The Top Line (Fierce Life Sciences)

In this episode of the "The Top Line," Fierce Pharma's Fraiser Kansteiner and Eric Sagonowsky discuss the 20 most influential people in biopharma. We also cover a new topical gene therapy from Krystal Biotech, the FDA approval of Brixadi to treat patients with opioid use disorder, plus more headlines. 

To learn more about the topics in this episode: 

• The most influential people in biopharma in 2023
• FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder
• Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease
• Novo Nordisk pauses Wegovy marketing projects to dampen demand
• It's time for Fierce Biotech's 2023 Fierce 15—nominations are NOW OPEN

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year.

Fierce Pharma Senior Writer Kevin Dunleavy sits down with Cody Powers, a consultant who advises companies on business development and franchise growth strategy, to discuss the reasons behind the numerous high-value deals in 2023, which companies are primed to make major moves this year, and whether the trend of acquiring ADCs and obesity treatments will continue. 

To learn more about the topics in this episode: 

• The top 10 biopharma M&A deals of 2023
• 2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue
• For biopharma M&A, the best returns come from small deals: analysts

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This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry. 

Fraiser Kansteiner of Fierce Pharma engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights. Greffet makes a compelling business case for integrating ESG into the core of drugmakers' DNA. He also discusses Eli Lilly’s specific ESG initiatives, illustrating how these strategies connect to the company’s extensive history. 

To learn more about the topics in this episode: 

• Patient groups want pharma to improve on ESG—and are pushing for a seat at the table
• Setting sights on suppliers: How biopharma is tackling the environment in its ESG commitments
• Seeing green, AstraZeneca lays down £100M for 15-year renewable gas project in UK
• Gilead receives awards, pledges commitment to COVID, the environment and inclusion in 2023

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In this episode of "The Top Line," we talk with Fierce’s Eric Sagonowsky and Kevin Dunleavy about the most expensive drugs in the U.S. We also cover Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• 'Misinformation': AstraZeneca's China head refutes news report about potential spinoff
• Deadline extended: Biopharma's collective memory of COVID—in photographs
• Lilly makes fresh bet on IL-17 with $2.4B acquisition of Dice Therapeutics
• Bristol Myers follows Merck's lead with its own ⁠lawsuit blasting IRA's Medicare negotiations
• Most expensive drugs in the US in 2023

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," join Conor Hale, Senior Editor of Fierce Medtech, and Andrea Park, Deputy Editor of Fierce Life Sciences, as they share the highlights of this year's Fierce Medtech Fierce 15. 

To learn more about the topics in this episode: 

• Fierce Medtech's Fierce 15 of 2023

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On March 29, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner concludes our miniseries to explore what that means for the opioid epidemic. We'll also cover a possible over-the-counter birth control, a COVID test recall, plus this week's headlines. 

To learn more about the topics in this episode: 

• Lilly's hotly anticipated Alzheimer's data set a new high score in slowing cognitive decline
• Baxter breaks off biopharma solutions segment in $4.25B private equity deal
• Let's make a deal: Conditions are right for biopharma M&A to break out, analysts say
• Roche, SD Biosensor recall 500,000 at-home COVID tests due to bacteria risks
• Perrigo's OTC birth control pill aces FDA expert meeting
• Emergent makes history with first FDA nod for over-the-counter naloxone
• Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore peripheral arterial disease, a serious health issue that is often overlooked and undermanaged.  

Join Editor-in-Chief of Fierce Life Sciences and Healthcare Ayla Ellison as she sits down with Kumar Madassery, M.D., Director of the Peripheral Vascular Intervention & CLI Program at Rush University Medical Center. They discuss the hidden dangers of PAD, and Dr. Madassery emphasizes the importance of early detection. He also discusses the launch of the PAD Pulse Alliance, a collaborative effort among vascular health experts aimed at raising awareness, improving early detection and reducing amputation rates. 

To learn more about the topics in this episode: 

• Philips-supported campaign wants Americans to 'get a pulse on PAD' amid ignorance of the disease
• Johnson & Johnson 'Save Legs. Change Lives.' campaign brings PAD amputation awareness to Black community
• Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery

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Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more. 

The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Angus Liu covered the event. 

In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride. 

To learn more about the topics in this episode: 

• Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?
• ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine
• ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy

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Is it all bad news in the bear market? Not necessarily.

After a tumultuous couple of years, many biotechs are looking for signs of improvement in 2023. After all, the biotech sector felt the market pain acutely, particularly over the last 18 months: 2022 marked the longest period of net negative performance for biotech stocks, with the SPDR S&P Biotech ETF XBI extending net losses over a 70-week period. 

But things are looking up: the XBI was 7% up in January of this year, and investor sentiment seems to be improving.

Biotechs can look forward to some upward momentum if they take the right strategic steps now. In this podcast, Sara Michelmore and Karen Sharma from MacDougall Advisors share what biotechs can do to position themselves for this market swing. 

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This episode of "The Top Line" is dedicated to Alzheimer’s disease, exploring the latest treatments and what lies ahead.

In the first segment, Fierce Pharma’s Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. 

Next, Fierce Biotech’s Annalee Armstrong interviews Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They explore the pioneering work being done in Alzheimer's research and discuss the latest breakthroughs. 

In the third segment, Fierce Pharma’s Eric Sagonowsky talks with Reisa Sperling, M.D., who is leading a research team investigating whether Leqembi holds promise in preventing disease progression before any Alzheimer’s symptoms are evident. 

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
• After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
• Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients
• Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
• Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation
• Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline
• Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active

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Pharmaceutical CEOs often earn pay packages worth tens of millions of dollars for leading the top drugmaking companies in the industry. Every year, some new faces enter the rankings while others leave. 

In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss Fierce’s annual special report, “Big Pharma's 10 highest-paid CEOs.” 

Aside from digging into the specific numbers surrounding CEO pay packages, the discussion also touches on CEO-to-worker pay ratios for 2023 and more.  

To learn more about the topics in this episode: 

• Big Pharma's 10 highest-paid CEOs of 2023

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The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck. 

Fierce Pharma’s Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies.

In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners.

To learn more about the topics in this episode:

• 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC field
• ASCO: Gilead looks for silver lining in Trodelvy’s failed lung cancer trial. But will the FDA play ball?
• AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3

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Biogen recently named Christopher Viehbacher its new CEO, ending a monthslong search to replace Michel Vounatsos. Fraiser Kansteiner and Kevin Dunleavy talk about the current state of the company and recent investor reactions to the new hire. Plus, they discuss a string of other biopharma CEO appointments. 

And, in this episode, we cover the week's news including what Albert Bourla, Ph.D., said that has him in hot water along with a $3.5 million drug, and we tease a possible major acquisition. 

To learn more about topics in this episode:

• Biogen's incoming CEO Viehbacher gets mixed reviews—and lots of advice—in investor survey 
• Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line 
• Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal 
• Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths
• Amgen, J&J and Sanofi size up Horizon as Big Pharma renews interest in rare disease M&A 
• Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report 
• GE Healthcare unveils AI program bundle for simplified MRI scans
• Philips unveils AI-powered platform to improve diagnoses from imaging scans

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of the "The Top Line," we talk with Fierce’s Gabrielle Masson and Andrea Park about the most important news coming from this year's annual ASCO meeting. We also cover contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• ASCO: Novocure's tumor-treating electric fields nearly double survival for some lung cancer patients 
• ASCO: Astellas exec jokes that 3 pending drug approvals are turning his hair gray
• ASCO: J&J's multiple myeloma combo produces déjà vu with 96% Carvykti-like response
• ASCO: Illumina's oncology exec on the need to 'democratize genomic profiling in cancer'
• Merck challenges HHS on Medicare drug price negotiations, alleging violations of the Constitution
• Akili launches over-the-counter version of attention-improving video game for adults with ADHD
• FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation.

They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease.

