger Lung Cancer

Scientists Develop Test for Parkinson’s Based on Woman’s Ability to Smell the Disease

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In this episode, Ayesha discussed the FDA approval of bluebird bio’s Skysona for slowing the progression of neurologic dysfunction associated with the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in boys four to 17 years of age with early, active CALD. The one-time administered gene therapy has also taken the title of being the world’s most expensive drug at $3 million. Hear more about the treatment and how the high prices of gene therapies can be alarming, but reimbursement programs are designed to pick up the costs.

Ayesha also talked about the emergence of a new COVID-19 variant called BF.7 that the CDC is closely watching. The new strain of the coronavirus is a subvariant of the BA.5 Omicron variant. It appears to be more transmissible than other variants and subvariants and its incidence has doubled in just two weeks according to the latest CDC data. Find out more about BF.7 including how it could drive the new anticipated wave of COVID infections this fall.

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Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive Drug

CDC Expresses Concern Over New COVID-19 Variant BF.7

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In this episode, Ayesha and the editorial team spoke with Pierre Bertrand, CEO of vision care biotech Neurolens, developer of innovative new technology to address digital vision syndrome. The syndrome is caused by extended computer or digital device use that can result in eyestrain as well as neck and shoulder pain. Hear more about the company’s Neurolenses, which are designed to alleviate and even prevent symptoms of digital vision syndrome. Learn about the proprietary technology behind Neurolenses and recent results from clinical studies that show its effectiveness in improving eye function and comfort.

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In this episode, Ayesha and the editorial team spoke with Caroline Hamilton, Clinical Director of Neuromod Devices, a medical technology company that specializes in the design and development of neuromodulation technologies. The company is committed to addressing the clinical needs of underserved patient populations who live with chronic and debilitating conditions globally. Caroline spoke to Xtalks about Neuromod’s proprietary, patented bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of Neuromod's technology is the Lenire device for the treatment of tinnitus, frequently referred to as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide. Hear more about Neuromod’s Lenire device, including clinical and real-world data showing its effectiveness in improving symptoms of tinnitus. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha discussed Elon Musk’s recent revelation that in addition to fasting, he also used Novo Nordisk’s weight loss drug Wegovy to help him get “lean and fit.” In response to a question on Twitter, Musk disclosed that both fasting and Wegovy were his secrets to his recent weight loss. Musk is not affiliated with Novo so his endorsement of the drug came as a surprise, and is also problematic according to some. Hear more about the story in this episode.

The editorial team also learned about the FDA approval of Nevro Corp’s AI-based spinal cord stimulation (SCS) system for the treatment of chronic pain. Nevro says its Senza HFX iQ system is the first and only AI-based SCS system that personalizes care by “learning from patients.” The implantable device delivers neurostimulation via the company’s proprietary high frequency pulse technology that has been evaluated in more than 90,000 patients. 

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Elon Musk Reveals Weight Loss Injection Wegovy Helped Him Get Lean and Fit

Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

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In this episode, Ayesha and the editorial team spoke with prominent cystic fibrosis and rare disease patient leader Gunnar Esiason to learn more about his advocacy work, including his work in clinical trials and developing patient-facing technologies. Gunnar has consulted on clinical trial development, a real-world evidence population health study and a cystic fibrosis-specific mental health and wellness screening tool. He has been the face of fundraising efforts for the Boomer Esiason Foundation, which has raised more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993. He also has a successful blog and has co-hosted and hosted podcasts, with his most recent one called The State of Health with Gunnar Esiason, which has featured sitting US senators, governors and health industry leaders. Hear more about Gunnar’s work and his passion for patient advocacy and improving rare disease clinical research in this episode of the Xtalks Life Science podcast.

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In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US. It is indicated as a fifth line treatment for multiple myeloma patients who have received four or more prior treatments. Find out more about the bispecific antibody and about trials evaluating it in combination with other drugs to potentially move up its treatment line.

Ayesha also talked about the FDA approval of AstraZeneca’s immunotherapy Imjudo for hepatocellular carcinoma (HCC), which is the most common type of liver cancer. The drug is indicated for use in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi in adult patients with unresectable HCC. The new drug combination will be going up against Roche’s combo of Tecentriq and Avastin, which recently became the standard of care for HCC. Despite this, the Imjudo and Imfinzi approval offers another promising treatment option for HCC patients and is the first dual immunotherapy treatment regimen for this indication.

Read the full articles here:

Multiple Myeloma Drug Tecvayli Becomes First FDA-Approved Bispecific T Cell Antibody

AstraZeneca’s Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver Cancer

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In this episode, Ayesha and the editorial team spoke with Peter Sallstig, MD, MBA, Global Head of Product Development Division and Chief Medical Officer (CMO) at Santen Pharmaceuticals, a biotech company focused on leveraging key, innovative technologies to develop solutions for eye-related problems worldwide. Recently, Santen received FDA approval for the company’s OMLONTI eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. In this interview, Dr. Sallstig spoke about OMLONTI, what makes his work and team at Santen so special and the company’s commitment to innovations in eye health. 

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In this episode, Ayesha discussed Novo Nordisk’s Ozempic (semaglutide) shortage, largely attributed to off-label prescribing for weight loss and viral TikTok videos. The GLP-1 agonist is indicated as a type 2 diabetes treatment but has weight loss as a side effect. The shortage could give competitor Eli Lilly’s new dual GIP/GLP-1 agonist Mounjaro added market advantage, but can the company meet the unprecedented demand?

Ayesha also talked about Eli Lilly falling victim to a fake Twitter account that tweeted the company was offering free insulin. The fraudulent account has a blue check, which users can purchase through a $8 per month subscription for the revamped Twitter Blue program introduced by Elon Musk. Lilly clarified the fake message, but the tweet has re-ignited debate about the cost of insulin in the US.

Read the full articles here:

Novo Nordisk’s Ozempic Shortage Spurs Demand for Eli Lilly’s Diabetes Injection Mounjaro

Fraudulent Eli Lilly Twitter Account Announces Free Insulin

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In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made. Tzield is an immunotherapy that was in development for over three decades. Find out more about the drug and how it may be a gamechanger for type 1 diabetes.

Ayesha also talked about the latest positive Phase III trial data that Pfizer recently shared for its maternal RSV vaccine candidate. The data showed that the vaccine led to a significant reduction in the rate of severe medically attended lower respiratory tract illness (MA-LRTI) in newborns, a complication that can result from respiratory syncytial virus (RSV) infection. Hear more about the vaccine trial data, based on which an independent data monitoring committee has recommended that Pfizer file with the FDA for approval.