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug

• Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation

• Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline

• Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active

See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," we talk with ViiV’s head of R&D, Dr. Kimberly Smith, about new HIV therapies. We also cover Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• Explore the categories of the Fierce 50
• AstraZeneca stock slides as pivotal lung cancer readout on Daiichi-partnered ADC spooks investors
• Boehringer Ingelheim launches first interchangeable biosimilar to AbbVie's Humira
• Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports
• GSK's ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail. 

To learn more about the topics in this episode: 

• The Fierce 50 of 2023

See omnystudio.com/listener for privacy information.

AstraZeneca has made several news headlines for its environmental sustainability pledges, including deals for renewable natural gas and a commitment to plant hundreds of millions of trees.

In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions.

To learn more about the topics in this episode: 

• Fellowship of the green: AstraZeneca, Samsung, GSK and more unite to slash greenhouse gas emissions

• AstraZeneca sows $400M investment in push to plant 200M trees by 2030

• From farm to pharma: AstraZeneca inks renewable natural gas pact to shrink environmental footprint

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There were a lot of moments in 2022 that left us scratching our heads. In this episode, we’ll recap biotech’s top blunders, boondoggles, gaffes and missteps in our "Rotten Tomatoes" report—plus, we highlight two ripened tomatoes that gave us hope.  

Also in this episode, we cover the week's biggest headlines including drug approvals late in the last stretch of 2022, Moderna's first buy and why Biogen and the FDA are in hot water. 

To learn more about topics in this episode:

• Fierce Biotech's Rotten Tomatoes of 2022
• Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma
• After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca
• After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena
• Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report
• Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M
• Moderna CEO says mpox vaccine is 'fantastic.' It may never see the market
• GE HealthCare completes spinout into 'more focused, more agile' standalone company
• We're looking for the fiercest companies for Fierce Medtech's 2022 Fierce 15
• Fierce JPM Week

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," we talk with Dr Reanne Moore, an associate professor of psychiatry at the University of California San Diego, about the state of digital phenotyping. We also cover the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• Nominations for Fierce Biotech's 2023 Fierce 15 close Friday—three more days to submit
• The Future of Biotech
• ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events
• Tandem crosses FDA finish line with nod for miniaturized insulin pump
• Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report
• Novartis retreats from TIGIT, handing $300M candidate back to BeiGene
• Illumina receives record €432M fine from EU for false start on Grail deal

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

2022 was a tough year for biotechs in anyone’s book. At Fierce, we recorded 119 companies that resorted to laying off staff. And judging by the Fierce Biotech Layoff Tracker, 2023 is looking like more of the same. Fierce Biotech’s James Waldron sat down with Glenn Hunzinger, the U.S. pharma and life science leader at PwC, to talk about the financial trends he expects biotechs to face in 2023. 

Plus, in this episode, we cover Emergent's Narcan over-the-counter approval, the first PTSD neuromodulation device approval and more of this week's top headlines. 

To learn more about the topics in this episode: 

• We have achieved peak biotech formation. It's time for 'musical chairs'
• 'Stay alive': Wave of layoffs crashes into biotech startup inferno
• Fierce Biotech Layoff Tracker 2023: Alector sends home 11%; Ferring closes US research institute
• Fierce Biotech Fundraising Tracker '23: OncoVerity tacks on $30M from argenx, Univ. of Colorado; Sonoma nabs $30M Regeneron investment
• Fierce Biotech Layoff Tracker: Layoffs strike 119 companies in 2022
• Fierce Biotech Fundraising Tracker: Enlaza launches with $61M; Enveda brings in $68M
• Emergent makes history with first FDA nod for over-the-counter naloxone
• Neuromodulation device for PTSD treatment from GrayMatters snags FDA nod
• Musk's Neuralink seeks a clinical trial partner as it awaits FDA go-ahead: Reuters
• J&J scraps late-stage RSV vaccine in R&D overhaul, dropping out of race with GSK, Pfizer
• Look out, Lilly. Novartis touts 'consistent benefit' for Kisqali in broad early-stage breast cancer
• From cell therapies to US-made ingredients, White House outlines new drug manufacturing goals

The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Just last year, congress passed the Inflation Reduction Act. The law contains several drug pricing measures hated by the pharmaceutical industry, including restrictions to price increases and Medicare negotiations. Eric Sagnowsky talked with Stacie Dusetzina, a professor at Vanderbilt University's Department of Health Policy, about what we can expect. 

Also on the show, Fierce's Analee Armstrong and Gabrielle Mason reflect on the biotech industry last year and our expectation for 2023—plus, this week's headlines. 

To learn more about topics in this episode:

• 2023 forecast: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation'
• 2023 forecast: Biotech plummeted from 'the highest of highs' in 2022. Will the sun shine again next year?
• Fierce Biotech Fundraising Tracker: Enlaza launches with $61M; Enveda brings in $68M
• Fierce Biotech Layoff Tracker: Layoffs strike 119 companies in 2022
• Theranos' Elizabeth Holmes labeled a 'flight risk' as she asks to delay prison sentence during appeal
• Eli Lilly shut out of Alzheimer's fast lane with FDA rejection for donanemab
• Health group lambasts CBS ‘60 Minutes’ segment for overt promotion of Novo Nordisk’s obesity med Wegovy
• Eli Lilly to pour $450M more into diabetes drug plant in North Carolina, add 100 jobs
• Frosty funding forecast forces Finch to stop phase 3 trial, lay off 95% of staff and seek buyers for assets

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Learn how Slope’s eClinical Supply Chain Management platform provides robust technology to the clinical trial space, covering all areas of supply management without losing sight of the chain of custody.

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We totaled the salaries, stock options and bonuses awarded to various medtech CEOs to figure out who the highest paid chiefs were. And our top 10 list saw a few ups and downs over the past year. We'll hear from Connor Hale and Andrea Park as they discuss medtech's highest paid CEOs.

Also in this episode, we cover the week's biggest headlines including Theranos' COO's jail sentence, highlights from the American Society of Hematology annual meeting, and an update on the Horizon Therapudics bidding war. 

To learn more about topics in this episode:

• Fierce JPM Week 
• The top 10 highest-paid medtech CEOs
• Fierce Biotech's ASH 2022 Coverage
• Fierce Pharma's ASH 2022 Coverage
• Theranos' Sunny Balwani lands 13-year fraud sentence after ex-partner Elizabeth Holmes gets 11 years
• Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati 
• FDA advisers nix Cytokinetics' heart failure med, rejecting argument for subgroup use 
• Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war 
• Sanofi started—and lost—$28B bidding war for Horizon. Is the company's M&A appetite still rumbling? 
• AstraZeneca, Biogen, Daiichi, Lundbeck, UCB all hit with drug marketing breaches, but highest censure reserved for Novo Nordisk

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," Zoey Becker talks with Dr. Andrew Norden, Chief Medical Officer at OncoHealth, about the ongoing chemotherapy shortage sweeping the nation and what oncologists and health insurance companies can do to best support patients amidst these supply chain issues.

We also cover the a single-injection treatment for sickle cell disease, battery-powered gene therapy, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them
• FDA to allow temporary overseas production to shore up supplies of chemo drug
• FDA can't solve drug shortages on its own, agency's oncology chief says
• FDA links 4 deaths to recalled Abiomed Impella pumps after TAVR collisions
• Quest launches blood test for Alzheimer's disease aimed at general consumers
• One injection to cure sickle cell? Researchers give it a shot with new mRNA gene therapy
• With 3 AA batteries and 2 acupuncture needles, a device controls gene expression in live mice
  

"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Should physicians consider the psychological status of patients more when developing and delivering treatment plans? What knowledge barriers are there to this? And how can these barriers be overcome?

These questions lie at the heart of what John Kane has been pursuing as a healthcare communications and education expert for more than 30 years.

As Managing Director of MedThink Communications, having run his own agency for 17 years, he works with the simple mission to "turn information into outcomes."