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Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

Pfizer Shares Positive Phase III Data for Maternal RSV Vaccine Candidate

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In this episode, Ayesha shared news about the FDA approval of the first gene therapy for the rare blood disorder Hemophilia B. The approval was awarded to CSL Behring’s Hemgenix, a single-dose gene therapy that delivers a working copy of the gene that codes for the Factor IX protein that is deficient, or made in insufficient amounts, in patients with Hemophilia B. The therapy is now officially the world’s most expensive drug at $3.5 million per dose. Hear more about the therapy and how the high price tag of the new drug is actually lower than the cost of treating Hemophilia B patients over their lifetimes with current conventional treatment.

Ayesha also talked about World Antimicrobial Resistance (AMR) Awareness Week, which is led by the World Health Organization (WHO) to improve awareness and take measures to combat the global health threat of AMR. The theme of this year’s awareness week was “Preventing AMR Together,” highlighting the need for multi-disciplinary and collective action against AMR. Ayesha spoke to experts from bioMérieux Canada and One Health to learn more about the global efforts against AMR and shared their insights in this episode.

Read the full articles here:

Hemgenix Approved as First Gene Therapy for Hemophilia B

World Antimicrobial Resistance (AMR) Awareness Week: Preventing AMR Together

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In this episode, Ayesha talked about the FDA approval of Ferring Pharmaceuticals’ fecal matter-based therapy Rebyota for the treatment of recurrent C. difficile infections. While fecal matter transplants (FMT) have been a standard of care for recurrent CDIs, despite not having formal approval, Rebyota has become the first FDA approved FMT-based treatment for CDIs. Hear more about the drug and its approval in this episode. 

Ayesha also discussed a new CBD oral capsule being developed by PureTech Health for the treatment of epilepsy and potentially other indications as well. The drug will be going up against Jazz Pharma’s Epidiolex, which was first approved in 2018 for the treatment of seizures associated with rare types of epilepsy. Hear about the advantages of an oral capsule formulation of CBD, including lower costs and not requiring the use of sesame oil.

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FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

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In this week’s Xtalks Life Science podcast episode, Ayesha and the team spoke with the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, and Amylyx’s General Manager of Canada Chris Aiello.

Amylyx is a pharmaceutical company focused on the development of therapies for neurodegenerative diseases. On September 29th this year, Amylyx received FDA approval for its oral, fixed dose medication Relyvrio for the treatment of adults with amyotrophic lateral sclerosis (ALS). A few months earlier, the medication had received conditional approval in Canada, where it is marketed under the brand name Albrioza. To hear more about Relyvrio’s approval, including how the Ice Bucket Challenge for ALS helped in the drug’s development, and Amylyx’s continuing work in neurodegenerative diseases, tune into the episode.

Read more at:

Relyvrio Approved as ALS Treatment by the FDA

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In this episode, Ayesha talked about some of the trends to look out for in the life sciences in 2023. With a handful of significant gene therapy approvals in 2022, the cell and gene therapy space continues to rapidly expand, and hence we can expect more ground-breaking gene therapy approvals in the coming year, particularly for rare diseases. As our world becomes increasingly digitized, this includes greater implementation of digital health in healthcare. What are the roadblocks and potential burdens of digital health, and can healthcare go completely digital? Also hear about the issue of drug shortages and how pharma companies hope to tackle it in 2023. 

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4 Life Sciences Trends for 2023

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Monique Gary, or Dr. Mo, a breast surgical oncologist, researcher, advocate and expert on cancer and healthcare disparities.

Dr. Mo is passionate about developing integrative, holistic and innovative approaches to cancer treatment, prevention and survivorship both locally and throughout the world. She serves on the board of several community organizations and was recognized as a Leading Physicians of the World and Top Breast Surgeon in Pennsylvania for 2017, 2018 and 2019. 

On the show, Dr. Mo spoke about disparities in breast cancer treatment and care. particularly among minorities, including Black women. She shared ways in which patients can advocate for themselves; discussed some of the advancements in breast cancer screening and prevention; improving clinical trial participation; and the importance of strengthening relationships and communication between patient and physician communities. Hear the informative and insightful conversation in this episode.

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In this week’s episode, Ayesha discussed the new Omicron subvariant XBB.1.5, also known as Kraken, which is rapidly circulating in parts of the US. It is the most transmissible variant yet and is highly immune evasive. COVID-19 cases have been on the rise in the country, including significant increases in hospitalizations and deaths. While XBB.1.5 has been found in dozens of other countries now, cases remain low around the world. Hear more about the new subvariant and why scientists are keeping a close eye on it.

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks. It’s the first inhaler that both treats symptoms and the underlying causes of an attack by targeting inflammation of the airways.

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XBB.1.5 Omicron Subvariant Being Closely Watched as Most Transmissible Variant Yet

AstraZeneca’s Airsupra Approved as First-In-Class Combo Asthma Treatment

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Susan Benton, Country Manager at Thea Pharma, an eye care company that focuses on developing innovative eye care treatments to help further the future of ophthalmic treatment.

Thea Pharma recently won FDA approval for its latest eye care product Iyuzeh for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only preservative-free formulation of the medication latanoprost in the US. 

To talk more about the new FDA approval for Iyuzeh and about the great work being done at Thea Pharma, tune in to hear this informative and insightful interview with Susan Benton, who has more than 25 years of global commercial and business development experience in ophthalmic pharmaceuticals, and has been responsible for the launch and commercialization of more than 15 products over the course of her career.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Ayesha talked about Amazon Pharmacy’s new RxPass subscription prescription drug program called RxPass through which Amazon Prime members can purchase generic medications for a flat fee of $5 a month. The program is part of Amazon’s continuing expansion of its healthcare portfolio. Hear more about the program and how it aims to increase accessibility and affordability for customers.   Ayesha also shared who the top 10 pharma TV ad spenders were in 2022. Ad spending is at an all-time high in the US pharma industry, with companies maintaining a general preference for linear TV marketing over digital marketing. Companies that made it to the top 10 ad spend list included Novo Nordisk with its social media sensation diabetes drug Ozempic and AbbVie’s Rinvoq for eczema and arthritis. The top three spots were taken by ads for immunology drugs and the list includes four type 2 diabetes drugs.  Read the full articles here: RxPass, Amazon’s New Prescription Drug Program, Offers Common Meds for a Flat Fee of $5 Top 10 Pharma TV Ad Spenders in 2022 — Anti-Inflammatories and Diabetes Drugs Dominate For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about the launch of Amgen’s Amjevita, the first Humira biosimilar to hit the market. Amjevita received FDA approval in 2016 and after a legal settlement with Humira maker AbbVie, has finally reached market launch. AbbVie has been embroiled in legal battles over accusations of overpatenting and price hiking to block Humira biosimilar competition. Hear more about Amjevita and how 2023 is a big year for Humira biosimilars with over half a dozen more launching this year.

Ayesha also discussed new Alzheimer’s research from Kings College London that could lead to the development of a blood test for the early detection of the disease. The research found that certain biomarkers in the blood of patients with mild cognitive impairment (MCI), which some Alzheimer’s patients develop before being diagnosed with the disease, could predict the onset of Alzheimer’s up to 3.5 years before a clinical diagnosis is made. Learn more about the new research in this episode.

Read the full articles here:

Amgen’s Amjevita Enters Market as First Humira Biosimilar, But at Two Different Price Points

Early Detection of Alzheimer’s Disease: New Research Shows How a Blood Test Could Lead to Earlier Diagnosis

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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Bastiaan Driehuys, Founder and Chief Technology Officer at Polarean Imaging. 

Polarean is a medical imaging company focused on improving the state of lung imaging. The company recently received FDA approval for its drug device combination product, Xenoview. Xenoview is a hyperpolarized contrast agent, prepared from the Xenon 129 Gas Blend, that is indicated for use with MRI to evaluate lung ventilation in adults and pediatric patients 12 years of age and older. 

Tune into the episode to learn more about the FDA approval of Xenoview, including the journey to its approval. Hear about Dr. Driehuys’ extensive research career developing hyperpolarized Xenon 129 as an MRI contrast agent and how that led him to co-found Polarean with the goal of improving the state of lung imaging.

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In this episode, Ayesha talked about the FDA clearance of a new at-home sleep apnea test developed by Belgium-based scale-up Sunrise. The wireless, AI-powered device is placed on a user’s chin, making it non-invasive and easy to use. The test has been clinically validated against traditional polysomnography testing and can help provide an accurate sleep apnea diagnosis. Hear more about the device in this episode.

Ayesha also talked about the teaming up of basketball legend Kareem Abdul-Jabbar and the Bristol Myers Squibb/Pfizer Alliance for a new ad campaign to help raise awareness about atrial fibrillation (AFib). The basketball Hall of Famer was diagnosed with the condition and in a video for the campaign, he describes how he initially dismissed his symptoms. He encourages others to learn from his experience and seek medical attention as soon as any symptoms appear. February is also American Heart Month, which is marked every year to help promote awareness about cardiovascular health. 

Read the full articles here:

Sunrise’s At-Home Sleep Apnea Test Gets FDA Clearance 

‘No Time to Wait’ Ad Campaign from BMS-Pfizer Features Basketball Legend Kareem Abdul-Jabbar for AFib Awareness 

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In this week’s Xtalks Life Science podcast episode, Sarah spoke with Doug Biehn, Chief Commercial Officer at Cala Health, a bioelectronic medicine company that develops wearable neuromodulation therapies.

The company’s lead product, Cala Trio, was approved by the US Food and Drug Administration (FDA) in 2018 for transient relief of hand tremors in adults with essential tremor (ET).

Tune into the episode to learn more about Cala Health’s individualized prescription neuromodulation therapy. Doug discussed the day-to-day struggles of patients with ET and the challenges they face when seeking medication for their condition. Doug also shared the benefits of Cala Trio for the relief of hand tremors and how company is committed to ensuring all patients have access to this life-changing neuromodulation therapy. For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Ayesha talked about the FDA approval of Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy, a leading cause of blindness. The condition is an advanced form of dry age-related macular degeneration (AMD) for which there have been no treatment options up until this recent approval. Hear more about the drug, including some questions about its clinical benefit.

Ayesha also talked about the FDA’s emergency use authorization (EUA) of Lucira Health’s over-the-counter (OTC) combination COVID-19 and flu diagnostic that can be administered at-home. The molecular PCR test is the first at-home combination test that can differentiate and detect the Influenza A, B and SARS-CoV-2 viruses in 30 minutes or less. The editorial team discussed the utility of the test, including settings in which they may be useful in and whether they may even be needed at all.

Read the full articles here:

Apellis’ Syfovre Approved as First Treatment for Geographic Atrophy Despite Uncertain Clinical Benefit

FDA Authorizes First At-Home Combination COVID and Flu Test

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This episode features an interview with Diarmuid Flavin, Chief Operating Officer (COO) of Neuromod, a Dublin-based medical device company specializing in the treatment of tinnitus, a condition known as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide. The company recently received De Novo approval from the FDA for its tinnitus treatment Lenire. Lenire is the first of its kind, non-invasive, bimodal neuromodulation device that stimulates nerves to treat tinnitus. Diarmuid spoke about the approval and how Lenire helps address a significant unmet need in the tinnitus space. Diarmuid brings more than 25 years of global leadership experience in a range of medical device, technology, and pharmaceutical companies to Neuromod, where he assumes responsibility for the company’s strategic operational execution, Regulatory Affairs, Engineering & Technology, Manufacturing Operations and Supply Chain teams. Hear more about Lenire and Neuromod’s continuing work in biomodal neuromodulation technologies. Read more here: Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Howard Look, CEO and co-founder of Tidepool, a non-profit organization that has a range of software tools for people with diabetes and the clinics that serve them. 

Tidepool recently received US Food and Drug Administration (FDA) clearance of Tidepool Loop, an automated insulin dosing app meant for the management of type 1 diabetes in patients who are six years of age and older. Howard spoke about the FDA clearance and discussed how Tidepool Loop addresses an unmet need in the type 1 diabetes space.

Howard shared his story about his personal connection to diabetes and what prompted him to start Tidepool. He discussed his strategy for engaging stakeholders — the patients, health care providers, caregivers and payers — to pave the way for individuals with type 1 diabetes to access Tidepool Loop.

Hear more about Tidepool Loop and Tidepool’s continuing work in the diabetes management space.

Read more here:

Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 Diabetes

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This episode features an interview with Manu Garg, VP, Head of Healthcare Consulting at Definitive Healthcare. Sarah and Manu discussed the transformative role of healthcare commercial intelligence in the industry today, and how machine learning (ML) and artificial intelligence (AI) are changing care delivery for patients. 

As new drug development is increasingly focused on targeted therapies for rare diseases and other indications with limited patient pools, healthcare commercial intelligence can help companies find their target market and help direct resources. Manu explained how both large and small pharmas, biotechs and medtechs can benefit from Definitive Healthcare’s SaaS-based tools.

Manu explained how AI is helping to predict tumor mutations so that cell and gene therapies can be targeted to individual patient’s needs, realizing the true promise of “personalized medicine.” He also discussed why the healthcare sector needs to adopt new ways of using patient-generated device-based health data to bring care to patients when and where they need it.

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In this episode, Xtalks’ senior editorial staff discuss how the pharmaceutical industry has changed – and stayed the same – in the last 2 decades. Sarah talks about the global value of the pharmaceutical industry in 2002 versus today and which companies made the top 3 based on revenue.

Sarah also shared the top-selling drugs in 2002, 2012 and 2022, and how much the industry as a whole has invested in R&D in those years. The team discusses the number of new drugs and biologics approved by the FDA each year, and debates whether the regulator will be able to keep up with growing submission numbers and the expectation of speedy approval decisions. 