In this episode of The Top Line podcast, John explores the link between a proper understanding of psychological factors and likely success of treatments. The conversation then moves on to discussing some of the key challenges faced by the medical industry in leveling the playing field between biological and psychological knowledge. Effective education and communication, he says, are a fundamental part of any solution.

Want to hear more from John? Listen to the podcast today.

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In this episode, Dr. Beate Mueller-Tiemann, Chief Technology Officer at Cytiva, joins Fierce Life Sciences’s Stephanie Butler.

Having spent almost all of her career working within large pharmaceutical enterprises such as Sanofi and Bayer, Beate made the switch to Cytiva in the early part 2023.

Her role at Cytiva involves overseeing teams which create and bring high-quality products and innovative manufacturing and R&D processes closer to patients. Beate also keenly supports female talents through participation in mentoring programs. Additionally, she is a member of FiDAR, an association which seeks to increase the representation of women on German corporate boards.

During the conversation, Beate discusses her passion for technology and how her career has been defined by working with technology to bring innovation and treatments to patients and improve health outcomes. She also touches on the ongoing work Cytiva is engaged in, as well as the importance of collaboration in driving R&D progress.

Tune in to the podcast to learn more. Check out this year's Fierce 50 honorees: https://fierce50.fiercelifesciences.com/

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This week on "The Top Line," we'll share highlights from the Cell & Gene Therapy Forum. Lack of access and multimillion-dollar costs have stirred debate over the appropriate price of potentially lifesaving cell and gene therapies. Fierce’s Max Bayer spoke with a panel of stakeholders at the forum. They discussed the state of play for cell and gene therapies and how they can become a genuine game changer for the many, not the few. We also talk with executives from Poseida Therapeutics and AviadoBio. 

To learn more about topics in this episode:

• Zolgensma for dementia? AviadoBio gains orphan tag for one-dose gene therapy 
• Poseida taps former Novartis VP as president of gene therapy 
• Fierce Biotech Summit: Disruptive gene technology is here—and society seems willing to pay for it
• Fierce Biotech Cell & Gene Forum

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

The antifungal agent Amphotericin B is highly effective against a wide range of deadly fungi and resistance is rare, even after decades of use. But it comes with a virtual guarantee of kidney damage, earning it the nickname “Ampho-terrible.”   

Now, a better alternative might be on the way. Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., a chemistry professor and researcher at the University of Illinois and the founder of antifungal startup Sfunga Therapeutics, to get the story behind the new drug’s design, its path to the clinic and how it could influence the next generation of antimicrobials.

To learn more about the topics in this episode: 

• Potent new drug has all the power of nature's strongest antibiotic, without the toxicity

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While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.

In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more. 

To learn more about the topics in this episode: 

• Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
• 'The Top Line': Leqembi's full approval and the future of Alzheimer's treatment
• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

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This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. 

In this episode, Fierce Pharma’s Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines.

They also dive into past hurdles in the space and highlight the varied approaches—including their own—that a new generation of cell and gene therapy manufacturing companies have been pioneering. 

To learn more about the topics in this episode: 

• Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test

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The FDA is making some changes in the accelerated approval process. In this episode, we’ll discuss the recent changes with the FDA’s regulation of cancer drugs and how these shifts will impact the biopharma industry.  

Also in this episode, we cover the week's biggest headlines from the annual J.P. Morgan Healthcare conference. 

To learn more about topics in this episode:

• Fierce JPM Week
• Podnosis: The Pulse of the Healthcare Industry
• FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
• Capitalizing on share price crash, AstraZeneca inks $1.8B CinCor takeover for blood pressure drug
• JPM23: Chiesi gets jump-start on JPM buzz with $1.48B Amryt buyout
• JPM23: Ipsen scoops up liver disease specialist Albireo for $952M
• Editas rewrites its own code after tough 2022, sending staff packing and editing down programs
• JPM23: Editas touts skinnier pipeline after major shake-up to ride out 'unfriendly' markets
• With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch
• AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use
• Baxter bids adieu to $5B kidney care division with spinout plan

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her. 

To learn more about the topics in this episode: 

• Biotechs end year 'trading for nothing' as investors mull 'what is IPO-able today?'
• Fierce Biotech Layoff Tracker 2023
• Editor's Corner—When ASCO dueled with the world's biggest pop star, Swift Biotech was ready for it
• Alzheimer's meds are here. But for the Down syndrome community, it's still the 1980s

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While generative AI has dominated the spotlight in the past year, machine learning programs have already been significantly impacting patients and physicians for several years. The question now arises: how will the emergence of programs like ChatGPT, coupled with increasing calls to scrutinize their safety, influence the adoption of new AI programs and diagnostics in healthcare?  

This week on “The Top Line,” Fierce’s Conor Hale interviews Peter Shen, the North American head of digital health at Siemens Healthineers, to explore what developers and regulators can do to ensure transparency in medical AI. He also dives into how the field could potentially benefit from a 21st-century update to the Hippocratic Oath. 

To learn more about the topics in this episode: 

• 2024 forecast: Will generative AI find what it needs to deliver for patients? 
• FDA to form advisory committee for digital health and AI 
• US government to launch AI Safety Institute, develop standards for biotech R&D 
• Biden to sign sweeping executive order pursuing 'safe, secure and trustworthy' AI development 

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In this episode of The Top Line, sponsored by the Parenteral Drug Association (PDA), we explore the upcoming PDA/FDA Joint Regulatory Conference, happening September 9-11 in Washington, D.C.

Our guest, Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna and Co-Chair of the 33rd annual event, shares why this conference is the essential annual CGMP event to attend.

Janeen notes the direct access to federal regulators and the unique insights from FDA colleagues as standout features. The FDA co-sponsored conference is known for fostering collaboration among scientific minds to create practical solutions and best practices, with this year's focus on improving quality culture, shifting to proactive approaches, and evolving quality maturity.

Key sessions will cover de-risking quality control environments by utilizing case studies on OOS and OOT results, and enhancing lab systems with QRM. The conference's focus on Current Good Manufacturing Practices (CGMP) makes it a must attend for quality assurance and operations professionals. Additionally, discussions will delve into the role of AI in manufacturing and data integrity.

For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024.

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In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.

"Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages.

To learn more about the topics in this episode:

• Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith
• Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M

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This week on “The Top Line,” we explore the European biotech investment landscape. 

Fierce Biotech’s James Waldron sits down with Maina Bhaman, a Partner at Sofinnova Capital Strategy, who provides insights into how investors are approaching the European biotech sector. 

To learn more about the topics in this episode: 

• 'The fundamentals are really strong': Why investors are staying loyal to European biotech in 2023
• 'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says Sofinnova chair

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This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing.

In this episode, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree.

The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importance of locking in process decisions early and how to effectively scale projects from the lab to the clinic and eventually to the market. Additionally, they talk about Germfree’s recent asset acquisition from Orgenesis, which will allow the company to expand its mission of decentralized manufacturing.

To learn more about the topics in this episode:

• Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
• With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide
• Catalent opens cell therapy production site at Belgian 'center of excellence'
• After recent troubles, Catalent expands its biologics services platform

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Fierce’s JPM Week event was packed full of informative panels, executive interviews and fireside chats. So for today’s episode, we’ve pulled out a couple of snippets to take you inside the gathering.

First up, listen in on Fraiser Kansteiner’s lively panel discussion on how companies will keep their bottom lines strong while navigating the drug pricing policies that the Biden administration rolled out just last year. You will also hear from Zoey Becker’s interview with Bayer’s Christine Roth. As head of the oncology strategic business unit, Roth talks about the plans to establish Bayer as a strong competitor in the cancer space.

To learn more about topics in this episode:

• 2023 forecast: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation'
• To bolster IRA, lawmaker calls for new action to scrutinize cancer drug launch prices
• Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report
• JPM23: Bayer hikes sales targets for Kerendia, Nubeqa to $3B each
• Look out, Pfizer. With new approval, Bayer's Nubeqa is set to challenge Xtandi's prostate cancer crown
• Bayer's blockbuster hopeful Nubeqa debuts in later-stage prostate cancer in UK under early access program
• Bayer poaches GlaxoSmithKline exec to lead expanding oncology business—including a blockbuster hopeful
• Fierce JPM Week

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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“Essentially, this allows our clinical researchers to improve the chances of success for the trial leading to faster, more efficient drug development… Ultimately, this is going to benefit patients.”