The team also talked about the role of Xtalks in knowledge dissemination and facilitating meaningful conversations in the pharma industry through webinars, written content, videos and, of course, this podcast!

To read more, visit Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History. For a closer look at the stats discussed in this episode, check out this infographic.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Wei-Li Shao, President of Omada Health.

Omada Health is a provider of virtual care solutions focused on common chronic conditions, including both type 1 and type 2 diabetes, hypertension and musculoskeletal. As a virtual-first chronic care provider, the company helps members make lasting changes to improve health and reduce care costs for organizations.

Wei-Li is a global executive leader with over 20 years of experience building and leading biopharmaceutical and diagnostic imaging businesses in the United States, New Zealand, China and Taiwan. He joined Omada Health in 2019 following an 18-year career as an executive at Eli Lilly and Company.

Hear more about Omada Health and its commitment to quality virtual care in this episode.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Ayesha talked about new rules that the US Environmental Protection Agency (EPA is proposing for curbing ethylene oxide emissions from sterilization facilities. The agency says the new guidelines would help reduce emissions by 80 percent, which is particularly important for communities that live near sterilization plants and workers who work at them. Ethylene oxide is a known carcinogenic, with long-term exposure to the odorless, colorless gas being associated with cancers including breast cancer and myeloma among others. The gas is used to sterilize medical equipment as well as spices. Hear about the new proposed rules and industry reactions to them. Ayesha and the team also discussed Johnson & Johnson’s latest offer of $8.9 billion to settle the mountain of talc lawsuits it continues to face. The claimants maintain that the company’s talc-based baby powder had high amounts of asbestos contamination, which the company has known about since the 1970s. One plaintiff group has said Johnson & Johnson’s latest offer is not enough and criticized the company’s strategic bankruptcy plans. A US Court of Appeals rejected the plan earlier this month but Johnson & Johnson said it will take its case to Supreme Court. Hear more about the company’s latest settlement offer in this episode. Read the full articles here: EPA Wants Tougher Restrictions on Ethylene Oxide Emissions from Sterilization Facilities Johnson & Johnson Offers $8.9 Billion in Talc Lawsuits But Not Enough Says a Plaintiff Group For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers. The skin cancer evaluation tool, also called DermaSensor*, is a point-and-click device that can provide health care practitioners with a skin evaluation in seconds.  As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians and patients. Prior to joining DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening and monitoring startup. He began his career in business development and commercial strategy roles at Genentech. Hear more about the innovative technology and application of DermaSensor in this episode. And view a video excerpt of the device in action here: https://youtu.be/4-NnRcyOFHc Read more at: Clinical Studies Support DermaSensor’s Skin Cancer Detection Device *FDA submission pending review. DermaSensor is currently not for sale in the United States. References 1. Merry SP, Croghan I, McCormick B, Chatha K, Leffell D. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology Conference, Las Vegas, NV, November 3-5, 2022. 2. Carli P, Nardini P, Crocetti E, De Giorgi V, Giannotti B. Frequency and characteristics of melanomas missed at a pigmented lesion clinic: a registry-based study. Melanoma Res 2004;14(5):403-407. 3. Soyer H, Argenziano G, Zalaudek I, Corona R, Sera F, Talamini R, et al. Three-point checklist of dermoscopy. A new screening method for early detection of melanoma. Dermatology. 2004;208:27-31. 4. Stanganelli I, Serafini M, Bucch L. A cancer-registry-assisted evaluation of the accuracy of digital epiluminescence microscopy associated with clinical examination of pigmented skin lesions. Dermatology. 2000;200(1):11-16. 5. Dinnes J, Deeks JJ, Grainge MJ, et al. Visual inspection for diagnosing cutaneous melanoma in adults. Cochrane Database of Systematic Reviews. 2018;12:CD013194. 6. Data on File, DermaSensor Inc. 7. Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. Poster Presentation, Maui Derm Hawaii Conference, Wailea, HI, January 24-28, 2023. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment of bladder and bowel dysfunction. The team discussed Axonics Therapy and the occurrence of non-drug (medical device) TV ads. Vera and the team also discussed how two companies, Cerner Enviza and John Snow Labs, are teaming up with the FDA to use AI tools to better understand the side effects of drugs. This project is part of the FDA’s Sentinel Initiative to evaluate the effects of medicines on real-world populations. Hear more about how Cerner Enviza and John Snow Labs will use AI to explore the mental health side effects of a commonly prescribed asthma drug, Singulair (montelukast) Read the full articles here: Axonics Touts Non-Drug Incontinence Therapy in TV Ads How Cerner Enviza Will Use AI To Study the Mental Health Side Effects of Montelukast For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. 

Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.

Read about the publications mentioned in this episode here:

Samsung Bioepis’ First US Biosimilar Market Report

A 'Global Reference' Comparator for Biosimilar Development

An Efficient Development Paradigm for Biosimilars

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One

The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety. 

Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS. The treatment, an antisense oligonucleotide developed by Biogen, targets abnormal proteins arising from SOD1 mutations, which are associated with the development of ALS in some patients. Even though these mutations only account for two percent of ALS cases worldwide, the treatment is an important milestone that sets the stage for the development of more ALS therapies.

Read the full articles here:

Arexvy Becomes World’s First RSV Vaccine

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.) during or after the menopausal transition. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life. The team discussed Veozah and the benefits of this drug for women’s health.

Vera and the team also discussed the recent FDA approval of Allergan Aesthetics’ new hyaluronic acid product, SkinVive by Juvéderm, for achieving skin smoothness. SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation. The team discussed the benefits and novelty of the product, as well as their personal opinions of hyaluronic acid products for skincare and the costs of such treatments.  

Read the full articles here:

Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes

SkinVive by Juvéderm: The New Dermal Filler Coming to the US

See the related webinars here:

Hot Flashes, Brain Fog and the Blues: Frontiers in Menopause Treatments

Innovations in Skin Care Ingredients: Beauty from Within, Wellness Throughout

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In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). It’s the first treatment for the rare disease. Hear more about DEB and Vyjuvek in this episode.

Ayesha and the team also discussed the FDA approval of Bausch + Lomb’s first prescription drug for the treatment of dry eye disease. The drug, called Miebo, is also the first treatment that targets tear evaporation, which is a leading cause of dry eye disease. Hear more about the drug and its approval in the show.

Read the full articles here:

Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

Miebo Approved as First Dry Eye Disease Treatment to Target Tear Evaporation

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In this episode, Vera interviews Carm Huntress, CEO and Founder of Credo Health, about the challenges that the US healthcare industry is facing today with medical record management. Carm discusses why medical records should be digitized and the improvements needed for the retrieval and analysis of digital medical records.