Greg Lever is speaking about the use of flexible modeling to allow real-time changes to be made to clinical trial design and processes. 

As a Director within the IQVIA Applied Data Science Center, and with over a dozen years of experience in the field, Greg knows the importance of data and advanced analytics in generating accurate patient insights to underpin key trial decision-making.

By making clinical trials more patient friendly, he states, the more likely it is that research organizations will be able to attract and retain the participants they need to bring life-saving treatments to patients.

In this podcast, Greg outlines how modeling can be used to enhance the entire patient journey, from the initial giving of informed consent right through to the trial’s close.

Host: Julia Douthart

Producer: Matt Rickman

Sponsored by IQVIA

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Layoffs have hit biopharma hard over the last year and a half. In this episode Fierce's Max Bayer and Gabrielle Mason will discuss the recent trends. We'll also cover a gene therapy by Sarepta Therapeutics, Abbott's FDA approval, plus this week's headlines. 

To learn more about the topics in this episode: 

• Layoffs continue to batter biotech, with Big Pharmas piling on the pain
• Abbott's spinal cord stimulators score FDA approval to treat nonsurgical back pain
• Theranos' Elizabeth Holmes ordered to report to prison amid appeal, fined $452M in restitution alongside Sunny Balwani
• UPDATED: FTC sues to block Amgen's $28B Horizon buy in alarming sign for biopharma M&A
• UPDATED: FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. In the wake of these developments, new biotech companies are springing up spurred by advancements that redefine what conditions might soon become treatable.  

One contender in this rapidly changing landscape is Verve Therapeutics. This week on "The Top Line," Fierce Biotech’s Max Bayer sits down with the company’s CEO Sekar Kathiresan, M.D., to discuss how Verve intends to distinguish itself. They also chat about what drove Dr. Kathiresan to biotech after more than 20 years as a cardiologist and geneticist.  

To learn more about the topics in this episode: 

• Verve Therapeutics unveils its lead program—a one-and-done treatment for genetic high cholesterol
• Lilly beams up Verve gene therapy programs for $600M from deal-hungry Beam
• Verve shows base editing works in humans in first clinical data—and is punished by investors
• Verve's base editing hold lifted, starting a thaw on a regulatory blockade that sent peers ex-US

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While it’s a known fact that women, on average, live longer than men, a recent report unveils a nuanced reality—women also spend more of their lives grappling with poor health. 

This week on “The Top Line,” Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, explores the root causes behind this disparity and the multifacted nature of the women’s health gap. She's joined by one of the lead authors of the report, Valentina Sartori, Ph.D., and a contributor to the report, Kelle Moley, M.D.  

The report highlights that addressing the women’s health gap and investing in women’s health could inject $1 trillion into the economy annually by 2040, and Dr. Sartori explains why that number could be a significant underestimation. 

While the report provides a clear understanding of the challenges, it also sheds light on viable pathways to close the women’s health gap and create a future where women not only live longer but lead healthier lives. 

To learn more about the topics in this episode:  

• Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies
• White House launches new initiative aimed at investing in women's health research
• Organon finally offers a larger pharma model for women's health. But 'one company can't do it by itself'
• CMS unveils new model to support Medicaid agencies in offering whole-person maternal health
• Menopause care is still a largely untapped market. Here's why investors and startups should dive in

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Fierce Biotech regularly pulls together the industry’s top money raisers from the year before. Staff writer Gabrielle Masson and Editor-in-Chief Ayla Ellison discuss a few of the biotechs at the top of the list. 

Plus, in this episode, we cover Johnson & Johnson's talc litigation, prison plans for Elizabeth Holmes and more of this week's top headlines. 

To learn more about the topics in this episode: 

• Biotech's top money raisers of 2022
• Johnson & Johnson's $8.9B bankruptcy settlement is 'unworkable,' talc plaintiff lawyer says
• Theranos' Elizabeth Holmes must report to prison this month despite pending appeal, judge rules
• FDA dubs Abbott's FreeStyle Libre battery issues a Class I recall, spanning 4.2M devices
• Philips re-recalls 1,200 CPAP, BiPAP machines repaired in far-reaching ventilator probe
• Activist investor Icahn calls for Illumina CEO to be voted off company board over Grail deal
• Moderna's mRNA flu shot struggles to prove its worth again in phase 3 trial
• Sanofi's Provention buyout hit with FTC delay. Will Pfizer's Seagen deal go off as planned?
• After last year's cuts, Biogen kicks off another round of layoffs

The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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M&A plummeted in 2022 compared to the previous year. But some medtech companies were still able to pull off multibillion-dollar megadeals. We tracked it all on Fierce Medtech’s list of the 10 biggest M&A moves in 2022. In this episode, we discuss some high points from the roundup. 

To learn more about topics in this episode:

• The top 10 medtech M&A deals of 2022
• Acquisitive Pfizer to strike again? Seagen back in M&A talks after Merck walked away: WSJ
• Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul
• FDA hands first emergency authorization to over-the-counter test for both COVID and flu
• Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio
• BioCryst hits another hurdle, delays trial for its one remaining clinical candidate

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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Dr. Christopher Piorkowski, Divisional Vice President and Chief Medical Officer of Abbott's Electrophysiology business, is the latest guest on The Top Line podcast.
A seasoned expert in the field of electrophysiology, he joins us to discuss and explain some of Abbott’s latest solutions and advancements, as well as best practices to support treatment for abnormal heart rhythms.

EnSite X, for example, is Abbott’s revolutionary 3D heart mapping software which Piorkowski describes as the company's most important product development of the past decade and compares it to the transition from a gasoline to an electric car in terms of its implications.

And it is easy to see why. EnSite X acts as an ultra-accurate GPS system that helps physicians to locate and understand the areas in a patient’s heart needing ablation. A significant update has been the incorporation of near field technology – this helps physicians to understand which of the electrical signals that they see on the catalyst is truly from the location of a catheter, as opposed to signals that come from further away in so-called far field signals. 

The discussion also takes a turn towards pulsed field ablation, something which Abbott has been working with for well over a decade.

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Last August, Moderna filed a lawsuit against Pfizer and its COVID-19 vaccine partner, BioNTech. Moderna claims that the partners copied its mRNA technology and infringed its vaccine patents. Pfizer wasn’t going to sit back and take that. In September, the pharma giant dismissed the claims and accused Moderna of trying to rewrite the pandemic story to place itself in the “single, starring role,” the company’s attorneys wrote in a scathing countersuit.   

Kevin Noonan, Ph.D., is an intellectual property lawyer. He spoke with Fierce Pharma staff writer Zoey Becker to discuss what is likely to be the most significant patent fight from the pandemic era.   

To learn more about topics in this episode:

• Clash of the titans: Moderna sues Pfizer, BioNTech for mRNA patent infringement
• Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit
• Moderna won't enforce COVID-19 vaccine patents during pandemic
• Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit
• NuVasive, Globus Medical ink $3.1B orthopedic device merger, sending investors scrambling
• Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight
• GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo, seek new partners
• Call for nominations: The most influential people in biopharma in 2023

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023. 

To learn more about the topics in this episode: 

• 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
• 2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
• 2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs

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This week on “The Top Line,” we’re speaking with Jared Baeten, MD, Ph.D., Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled individuals to lead longer and healthier lives by taking and staying on medication. Nevertheless, HIV persists as a significant public health challenge. To end the HIV epidemic, it is crucial to go beyond a biomedical approach and fully integrate social determinants of health into the collective response. Not everyone is achieving long-term success. 