Vera and Carm also discussed how Credo Health’s new AI platform for medical records, PreDX, works and how it makes the tasks of healthcare providers easier. Carm also shared his thoughts about privacy concerns regarding the use of AI to scan medical records. The episode concluded with Carm sharing what’s next for Credo Health.

Read the full article here:

Advancing Medical Record Management: The Power of AI/ChatGPT

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This episode features an interview with Dr. Courtney Silverthorn who is an Associate Vice President at the Foundation for the National Institutes of Health (FNIH) and the Director of the Accelerating Medicines Partnership (AMP) program including the Bespoke Gene Therapy Consortium. 

The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disease clinical trial portfolio.

Hear more about the diseases that were selected and the consortium’s goal of accelerating the path of new therapies for rare diseases to clinical trials.

The Bespoke Gene Therapy Consortium was jointly launched by the NIH and US Food and Drug Administration (FDA) in 2021 to help address common issues that gene therapy developers face. It included formulating a standardized therapeutic development model that would help accelerate clinical trial processes for new treatments.

Read more at: Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

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In this episode, Vera interviews Dr. Grayson Zulauf, CEO and Co-Founder of Resonant Link, about the state of wireless charging for medical device implants today. Dr. Zulauf shares why improvements are needed for faster wireless charging.  

Dr. Zulauf also shared insights into Resonant Link’s latest and the world’s fastest charger for titanium can-based medical device implants. He discussed the impact of this charger on patient care and quality of life. In addition, Vera and Dr. Zulauf discussed the work Resonant Link is doing in other industries, such as electric vehicles and consumer electronics. The episode concluded with Dr. Lulauf sharing what’s next for Resonant Link.

Read the full article here:

Resonant Link Develops Fastest Wireless Charger for Implantable Devices

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This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. 

Hormone replacement therapy (HRT) has been the conventional treatment for menopause-associated vasomotor symptoms, otherwise known as hot flashes and night sweats; however, not all women can receive hormone therapies. Apart from HRT, treatment options have been limited for the vasomotor symptoms of menopause and therefore, the approval of Veozah addresses a significant unmet need in the space. 

Hear more about Veozah, including its mechanism of action and the pathways to its approval.

Read more at: Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes

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In this episode, Vera interviews two experts from CytoMed Therapeutics: Mr. Choo Chee Kong, Chairman and Director; and Dr. Tan Wee Kiat, PhD, Chief Operating Officer.

Established in 2018, CytoMed is a biotechnology firm that originated from the Agency for Science, Technology and Research (A*STAR), Singapore's premier public sector research and development agency. The goal of CytoMed is to develop efficient and cost-effective cellular immunotherapy solutions for solid tumors and hematologic cancers.

On April 14, 2023, CytoMed’s shares began trading on the Nasdaq Capital Market under the ticker symbol "GDTC".

In this episode, Mr. Choo and Dr. Tan share insights about how CytoMed Therapeutics is aiming to engineer more affordable cellular cancer therapies. Dr. Tan discusses the advantages of “off-the-shelf” cell-based cancer immunotherapies. Mr. Choo describes the cellular therapies that are currently in CytoMed’s pipeline. 

The episode concludes with Mr. Choo and Dr. Tan sharing their thoughts about how the company’s initial public offering (IPO) will help them in their mission of developing off-the-shelf cell-based cancer immunotherapies.

Read the full article that mentions CytoMed Therapeutics here:

Biotech IPOs in 2023: Shaping the Future of Innovation

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In this episode, Sarah interviews Dr. Joshua Cohen, Chief Medical Officer at Braeburn, who talks about the stigma associated with opioid use disorder (OUD), and how our treatment of this condition is changing.

Dr. Cohen talks about the recent FDA approval of Brixadi, the first long-acting buprenorphine treatment for opioid use disorder that has both weekly and monthly dosing options, and explains the technology behind its extended-release formula.

Read the full article here:

Brixadi Is a New Long-Acting Buprenorphine Treatment Against OUD 

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Uptake of biosimilars is lagging in the US, but why? In this episode, Sarah interviews Juliana M. Reed, Executive Director of the Biosimilars Forum, to find out the real barriers to widespread access to biosimilars, and how these problems could be addressed.

Julie discusses the role of pharmacy benefit managers (PBMs) and the incentives that keep them from listing most biosimilars on their formularies. She applauds the recent launch of multiple new biosimilars for the blockbuster biologic Humira and explains why this moment is pivotal for the biosimilars industry and the US healthcare system as a whole. 

Mentioned during this episode:

Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis – Xtalks Life Science Podcast Ep. 110

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Jeremy Stackawitz, CEO at Senzo, a London-based MedTech company that has developed a new lateral flow technology for infectious diseases with the same accuracy as central labs testing. Jeremy, who was formerly at companies like Quotient and Johnson & Johnson, discussed how the development of this technology can unlock new models of care such as personalized, preventative and remote healthcare. Senzo’s products and systems bring testing to the patient, allowing for the generation of results that are as accurate as traditional central-lab testing, but faster and at the point-of-care. Senzo says it has started off by targeting diseases with some of the highest global impacts, such as TB, HIV, Flu, Covid, Hep-C and C. diff and plans to move to other viruses and biomarkers. Hear more about how Senzo is working towards its goal to make lab testing accuracy readily available at the point-of-care, real-time, accessible and affordable. Insights generated at the point-of-care will allow patients and healthcare professionals to make better and faster decisions, improving treatment outcomes and saving lives. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. 

Dr. Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children. Dr. Eichenfield was also the principal investigator on clinical trials evaluating YCANTH.

Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases that require medical interventions. 

Tune into this episode to learn more about YCANTH and its approval, as well as the changing landscape of dermatology, from Dr. Eichenfield.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Ayesha talked about the FDA clearance of the world’s smallest insulin pump from Tandem Diabetes Care. The insulin pump, called the Tandem Mobi, features an automated insulin delivery system with options for manual delivery as well. The device is small enough to fit into the coin pocket of a pair of jeans and offers several wearable options. It can be operated through an app and also features technology compatible with continuous glucose monitoring systems. 

Ayesha and the team also discussed the FDA clearance of the first FDA cleared NMR-based test from Numares Health. The company’s AXINON test system measures levels of low density lipoprotein particle (LDL-p), which the company touts as being a more robust biomarker than LDL-cholesterol (LDL-c) for evaluating cardiovascular disease risk. Hear more about the test, including some of its other disease applications, in this episode.  