Long-term success involves meeting more than the United Nations’ goals of ending the epidemic by 2030. Treatment selection can help prioritize long-term outcomes from the very beginning. There are several other key factors for people with HIV and their healthcare providers to consider when assessing treatment choices, such as the resistance and safety profile of a treatment, drug-to-drug interaction potential, and comorbid conditions.

This podcast is brought to you by Gilead Sciences. Visit gileadhivtogether.com to learn more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.

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Victoria Summers is a principal at ZS and the East Coast lead for the company’s patient health and equity accelerator. She is also used to being on the other side of the mic, hosting the company’s own podcast that focuses on the issue of patient centricity.

Victoria tackles a range of questions and discussion points around the subject of patient engagement and how the industry can and should reach out to the people who rely on their solutions.

How should information be communicated? How does communication and patient outreach tie into the ongoing and pressing challenge of promoting health equity? Will better engagement lead to the creation of more effective solutions? 

These are just some of the discussion points touched on in this episode. Tune in to discover Victoria’s take on these issues, and more. 

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This week on "The Top Line," we discuss 2022’s Fiercest Women in Life Science honorees. Each year, we spotlight women who are leading the way in life sciences—women who stand out as leaders, innovators and mentors. We’ll hear from Andrea Park and Querida Anderson on what it took to make the cut for this year's class of fiercest women in life sciences. Plus, this week's headlines. 

To learn more about topics in this episode:

• 2022's Fiercest Women in Life Sciences
• Eli Lilly issues rare apology as fake Twitter Blue account proclaims free insulin for all
• Eli Lilly pulls Twitter ads after blue check fallout: report
• Roche's anti-amyloid antibody gantenerumab fails phase 3 in major blow to Alzheimer's ambitions
• NFL expands head injury research project using impact-tracking mouthguards, as concussion protocols come under fire
• Mayo Clinic launches digital referee for spotting potential bias in healthcare AI programs
• Four decades in, ImmunoGen gets landmark green light in advanced ovarian cancer
• Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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Last week, senior editor Annalee Armstrong and staff writer Gabrielle Mason covered the Clinical Trials on Alzheimer’s Disease conference. We'll hear from them as they discuss the latest news and what surprised them.  

Also in this episode, we cover the week's biggest headlines including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks.

To learn more about topics in this episode:

• Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal
• Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths
• Roche thins Alzheimer's program after phase 3 failure, may seek 'external partnerships'
• A winner is crowned in head-to-head Alzheimer's battle between Biogen's Aduhelm and Lilly
• Neuralink under federal investigation for animal testing practices: Reuters
• Elon Musk claims Neuralink is 6 months from implanting brain-computer interfaces in humans—and, someday, he'll be one of them
• 'Troubling' study finds Google's kidney disease-predicting AI performs worse in women—and may not have a quick fix
• In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program
• Rigel scores green light in AML just 4 months after buying asset from Forma
• UPDATED: J&J bows out of Horizon bid as Amgen and Sanofi eye cash plays for rare disease drugmaker
• Pfizer plots €1.2B investment—and up to 500 new jobs—at Irish manufacturing plant
• Fierce JPM Week

"The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," Annalee Armstrong and Gabrielle Masson shine a spotlight on some of the most promising companies in the biotech world. Additionally, you'll have the opportunity to hear from Kevin Dunleavy as he engages in a conversation with Ray Pressburger from Accenture, discussing drug commercialization and the models that are proving to be the most effective.

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This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. 

In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera.  

They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies.  

To learn more about the topics in this episode:

• CAR-T hype faces infrastructure reality check
• CAR-T boxed warnings: What comes next?

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In this episode of "The Top Line," Teresa Carey talks with Dr. Sebastian Ocklenburg, Department of Psychology at MSH Medical School Hamburg, Germany, about how significant left-handedness is to clinical research. It is International Left-Hander's Day, so we dive deep into understanding brain hemisphere asymmetry and its significance in the context of neurodevelopmental and psychiatric disorders.

"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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In this podcast interview, Dan Fisher, managing director and practice lead for IPM.ai, a division of Real Chemistry, explains how weekly data from 300 million patients can help brands assess a patient population, accelerate clinical trial recruitment, and optimize commercial outcomes.

Machine learning and artificial intelligence have emerged as key technologies for stitching together medical events and then predicting a diagnosis, even for conditions that are so rare no ICD-10 code exists. Once a de-identified rare or specialty disease patient is uncovered, IPM.ai enables clients to reach their top physicians directly, so they can prescribe a treatment-appropriate therapy or recommend a clinical trial. 

Fisher also discusses how IPM.ai works in cooperation with its sister organization, Swoop, to help reach and activate patient and physician audiences through healthcare advertising and a next best action engagement model, including for rare and specialty disorders.

Ai is an outstanding tool to help advance medical and business aspirations.

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This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. We're diving into our recent spin on March Madness at Fierce.

This time around, Fierce Biotech kicked off its inaugural Best Biotech Name tournament, while over at Fierce Pharma Marketing, we held our biannual Drug Names tournament.

The editors discuss what makes a company or drug name tick, what to steer clear of, and how the entire competition played out. 

To learn more about the topics in this episode: 

• #FierceMadness: AstraZeneca and Ionis cruise to victory as Wainua trounces Lilly's Mounjaro for the tournament win
• #FierceMadness: The Best Biotech Name Tournament—A champion is CROWNED

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What is the transformative potential of digital health technologies in advancing health equity? Rabin Martin, a global health consulting firm, explores those possibilities in this engaging episode.

The conversation highlights the excitement surrounding digital tools and advanced analytics in achieving deeper insights, consistent care delivery, workforce support, and addressing social determinants of health.

Listen in now.

Host: Heath Clendenning, Fierce Life Sciences

Producers: Matt Rickman and Samantha Mazzotta

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This week on "The Top Line," we explore biopharma layoffs in the first quarter of 2024. 

Using data from Fierce Biotech's layoff tracker, Gabrielle Masson and Max Bayer analyze the trends of layoffs in the first quarter of 2024, comparing them to previous years. With a notable number of layoff rounds marking the start of the year, they examine the factors behind this ongoing challenge while also highlighting positive industry developments.

To learn more about the topics in this episode: 

• No reprieve for biopharma layoffs in Q1: Fierce Biotech analysis
• Fierce Biotech Layoff Tracker 2024

See omnystudio.com/listener for privacy information.

This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry.

Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. They also discuss the details of the special report and share some of the stories behind the numbers. 

To learn more about the topics in this episode:  

• Biotech's top money raisers of 2023
• Fierce Biotech Fundraising Tracker 2024
• Fierce Biotech Fundraising Tracker 2023

See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond. 

Fierce Pharma’s Zoey Becker chats with Gregg Sylvester, M.D., Chief Health Officer at CSL Seqirus, to get insight on what we might expect to see from this upcoming flu season. He also explains efforts to increase vaccine uptake through awareness and education campaigns.  

To learn more about the topics in this episode: 

• Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season
• CDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groups
• American Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaign

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This year kicks off the second decade of Fierce Medtech’s annual Fierce 15 report. Not surprisingly, the startups featured on this year’s list are raising the bar for medtech developers everywhere. Staff writer Andrea Park and Editor-in-Chief Ayla Ellison discuss a few of the 15 startups that made the cut. 

Plus, in this episode, we cover Illumina and Carl Icahn's proxy battle, Sanofi slashing insulin prices and more of this week's top headlines. 

To learn more about the topics in this episode: 

• Fierce Medtech's 2022 Fierce 15
• Illumina, Carl Icahn trade jabs amid looming proxy fight over $8B Grail buy
• Biogen, Novartis deliver one-two punch to Sangamo, walking away from deals in quick succession
• AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump
• Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma
• Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon
• Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices
• California invests $50M to partner with Civica Rx on insulin manufacturing

The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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The sudden failure of Silicon Valley Bank sent shock waves across global markets. Fierce Biotech Senior Editor Annalee Armstrong talked with Kiah Haslett, managing editor of the publication Bank Director, about how SVB’s failure came to be and what to expect next.

Armstrong and Fierce staff writer Max Bayer chat about how the biotech sector reacted given that SVB served almost half of all venture-backed technology and life sciences companies. They reflect on what surprised them as journalists covering the SVB news. Plus, in this episode, we cover Pfizer's blockbuster Seagen buyout, an expanded antibody-drug conjugate collaboration and more of this week's top headlines. 

To learn more about the topics in this episode: 

• UPDATE: SVB failure triggers shock waves across biotech industry
• UK biopharma body praises bank for keeping doors open at life science startups by rescuing SVB UK
• Insulet tapped to replace SVB on S&P 500 index after bank collapse
• Biden says America's 'banking system is safe' after regulators back up all SVB deposits
• With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs'
• Synaffix, MacroGenics crack open ADC pact, tacking on $2.2B, 4 more programs
• Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US
• Lilly's 10-year bet on treating Alzheimer's before symptoms start ends in failure
• PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company
• FDA oncology chief aims to open up accelerated approval for earlier cancer treatment under 'Project FrontRunner'
• Podnosis, a Fierce Healthcare podcast

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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2022’s slate of life sciences M&A deals didn’t meet expectations. But the year still featured tens of billions of dollars worth of biopharma acquisitions. Querida Anderson and Eric Sagonowsky discuss the top deals of the year. 

Also on the show, Kevin Dunleavy and Fraiser Kansteiner reflect on last year’s largest buyout—Amgen's $28 billion deal for Horizon Therapeutics. They explore what it potentially means for the buyer's market this year. Plus, this week's top headlines and Max Bayer's and Kansteiner's scoop on Johnson & Johnson's R&D overhaul and layoff plans.

To learn more about topics in this episode:

• The top 10 biopharma M&A deals of 2022
• Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war
• J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries
• Gilead's Trodelvy snags vital breast cancer nod. But AZ, Daiichi's Enhertu casts long shadow
• Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics
• Roche races to regulators after matching AstraZeneca's rare disease blockbuster in phase 3
• Call for nominations: The most influential people in biopharma in 2023

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In October 2022, the Society for Immunotherapy of Cancer released a checklist for running phase 3 cancer immunotherapy combination studies. SITC's aim with these guidelines is to maximize the value of these trials. In this episode, Fierce Pharma staff writer Angus Liu discusses the checklist with Dr. Michael Atkins, the first author.

To learn more about topics in this episode:

• Moderna checks a few boxes in phase 3 mRNA flu shot trial, but misses on B strains and safety
• BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software
• Apellis wins FDA approval for first geographic atrophy drug
• With FDA approval for Filspari, Travere turns Bristol Myers castoff into unique drug for rare kidney disease

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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Jeff Beck of BioCare is in the hotseat for this edition of The Top Line.

Beck is the Chief Development Officer at the company, which stands tall as a pioneer in specialty product distribution with over 40 years of experience dating back to hemophilia therapies.

During the conversation, Beck provides an inside look at the rapidly evolving specialty distribution landscape. He outlines how the patient-centric model is working well and is supported by efficient supply chains. However, the future will demand increasing personalization to handle a wider range of complex product archetypes like cell and gene therapies. This, Beck says, calls for expanded data capabilities around inventory visibility, site analytics and dissecting the patient journey.

Beck also goes on to explain how new regulations like the Inflation Reduction Act will impact specialty distribution, and why emerging manufacturers will increasingly rely on experienced partners like BioCare.

Don't miss this insightful discussion on meeting today's specialty distribution needs while paving the way for tomorrow's innovations.

Tune in now.

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On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.

To learn more about the topics in this episode: 

• Emergent makes history with first FDA nod for over-the-counter naloxone
• Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
• Adapt tests ads urging opioid users' loved ones to stock Narcan at home
• Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
• Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod

The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

The Fierce Biotech team published a four-part series this week exploring cell therapy, a modality that has faced clinical challenges, manufacturing constraints and multiple practice-changing events.  

In today’s episode, Fierce’s Annalee Armstrong and Gabrielle Masson discuss the series of special reports and key insights from their interviews with multiple experts.  

To learn more about the topics in this episode: 

• Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology
• Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology
• Biotech faces a reckoning: 'We've lost our luster in cell therapies'
• Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
• From cell collection to commercial contracting: Advancements in cell & gene therapy manufacturing (Part II)
• Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)

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In this episode of "The Top Line," we talk with Fierce’s Max Bayer and Angus Liu about the most important news coming from this year's annual BIO conference. We also cover a COVID lawsuit, an FDA-approved app, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• ASCO: After lung cancer fails, Roche's faith in TIGIT rewarded as tiragolumab shows signs of life in liver cancer
• Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer
• Roche, with HER2 franchise under pressure, pays $70M for breast cancer brain metastases prospect
• Takeda pledges up to $1.13B for rights to Hutchmed's cancer drug fruquintinib outside of China
• BIO: Moderna to test mpox vaccine in humans this summer
• BIO: Jazz is auditioning new bandmates in an M&A market ripe with talent
• BioNTech to defend itself against COVID-19 vaccine injury claim in Germany
• Salvation or 'death warrant'? Erytech's war with activist investor rumbles on as merger vote nears
• RSV vaccine awareness low among older adults, but majority would ask their doc about new shots: survey
• Huma nabs FDA nod for AI-backed disease management platform
• Medtronic warns cardioversion can fry some Vanta neurostimulators

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of agencies. This stipulation, called the Chevron deference, gave agencies room to advance their regulatory priorities. 

The Supreme Court overturned the doctrine in June, bringing significant implications for the healthcare industry and federal regulators like the FDA. 

In this week's episode of "The Top Line," Fierce Pharma’s Kevin Dunleavy chats with Project Farma President Anshul Mangal about the potential impact on the biopharma industry. 

To learn more about the topics in this episode: 

• Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies
• The Supreme Court just limited federal power. Healthcare is feeling the shock waves
• How Chevron's demise could impact employers, purchasers and health payers

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In this podcast, learn why we’re bringing forward boron neutron capture therapy (BNCT) as an approach to treat malignant tumors, and how it may become a powerful option for cancer patients.

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The Fierce Pharma Marketing team publishes a special report each year on the top pharmaceutical drug ad spenders. This year’s report, which includes numbers for 2023, was published on Monday.  

AbbVie was the standout in this edition, having spent heavily on ads for Skyrizi and Rinvoq. Overall spending on the top 10 ads also experienced a sizable increase compared to the previous year. 

In this week’s episode of “The Top Line,” Fierce Pharma Marketing Senior Editor Ben Adams and Deputy Editor Andrea Park discuss the report, providing key insights and takeaways.  

To learn more about the topics in this episode:  

The top 10 pharma drug ad spenders for 2023

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In this episode of "The Top Line," we talk with Fierce’s Andrea Park and Gabrielle Masson about the latest from the American Diabetes Association's annual conference. We also cover a statement about transgender care, light therapy, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• 'Podnosis': Medicaid eligibility determinations, healthcare for the LGBTQ+ community
• Introducing the Fierce 50: Honoring healthcare and biopharma champions fighting for patient care
• Lilly links oral obesity drug to 15% weight loss, setting bar for Pfizer in blockbuster battle
• Boehringer's new data drop shows 19% weight loss for phase 2 obesity prospect
• UPDATE: Lilly's next obesity drug just cut an average of 58 pounds—prompting an all-out phase 3 blitz
• Let there be light: Scientists report new progress in quest to treat afib with optogenetics
• UK's flagging clinical trial sector faces fresh challenge as National Cancer Research Institute set to close
• Biotech leaders protest 'actively harmful' bans on gender-affirming care
• Know Labs unveils first prototype of portable, noninvasive glucose monitor
• Embecta dives deeper into Type 2 diabetes tech with Tidepool team-up
• Fitterfly's diabetes digital therapeutic cuts blood sugar, weight in real-world trial

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

We’d love to hear from you! If you have a comment about this podcast or if you have a tip for a future episode of The Top Line, you can reach us at this link. 