Read the full articles here:

Tandem Mobi Becomes World’s Smallest Insulin Pump with FDA Clearance

New Cardiac Biomarker Test Gets FDA Clearance

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In this episode, Ayesha talked about the FDA approval of Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). While the approval is a major win in PPD, as current treatments involve administration by infusion or use of general antidepressants, Zurzuvae developers Biogen and Sage Biotech were banking on getting approval for it in major depressive disorder (MDD). However, the FDA rejected it in MDD and only handed the approval in PPD. Hear more about the drug and the approval/rejection in this episode. Ayesha also talked about Johnson & Johnson’s latest bankruptcy attempt related to its talc baby powder cases that was shot down by a US Bankruptcy Court. The company said it will appeal the decision as it continues to offer talc claimants a $8.9 billion settlement, which it says is the best way to resolve the cases in a timely and financially equitable manner. This is the company’s second bankruptcy attempt, both of which have been turned down so far. Listen to the full episode to learn more about Johnson & Johnson’s ongoing legal saga. Read the full articles here: Zurzuvae Earns Win for Postpartum Depression, Faces Challenges in MDDTalc Litigation Saga Continues: Court Rejects J&J’s Latest Bankruptcy Attempt For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. William Williams, CEO of Briacell Therapeutics, a biotech company based in Philadelphia that is dedicated to developing novel immunotherapies to fight cancer and improve patient lives. Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies like Incyte Corporation and GlaxoSmithKline. Dr. Williams has facilitated the entry of over 20 compounds into the clinic, including approvals for ruxolitinib (Jakafi) and baricitinib (Olumiant). BriaCell is developing cell therapies for the treatment of advanced breast cancer and has promising compounds, including Bria-IMT, that are currently being evaluated in clinical trials. BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer. Tune into this episode to hear from Dr. Williams about BriaCell’s novel cell therapies for cancer and what the future of immunotherapy and personalized treatments may look like. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about how three more US states have filed a lawsuit against Eli Lilly over its proposed $13.5 million insulin pricing settlement. The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. The states say the $13.5 million settlement offer from Eli Lilly doesn’t come close to the $1 billion worth of claims the company is facing. Hear more about the insulin pricing controversy in this episode. Ayesha also talked about the FDA approval of Regeneron’s high dose Eylea (HD Eylea) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Hear about how high dose Eylea offers less frequent dosing regiments, and how it will be facing Roche’s blockbuster eye injection Vabysmo. Read the full articles here: More US States Take on Eli Lilly in Court Over Proposed $13.5 Million Insulin Pricing Settlement Regeneron’s High Dose Eylea Gets FDA Nod for Wet AMD and DME For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr. Young discussed with Xtalks in this podcast episode. Dr. Young is Processa’s initial founder, President of R&D and former President and CEO. He has over 30 years of pharmaceutical research, drug development and corporate experience. He served on the Board of Directors and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. He has also served on FDA Advisory Committees and has been a key team member on more than 30 NDA/supplemental NDA approvals. Dr. Young received his Pharm D-PhD with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California. Tune into this episode to hear from Dr. Young about Processa’s developmental pipeline and the promise of personalized, next generation chemotherapies. Learn about Processa’s regulatory science approach to drug development and the changing landscape of cancer treatment. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma, a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s. The drug is the only natural THC-based investigational drug undergoing FDA trials. Ram and Claudia spoke about the compound, including clinical data from the ongoing trials evaluating it. Ram Mukunda is the founder and CEO of IGC Pharma. Previously, he served as Chairman and CEO of Startec Global Communications Corp., Council Member at Harvard Kennedy School of Government and Council Member at Belfer Center for Science & International Affairs. Ram Mukunda has an undergraduate and a graduate degree in biomedical engineering from the University of Maryland. Claudia Grimaldi is currently Vice President, Principal Finance Officer, and Chief Compliance Officer at IGC. She has been with the company for almost 12 years with increasing responsibilities including managing SEC and NYSE filings, regulatory compliance and disclosures. She is also the Managing Director of IGC Pharma Columbia, a director of the company’s subsidiary in India and a director of the board at IGC. Ms. Grimaldi is a psychologist by training, is certified as a public director by the NACD and has an MBA from Meredith College in North Carolina. Tune into this episode to hear from the team at IGC about the company’s commitment to discovering new treatments for Alzheimer’s to help improve the lives of patients and their caregivers. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes. The research, published in Nature Medicine, presents results from a study that evaluated blood-based biomarker tests for the diagnosis of NASH. The study’s co-author, Dr. Tania Kamphaus, Director of Translational Science, Metabolic Disorders, as well as Director of Patient Engagement, at the Foundation for the National Institutes of Health (FNIH), shared results from the study in this podcast episode. She discussed the potential of non-invasive tests to become the standard of care for liver disease diagnosis and the ongoing work her group is doing in this area. Tony Villiotti is the founder of the nonprofit, NASH Knowledge, and a patient whose NASH led to liver cancer and subsequent liver transplant. He spoke about the impact this research will have on the patient community. Tony believes that his liver cancer could have been prevented had a non-invasive test for NASH been available to him. Hear more about Dr. Kamphaus' group’s research in liver disease and Tony’s patient advocacy work to help improve awareness around NASH and help bring new diagnostics and treatments to light. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Vera interviews Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics, about Poseida’s cell therapy approach and technologies. In April 2023, Dr. Yarema became the President of Cell Therapy at Poseida. She brings a wealth of knowledge from the biopharmaceutical realm, with expertise in oncology and allogeneic T-cell immunotherapy. Poseida is a clinical-stage biopharmaceutical firm that utilizes its unique non-viral gene engineering methods to develop innovative cell and gene therapies. With their extensive genetic engineering capabilities, they are paving the way for potentially better and safer treatments for conditions including blood cancers such as multiple myeloma, solid tumors like breast and ovarian cancer, and rare genetic liver diseases. In this episode, Dr. Yarema talks about the advantages of “off the shelf” or allogeneic CAR-T cell therapy vs. autologous cell therapy — and what makes Poseida’s approach unique. Dr. Yarema discusses Poseida’s two Phase I programs in collaboration with Roche, highlighting the strategic partnership's significance for Poseida.