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Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases.

Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges.

In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani, Global Product Manager at Digital Biology Group, discusses the critical need to accurately quantify HEK293 DNA in biotherapeutics to ensure patient safety and regulatory compliance.

Gurnani highlights the risks of residual DNA integrating into a patient's genome, potentially causing cancer or genetic abnormalities. She also addresses the limitations of traditional quantification methods like qPCR, which can be time-consuming and prone to errors.

We also look at some key innovations in the field, such as Bio-Rad’s Vericheck ddPCR HEK293 Residual DNA Quantification Kit that can minimize false positives by specifically targeting HEK293 DNA.

For deeper insights into these challenges and innovations, listen to the full episode.

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In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech. Join Deputy Editor Andrea Park and Senior Editor Annalee Armstrong as they reflect on the inspiring stories of the women who made this year’s list.

To learn more about the topics in this episode: 

• 2023's Fiercest Women in Life Sciences
• The Fierce 50 of 2023 
• Fierce 50 Awards Gala 

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In this episode of "The Top Line," we talk with Vimala Raghavendran, the vice president of informatics and product development at U.S. Pharmacopeia, about the factors causing the ongoing chemotherapy shortage. We also cover the Grail harassment lawsuits, CRISPR for Alzheimer's drug development, and the rest of the week's headlines. 

To learn more about the topics in this episode:

• BridgeBio heart disease drug vindicated with phase 3 victory, plots FDA submission this year
• The Future of Biotech
• Grail sued by 3 women over alleged 'frat house' culture, harassment and retaliation
• Scientists turn CRISPR scissors to genes involved in Alzheimer's
• National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them
• FDA to allow temporary overseas production to shore up supplies of chemo drug
• FDA can't solve drug shortages on its own, agency's oncology chief says

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

2022 was the third straight year where the coronavirus pandemic had an extreme effect on the revenue of several biopharma companies. Pfizer became the first company in industry history to rack up more than 100 billion dollars in sales. We discuss how other companies fared in 2022 and what we can expect this year. 

To learn more about the topics in this episode: 

• The top 20 pharma companies by 2022 revenue
• Big Pharmas finally strike with GSK, Merck acquisitions, signaling accelerating pace of M&A
• Merck & Co. inks $11B Prometheus takeover, firing starting gun on race for blockbuster bowel market
• GSK coughs up $2B to buy Bellus for late-phase rival to Merck & Co.'s stuttering gefapixant
• Medtronic embarks on monthslong global layoffs, with total cuts unknown
• Eli Lilly adds $1.6B to its manufacturing spending plan in Indiana, breaking a company record
• J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows

The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our "Fierce" journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In the fast-paced field of life sciences, digital pathology is poised to be a game-changer.

In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx).

Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as the utilization of whole slide images for companion diagnostic interpretation.

Pointing to the amplified scrutiny on Laboratory Developed Tests (LDTs) and the emerging CDx guidelines in the EU and China, she emphasizes the importance of aligning with agencies: “Oftentimes we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed.”

Clark echoes these sentiments, first highlighting the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring, and then offering an optimistic outlook on the transformative potential of AI in the realm of multiplexing assays.

For a deep dive into the opportunities presented by digital pathology and CDx development, tune into the full episode.

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This week on “The Top Line,” we explore the most anticipated drug launches of 2024. Editor-in-Chief Ayla Ellison engages in a conversation with Fierce Pharma Marketing Senior Editor Ben Adams about the drugs likely to launch this year with the most significant sales potential by 2028.

To learn more about the topics in this episode:

• Top 10 most anticipated drug launches of 2024
• BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK
• Bristol Myers Squibb has targeted launch plan for ‘multi-billion-dollar opportunity’ in Karuna schizophrenia drug
• Meet Madrigal Pharmaceuticals, which wants to be your liver's No. 1 fan

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In this episode of "The Top Line," our Fierce reporters tackle topics like the trends we saw at Cannes Lions, the cancer drug shortage, and the top compensated CEOs in the industry. 

To learn more about the topics in this episode:

• National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them
• FDA to allow temporary overseas production to shore up supplies of chemo drug
• FDA can't solve drug shortages on its own, agency's oncology chief says
• Play it loud: Cannes winner pitches sound therapy as extra tool in arsenal against cancer
• How Eversana roared back from rejection to craft Cannes-winning campaign hospitals couldn't ignore
• In a year of turnover, Seagen doled out $126M to a trio of CEOs
• The 15 highest paid pharma CEOs of 2021
• UPDATED: Moderna CEO Stéphane Bancel earned $19.4M in 2022 but made much more in stock sales

"The Top Line" and "Podnosis" are produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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For sponsors, value lies in equipping sites with the technology that makes securely capturing pre-screening, recruitment, and enrollment data easier. 

In this interview, Alicia Asgari, the Senior Manager of Solutions Consulting at OneStudyTeam, discusses the need for appropriate technology solutions and strategies for sponsors and sites to solve recruitment and enrollment challenges. OneStudyTeam is a provider of cloud-based software and enrollment solutions for sponsors, sites, and CROs with the mission to accelerate the development of new and lifesaving therapies.

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Paul Beresford and Lou Welebob of Agilent Technologies discuss how partnerships are vital in addressing the evolving needs of pharma for complex diagnostics and CDx development.

Discussions center around the importance of working with pharmaceutical companies to drive medical innovation and improve patient outcomes, helping to speed up the process of bringing the right treatments to the right patients at the right time.

Topics discussed include the importance of broadening technological focus on immunohistochemistry, such as bridging into digital biology and imaging as well as multiplexing. Spatial biology is touched upon, specifically looking at how spatial profiling can be used to determine cell proximity within the tumor microenvironment, potentially correlated to drug efficacy.

Looking ahead, both speakers point to the potential to use machine learning in key areas such as the development of assays for use across laboratories globally.

To discover the full range of insights from life sciences, diagnostics and applied chemical markets specialist Agilent Technologies, listen to the full podcast.

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After a complicated 2022, the new year offers a course correction for the obesity market. We'll hear from Fierce's Fraiser Kansteiner and Querida Anderson on the numerous opportunities ahead in the obesity market. 

Also on the show, Fierce's Kevin Dunleavy and Eric Sagonowsky reflect on the the 37 new drugs approved in 2022. Plus, this week's headlines. 

To learn more about topics in this episode:

• 2023 forecast: With Novo's Wegovy on a supply rebound, 2023 offers course correction and obesity showdown with Lilly
• Novo Nordisk's semaglutide set to tackle obesity with hotly-anticipated FDA green light
• Lilly's tirzepatide slides into FDA fast lane for obesity, turning up heat on Novo Nordisk's Wegovy
• 2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
• Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira
• Amgen's Humira biosimilar Amjevita hits the market with 2 different list prices
• In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion
• Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023. And Paxlovid won't fare much better
• Philips cuts another 6,000 jobs as CPAP recall, supply chain snags send 2022 sales down 3%
• Researchers predict Alzheimer's progression 3.5 years early with unique blood test

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

For a long time, AbbVie’s Humira was the world’s top-selling drug. But the bestseller will finally face biosimilar competition. Plus, this year is also chock-full of other big-name, blockbuster drugs headed for the patent cliff. In this episode, we discuss 2023's patent story. 

Plus, we cover how Johnson & Johnson is looking to end its talc litigation with a sweeping settlement and more of this week's top headlines. 

To learn more about the topics in this episode: 

• The top 10 drugs losing US exclusivity in 2023
• J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer
• FTC reverses course, orders Illumina to unravel Grail deal
• Cytokinetics' pipeline tumble continues after ALS med flops in phase 3 interim look
• Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer
• Butterfly nets AI ultrasound clearance for spotting signs of lung disease
• Intra-Cellular crowned your winner of the Fierce Madness Drug Ad Tournament 2023

"The Top Line" is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In this episode of “The Top Line,” we explore the next potential wave of mental health therapy: psychedelics. 

Fierce Biotech's Max Bayer sits down with Scott Aaronson, M.D., a seasoned clinician and psychiatrist with over 30 years of experience in the field. They discuss how psychedelics might be used in the treatment of conditions such as depression, substance addiction, PTSD, anorexia, and more. They also examine the obstacles developers face as they advance their studies.  

To learn more about the topics in this episode: 

• MDMA approval filing nears after drug hits again in phase 3, showing consistent PTSD improvements
• Early clinical data on psilocybin in anorexia point Compass to potential new opportunity
• Otsuka adopts new Mindset, dropping $59M to buy Canadian psychedelic biotech

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This week on “The Top Line,” we’re diving into the topic of diversity in clinical trials, examining both the progress made and the ongoing work needed to ensure inclusivity. 

In this episode, Fierce Biotech Senior Editor Annalee Armstrong engages in a conversation with Karen Correa, Ph.D., Head of Global Clinical Operations at Takeda and Executive Sponsor of Trial Diversity. Correa shares her insights into why it's imperative for pharmaceutical companies to adapt and prioritize diversity in their clinical trials, while also discussing the initiatives Takeda has undertaken in this area. 

To learn more about the topics in this episode: 

• Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds
• ASCO, ACCC become latest to call for clinical trial diversity with 6 strategies for improving inclusion in cancer studies
• Digital Medicine Society rolls out initiative to improve diversity in clinical trials
• FDA's Richard Pazdur, sector leaders push for private-public partnership to boost DEI in cancer drug development

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In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  

Genevieve Kanter, Ph.D., a professor at the USC Sol Price School of Public Policy, joins Fierce's Kevin Dunleavy to discuss the implications of a study published in July in JAMA Health Forum, which found the FDA's propensity to favor positive panel recommendations. They explore the impact of this potential bias on drug development and public health. 

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Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. In this week's episode of "The Top Line," we dive into the current state and implications of the proposed buyout.  

Fierce Pharma’s Fraiser Kansteiner is joined by former FTC policy director David Balto. They discuss the likelihood of the deal going through, potential regulatory hurdles and what the transaction could mean for the greater CDMO landscape.

To learn more about the topics in this episode: 

• Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'
• Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge

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On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner continues our mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.

To learn more about the topics in this episode: 

• Emergent makes history with first FDA nod for over-the-counter naloxone
• Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
• Adapt tests ads urging opioid users' loved ones to stock Narcan at home
• Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
• Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
• Virtual Roundtable: Remote Therapeutic Monitoring, The Future of Virtual Care Management

The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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In this episode of the "The Top Line," Fierce’s Anastassia Gliadkovskaya talks with Autumn Ehnow, vice president of Medicines360, a nonprofit pharma with a mission to produce and sell affordable medications. They talk about the need to democratize access to medications like emergency contraception, particularly for women. We also cover Elizabeth Holmes, the state of Alzheimer's research, plus more headlines. 

To learn more about the topics in this episode: 

• Startup Curae Pharma360 partners with Direct Relief to distribute free contraceptives to safety-net clinics
• CMS proposes rules to expand access to contraception under ACA
• HHS warns retail pharmacies to not curb access to birth control, abortion pill prescriptions
• Hunt for new non-hormonal birth control sends scientists under the sea
• FDA can't solve drug shortages on its own, agency's oncology chief says
• Theranos' Elizabeth Holmes reports to Texas prison to begin 11-year sentence
• The Alzheimer's pipeline is as strong as ever. Now, we just need the patients
• Small biotech turns CRISPR against bacteria, reducing E. coli in small early study

"The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Some expect the next few years will be an overall down period for pharma growth. So, Fierce’s Kevin Dunleavy invited Harietta Eleftherochorinou, Ph.D., of IQVIA to "The Top Line" to discuss why pharma needs to employ artificial intelligence and machine learning tools to stay ahead of the curve.

To learn more about the topics in this episode: 

• 2023 forecast: An 'inflection point' for biopharma, fueled by a flood of AI and machine learning products
• Covis finally pulls preterm birth drug Makena after 12-year accelerated approval odyssey
• FDA sounds out de novo clearance for neuromodulation device to treat tinnitus
• FDA widens Lilly's Verzenio breast cancer reach, removes test and menopausal status demands
• Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members
• AbbVie CEO Gonzalez scored $26M in 2022 pay as cash cow Humira neared patent cliff
• FDA delays BioMarin's gene therapy approval decision by 3 months

The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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In this episode of "The Top Line," we delve into the uncharted territory that pharma marketers face, from harnessing AI's potential to navigating the Inflation Reduction Act. Ayla Ellison, editor-in-chief of Fierce Life Sciences and Healthcare, engages with three industry experts to unravel the opportunities and challenges that lie ahead.

In the first segment, Robert Allen, the leader behind engagement and channel planning for U.S. Oncology at Bristol Myers Squibb, shares his insights into strategic planning for customer engagement and channel strategies. Next, Terry Terifay, the Chief Commercial Officer at Azurity Pharmaceuticals, offers a glimpse into what the future holds for the industry. In the third segment, Dorothy Gemmel, the Chief Commercial Officer of GoodRx, shares the projects she's excited about and her biggest piece of advice for others in the industry."

To learn more about the topics in this episode: 

• Will Big Pharma engage in Medicare price negotiations? Merck, AZ and BMS say they will

• Providers can now see patients' insurance coverage in GoodRx's cost comparison tool

• Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

• GoodRx, Walgreens team to lower prices for 200 drugs

• Fierce Pharma unveils the winners of the 5th annual creativity contest for outstanding marketing campaigns

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This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.

One of them is the report of a 7th person who has likely been cured of HIV. And there’s something unique about this case that has sparked excitement among scientists.

The other one is the report of a long-acting injection that showed 100% efficacy in preventing HIV infection in a phase 3 trial. Some experts have hailed the PrEP candidate as a game-changer.

To dive deeper into these studies, Fierce Pharma’s Angus Liu interviews Jared Baeten, M.D., Ph.D., senior vice president and head of clinical development of the virology therapeutic area at Gilead Sciences. 

To learn more about the topics in this episode: 

• With seventh person seemingly cured of HIV, signs of hope for a broader cure 

• Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention 

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In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report. 

Fierce Biotech's Annalee Armstrong and Gabrielle Masson take you behind the scenes to explore the meticulous selection process and share interesting highlights from this year’s honorees. 

To learn more about the topics in this episode: 

• Introducing Fierce Biotech's 2024 Fierce 15
• Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSE
• Fierce 15: Where are they now?

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In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients.

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
• After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
• Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients

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At Fierce Biotech, we love a big M&A deal, but valuation does not always equal the most exciting.  

In this week's episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest acquisitions in recent years.  

From obesity to radiopharmaceuticals, they give you the Fierce Biotech team’s thoughts on who got the best deal. 

To learn more about the topics in this episode:  

• Top 10 smartest deals in biopharma 

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In this episode of 'The Top Line' we reply an important show from April 28, 2023 regarding Narcan. 

On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives.

To learn more about the topics in this episode: 

• Emergent makes history with first FDA nod for over-the-counter naloxone
• Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts
• Adapt tests ads urging opioid users' loved ones to stock Narcan at home
• Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M
• Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod

The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

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In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014. 

A decade later, she revisits these trailblazers to see how they’ve navigated the biotech landscape.  

To learn more about the topics in this episode: 

• Fierce Biotech's Fierce 15 of 2014

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The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. 

In today’s episode, Fierce Pharma’s Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.  

To learn more about the topics in this episode: 

• FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe
• Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

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Fierce Pharma publishes a yearly special report highlighting the top 20 pharmas based on their revenue. The most recent edition, published this month, ranks each pharma based on their total revenues for 2023.  

This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy break down the numbers, highlight key trends and share some of the biggest changes at the top and bottom of the rankings year over year.  

To learn more about the topics in this episode:  

• The top 20 pharma companies by 2023 revenue
• The top 20 pharma companies by 2022 revenue

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