She shares what Poseida is looking forward to with the Investigational New Drug (IND) clearance for the first dual CAR program targeting CD19 and CD20 for the treatment of B-cell malignancies. Dr. Yarema also discusses how the recent $50 million strategic investment from Astellas Pharma in Poseida signifies a notable endorsement and potential growth trajectory for the company. The episode concludes with Dr. Yarema sharing her thoughts about the promise of allogeneic CAR-T cell therapy for patients. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Elmar Joura, Associate Professor of Gynecology in the Department of Obstetrics and Gynecology at the Medical University of Vienna, who spoke to Xtalks about exciting new long-term Gardasil vaccine data from a study he led as principal investigator that showed the long-term impact of HPV vaccination. Merck recently announced new, 10-year long-term follow-up data published in the journal, Pediatrics, for girls and boys who received a three-dose regimen of the HPV vaccine Gardasil 9 at the ages of nine to 15 years old. Immunogenicity data from the study showed sustained HPV-antibody responses ten years after administration of the third dose in both boys and girls. Results also showed no cases of certain HPV-related high-grade disease or certain studied cancers or genital warts. Additionally, no GARDASIL 9-related serious adverse events or deaths were reported. HPV-related cancers and diseases remain a significant public health issue with the CDC estimating that tens of thousands of people were diagnosed with certain HPV-related cancers each year from 2015 to 2019. Hear more about the new long-term HPV vaccine data and the importance of increasing vaccine coverage, particularly in the developing world, in the prevention of HPV-related cancers. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Paul Rennert, co-founder, CEO and CSO of Aleta Biotherapeutics, an immuno-oncology company focused on multi-antigen targeting solutions designed to enhance the action of CAR T cell therapies in B cell lymphoma, B cell leukemia and multiple myeloma, as well as non-B cell cancers such as acute myeloid leukemia (AML) and solid tumors such as breast cancer, gastric cancer and pediatric brain tumors. Dr. Rennert spoke to Xtalks about CAR T cell engagers that Aleta is developing for both B-cell and non-B cell cancers. The company was recently granted clinical trial authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational biologic CAR T-Cell engager ALETA-001. It will be evaluated in a Phase 1/2 clinical trial for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy.  Dr. Paul Rennert is a noted research scientist and biotechnology executive with extensive strategic and leadership experience. After launching successful new biotech companies from 2012 to 2016, he co-founded Aleta Biotherapeutics. Dr. Rennet’s ability to work broadly across the industry grew from his outstanding early career at Repligen and Biogen, highlighted by multiple successful drug-development campaigns, over 50 patents filed and granted, and approximately 100 peer-reviewed publications. Tune into the episode to hear more about Dr. Rennert’s work in advancing CAR T cell therapies in oncology. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about a lawsuit that Johnson & Johnson and IBM are facing over a data breach that occurred at Janssen’s CarePath, Johnson & Johnson’s patient assistance program, the portal for which is run by IBM. The lawsuit was filed with the federal court in the Southern District of New York by a Florida resident who claims the companies failed to adequately protect patients’ personal identity and health information as per the Health Insurance Portability and Accountability Act. Hear more about the data breach and the risk and repercussions of cyberattacks in pharma and healthcare. Ayesha also talked about a new contactless, at home sleep monitoring device that measures vital signs which received clearance from the FDA. The device, developed by Zürich-based med tech startup Sleepiz AG and called Sleepiz One+, offers short- and long-term monitoring of heart rate and respiration during sleep to provide insights into a patient’s physiological status. The company says the device helps monitor disease progression or remission and also helps in the diagnosis of sleep disorders such as sleep apnea. Hear more about the device in this episode. Read the full articles here: Johnson & Johnson and IBM Hit with Class Action Lawsuit Over Patient Data Breach Sleepiz’s At Home Sleep Monitoring Device Wins FDA Clearance For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include hot flashes and night sweats, associated with menopause. Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies. It also included safety data over a period of 52 weeks from three randomized Phase III studies (SKYLIGHT 1, 2 and 4). It is estimated that around 60 to 80 percent of women experience vasomotor symptoms during or after the menopausal transition. They can have a significant impact on daily activities and overall quality of life. Tune into the episode to hear from Dr. Neal-Perry about vasomotor symptoms associated with menopause and the new trial data for fezolinetant. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!" This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Dr. Brown is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary. Prior to joining industry, Dr. Manson Brown was trained to be a Plastic Surgeon and is a board-certified surgeon (MRCS). Dr. Manson Brown spoke about the innovations in the medical aesthetics space, including breast reconstruction for breast cancer patients. She spoke about clinical trials in the space, including Allergan Aesthetics' commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. While FluMist has been in the market since 2003, AstraZeneca is now seeking FDA authorization for a self-administered option of the vaccine. By offering a more accessible and flexible self-administered option, the company and experts in the field hope it will help increase uptake of the flu vaccine, especially as flu vaccinations have been on the decline in recent years. Ayesha and the editorial team also talked about a new ad from GSK Canada that features Wayne Gretzky, as well as a younger, AI-generated Gretzky, raising awareness about RSV vaccination among older adults. The ad features young Gretzky reminding his older self to get his RSV vaccine as older adults are at a greater risk of developing complications from RSV infection. Hear more about the ad featuring the Canadian hockey icon. Read the full articles here: FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration GSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and Old For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP). The company presented details about the trial at the Neuro2023 PSP and CBD International Research Symposium that took place in London last month in October. The ORION study will evaluate the safety, efficacy, and tolerability of AMX0035 in PSP patients. The drug was approved by the FDA last year for the treatment of ALS. PSP is a rare, progressive, adult-onset neurological disorder that affects body movements, walking and balance, eye movement, swallowing, and speech. There are currently no approved medicines to treat PSP. Hear more about the details of the trial, which is set to begin in December this year. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Attorney Temitope (Tope) Leyimu, a toxic exposure attorney at Motley Rice  who is leading a lawsuit over hair relaxing products that contain harmful chemicals.   Hair relaxing products are used for straightening/smoothening hair and many contain harmful formaldehyde, formaldehyde-releasing and other toxic chemicals. The FDA recently issued a recommendation for the recall of chemical hair relaxers containing harmful chemicals. While the agency has initiated its rule-making process, a ban hasn’t been implemented yet.

The products, which have historically been targeted primarily at black and brown women of African descent, have drawn major concern due to their links with reproductive-related cancers such as ovarian, cervical and uterine cancer. An October 2022 study by the National Institutes of Health, revealed that women using chemical straighteners face a 150 percent increased risk of uterine cancer. Attorneys leading the hair relaxer lawsuit including Leyimu say the FDA proposal is a significant step in advancing public health for women, particularly black and brown women, who are disproportionately impacted by many of these products that are alleged to be harmful. Tune into the episode to learn more about the litigation, including the historic racialized marketing of harmful hair relaxing products to women of African descent in the US. If you or anyone you know may have been affected by these products, you can complete the webform to contact Motley Rice if you would like to talk to someone about the lawsuit. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Wa'el Hashad, CEO of Longeveron. Hashad discussed Longeveron’s mission and the therapeutic areas the company is investigating. He discussed the mechanism of action of the company’s lead program, Lomecel-B. Lomecel-B is an “allogeneic” (donor-derived) cell therapy product. Lomecel-B is a cellular therapy currently under clinical investigation as a potential treatment for various aging-related chronic diseases and life-threatening conditions. These studies are conducted under the approval of the FDA’s Investigational New Drug (IND) Applications. Lomecel-B is under clinical investigation for pediatric hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and aging frailty. Longeveron is based in Miami, Florida, with its corporate headquarters and manufacturing operations situated in the Converge Miami Building. Hashad also shared the next steps for Longeveron’s programs. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Fady Boctor, MBA, President and Chief Commercial Officer at Petros Pharmaceuticals, a Men’s Health pharmaceutical company that aims to develop complementary therapeutics designed for a man’s journey. The company focuses on therapeutics that promote medication adherence, tolerability and preservation of male organic function. Fady has over 20 years of experience in the pharmaceutical industry, and has worked for companies such as Novartis, Forest Pharmaceuticals, Auxilium Pharmaceuticals, Endo Pharmaceuticals and Adapt Pharmaceuticals (Emergent Biosolutions). In the episode, Fady discussed Petros Pharma’s lead ED therapeutic and its potential to be transitioned to OTC status. He also discussed the overarching challenges in men’s health today and how Petros is positioned to tackle them. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head. Over the past ten years, Dr. Platt has worked across both infectious disease and vaccines products in both early- and late-stage clinical research. In her current role at Merck, she leads the product development team for V116, an investigational pneumococcal conjugate vaccine. Dr. Platt completed her training in Internal Medicine at Rutgers/Robert Wood Johnson Medical School, and Infectious Diseases Fellowship at New York Presbyterian/Columbia University Medical Center. Dr. Buchwald applies her experience in public health and basic science research to expand Merck’s pneumococcal vaccine franchise and the development of next generation adult and pediatric pneumococcal conjugate vaccines. Since 2017, Dr. Buchwald has focused on pneumococcal disease prevention in various roles at Merck. Dr. Buchwald received her MD and Dr. med degree from the Freie University in Berlin, Germany, and completed her Internal Medicine residency and Infectious Diseases fellowship at New York University. She continues to see patients at Johns Hopkins University. Merck recently announced results from STRIDE-3, a Phase III trial evaluating the immunogenicity, tolerability and safety of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, which is specifically designed for the protection of adults against pneumococcal infection. In this episode, hear more about V116, pneumococcal infection, Merck’s vaccine development program and the company’s approach to addressing the specific needs of different populations, including infants and children, adults and at-risk subgroups. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Adam Kaplin, MD, PhD, Cofounder, President and Chief Scientific Officer at MIRA Pharmaceuticals, a preclinical-stage pharmaceutical company focused on the development and commercialization of new molecular synthetic cannabinoid analogs for the treatment of anxiety and cognitive decline typically associated with early-stage dementia. Dr. Kaplin is a neuropsychiatrist whose research focuses on the investigation of the biological basis of immune-mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin transitioned into industry by joining MIRA Pharmaceuticals to help lead drug development in the space. Prior to joining MIRA Pharmaceuticals, Dr. Kaplin served in a number of positions at Johns Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, among others. He also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways, a company devoted to addiction treatment focused on a combined eHealth and medicine approach. Dr. Kaplin’s original research has been published over 70 times in peer-reviewed publications in key areas in neuroscience and immunology, with a particular focus on the intersection of neurology and psychiatry. In this episode, hear about drug development for conditions like dementia, cognitive decline and anxiety, and how MIRA Pharmaceuticals’ synthetic cannabinoid-based drug candidate could serve as a significant treatment advancement for these conditions. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics, a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. Ben is an engineer by training and prior to joining Monogram, he served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. At Pro-Dex, Ben was responsible for the development, management and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner. Monogram is working to develop tailored orthopedic solutions that can help reduce complications associated with orthopedic procedures such as knee replacement surgery. In this episode, hear about Monogram Orthopedics’ customized implants, which facilitate minimal processing and coordination time for orthopedic joint replacements, and how the company is going up against big industry names like Stryker and its market-leading Mako robot as well as Zimmer Biomet. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about some of the trends in the life sciences to watch out for in 2024. From the increasing integration of artificial intelligence (AI) and machine learning (ML) tools in drug development to medically accurate health wearables, hear about the trends and innovations that will be shaping the life sciences this year. Ayesha spoke to industry experts and innovators in the pharmaceutical, biotechnology and medical device spaces to learn more about these trends and more. Hear about the latest technologies and approaches that will help drive innovations in drug discovery, clinical research and medical device design this year. Read the full article here: Life Science Trends to Look Out for in 2024 For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development. Punit brings two decades of experience as a leader and investor within the life sciences sector. During the interview, he shared his journey leading up to his role at Skye Bioscience and how his previous experiences have shaped his vision for the company. During the interview, Punit discussed Skye Bioscience’s mission and therapeutic approach. The company is aiming to unlock the medicinal possibilities of the endocannabinoid system for addressing diseases that lack adequate treatments for patients globally. At the end of the interview, Punit shared some advice for those looking to venture into the biotech and pharmaceutical industry. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Carlos Doti, MD, Vice President, US Medical Affairs Oncology, AstraZeneca, about new breast cancer treatments. Dr. Doti is a hematologist by training and is passionate about developing treatments that have a real impact for people living with cancer across every aspect of their disease. Dr. Doti has worked in industry for the last 14 years, including seven years at AstraZeneca in various roles, and in small markets like Argentina as well as larger global markets. Since 2022, Dr. Doti has been focusing on the US market in hematology and oncology, working in breast, lung, GI and gynecological cancers among others.

Dr. Doti has previously served in medical affairs roles at Novo Nordisk A/S and Pfizer. His work is supported by more than 70 congress presentations and several peer-reviewed publications. He has also served as an investigator in more than 25 clinical trials in hemostasis, onco-hematology and infectious disease.

Recently, AstraZeneca won approval for the company’s AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). The approval of Truqap was the first-in-class approval for AstraZeneca. Tune into the episode to hear more about the milestone approval of the new combination breast cancer treatment, which has been a much-needed treatment option for the nearly 50 percent of patients with advanced HR-positive breast cancer who have PIK3CA and AKT1 mutations or PTEN alterations, and experience resistance to first-line treatments such as endocrine therapies and CDK 4/6 inhibitors. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, chief financial officer at OncoC4, a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4. OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020. OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications. Dr. Liu is recognized internationally for his research on immune recognition of cancer and activation of lymphocytes. He has received several academic and research awards including the Snyder Award for Cancer Research in 2015, and was elected to the rank of fellow at the American Association for Advancement of Science (AAAS) in 2004 for his pioneering contribution to innate immunity, T cell costimulation and cancer immunology. Prior to serving full-time as OncoC4’s CEO, Dr. Liu was a faculty member at multiple academic institutions, including New York University and the Ohio State University. Abid Ansari is a finance executive with a more 20-year track record in the life sciences industry encompassing corporate finance, fundraising, business development and investor relations experiences for public and private life science companies. Previously, he served as CFO of Artios, a UK-based DNA damage response company where he led the company’s $153 million Series C fundraising. Earlier in his career, Abid held positions at GlaxoSmithKline (GSK) in deal finance and portfolio management. Tune into the episode to hear more about the development of new, cutting-edge cancer treatments, including current challenges in oncology and immunotherapies. Also hear about OncoC4’s collaborations including a co-development commercialization partnership with BioNTech on its lead product and a collaboration with Merck. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured