BioCentury This Week (BioCentury)

Weathering the bear market. Oncology chief’s change in thinking on PD-1 therapies. Plus BioCentury’s 2021 innovative start-ups. This week’s podcast is sponsored by ICON.

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FDA and its advisory panel of oncology experts have repudiated the use of China-only data for regulatory submissions in the U.S. How will China's cancer companies adjust to this new regulatory environment? Plus, BioCentury's editors discuss the upcoming vote on Rob Califf, President Biden's nominee to become the next FDA commissioner, and the latest translational trends in cancer, infectious and neurology as identified BioCentury's Distillery. Sponsored by ICON, the clinical research organization offering flexible partnership model for biotech companies. Learn more at ICON.

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Newly confirmed FDA commissioner Rob Califf will be prioritizing a proactive communications strategy, including combating misinformation about science, whilst guiding FDA through the pandemic and trying to keep the agency above Washington’s political fray. Plus, BioCentury’s editors discuss how late-stage investors are adapting to biotech’s bull market and Amgen’s application of its rapid development strategy to its pipeline. Sponsored by Jeito Capital, a global leading investment company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking innovation. Learn more at Jeito Capital.

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Industry leaders have vowed to disengage with Russia until it stops its invasion of Ukraine and respects its neighbor’s sovereignty. What's the likely impact of their pledge and what are the implications of the crisis in Ukraine for biopharma companies around the globe? Plus: Assessing the latest cut of data for Intellia's pioneering in vivo CRISPR-Cas9 therapy and key takeaways from Washington Editor Steve Usdin’s conversation with ICER’s Steve Pearson on The BioCentury Show. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.

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War Pulls Biotech to Ukraine, Out of Russia: BioCentury's editors look at how the worsening crisis in Ukraine is affecting the global life sciences community, and discuss the challenges and tactics for removing Russian capital from biotech VC funds and the takeaways form a Guest Commentary by 4BIO Capital’s Dima Kuzmin that calls for a thoughtful approach to economic disengagement from Russia. Plus: what highly anticipated TROPiCS-02 data means for Gilead's Trodelvy sacituzumab govitecan-hziy and Senior Editor Karen Tkach Tuzman returns for another monthly installment of What’s on Tap in the Distillery. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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Chinese immuno-oncology companies are changing how they interact with FDA as they seek approval of PD-1 programs. On this episode of BioCentury This Week, BioCentury’s editors discuss takeaways from a survey of CEOs and R&D heads developing PD-1 or PD-L1 inhibitors about what’s next for their programs. The team also previews translational data expected at next month’s meeting of the American Association for Cancer Research (AACR) and legislation making its way through Congress as the House Energy and Commerce Committee’s health subcommittee prepares to gather. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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The importance of FDA’s approval of Bristol Myers' LAG3 inhibitor Opdualag nivolumab/relatlimab for melanoma, the pharma’s disruptive marketing strategy and what’s next among checkpoints in the clinic headline the latest BioCentury This Week podcast. BioCentury's editors also discuss why there’s still a lot of excitement regarding the IL-2 cancer pipeline despite last week’s setback for Nektar Therapeutics and the paths less traveled to raising money as the downturn grinds on. This week’s podcast is sponsored by life sciences investment firm Jeito Capital. 

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AACR is just around the corner, and new data being presented at the conference details how stakeholders are improving the specificity of CAR T therapies in solid tumors and improving their ability to penetrate the tumor microenvironment. Plus, BioCentury’s editors discuss the upcoming FDA advisory committee for ALS therapy AMX0035 from Amylyx, including FDA’s stance on the efficacy data and the challenges around weighing the safety of a therapy for a patient community in desperate search of new treatments vs. maintaining an efficacy standard for approvals.

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Novartis is prioritizing “high-value,” multibillion-dollar assets as it reorganizes. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the Swiss pharma’s plans to reunite its oncology unit with the rest of its pharma business and carve out a new C-suite post to oversee strategy and growth. Plus: how Merck KGaA is changing the way it is building its pipeline following late-stage clinical disappointments and what to look for at the upcoming Association for Cancer Research (AACR) meeting. 

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BioCentury's editors break down CMS’s final coverage decision on amyloid mAbs for Alzheimer’s disease, focusing on what the lessons are from Aduhelm’s journey through FDA and CMS, and what sponsors of the next crop of Alzheimer's therapies should expect when seeking approval of their programs. Plus: highlights from the latest translational coverage in BioCentury’s Distillery, a call from FDA’s Patrizia Cavazzoni for increased funding to support regulatory innovation, and takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with EQRx Inc.’s Jami Rubin.

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Positive fund flows and modestly better performance by biotech indexes offer hints that the beginnings of a recovery could be possible in the near term, even as the financing drought grinds on. On a BioCentury This Week Special Report, BioCentury’s editors discuss the conditions, including clinical catalysts and M&A, that could spark a recovery for the biopharma sector. This week’s podcast is sponsored by Bio€quity Europe.

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Long-awaited proof of concept for AstraZeneca’s PARP-1-selective therapy opens the door to combination strategies previously limited by hematopoietic toxicity, Senior Editor Karen Tkach Tuzman says on the latest edition of BioCentury This Week. Tkach Tuzman surveys data from the growing DNA damage repair (DDR) field from this year’s American Association for Cancer Research meeting, and the team also discusses the legacy of outgoing NCI Director Ned Sharpless, concerns over McKinsey's work for FDA and life sciences clients and the latest crop of BioCentury Emerging Company Profiles. This week’s podcast is sponsored by Bio€quity Europe.

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The first clinical data from Nkarta’s CAR natural killer cell platform add to the growing evidence that a CAR may provide the efficacy boost NK cell therapies have needed. BioCentury's editors analyze the significance of the data, which drove a 141% gain in the biotech's stock. They also discuss the biopharma legacy of the late Sen. Orrin Hatch, how biopharma companies are coping with the extended lockdown in Shanghai, and takeaways from J.P. Morgan’s Mike Gaito appearance on The BioCentury Show. This week’s podcast is sponsored by Kendall Square Orchestra.

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Chinese biotechs face regulatory delays for their therapies due to pandemic-related barriers to inspections by Western regulators and FDA’s reluctance to accept China-only data. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a setback for surufatinib from Hutchmed could be a sign of things to come for its China peers. The podcast team also analyzes a flurry of FDA activity and assesses what the IPO by vaccine play HilleVax says about the market for fresh paper.  This week’s podcast is sponsored by Kendall Square Orchestra. 

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The House Energy & Commerce Committee has a bipartisan deal on reauthorizing FDA user fees that sets the parameters for FDA reforms, including enhancing accelerated approval and improving clinical trial diversity — but how much will the legislation change in the coming months and how? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the requirements for FDA, HHS, sponsors and other stakeholders that would come into effect under the House’s proposed user fee legislation and what’s next for the bill. The podcast team also discusses Howard University’s mission to address racial health disparities, and how the university brings a human focus to research that might have otherwise stuck to laboratory models.

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Industry’s dueling headwinds of capital and talent are the focus of this year’s Bio€quity Europe meeting, and in a special episode of BioCentury This Week, two veterans of the burgeoning Italian life sciences ecosystem, Sofinnova Partners' Graziano Seghezzi & Ambrosetti's Corrado Panzeri, say the country’s biotech sector now has the capital and networks to weather the storm.

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The sale of a minority stake in Sofinnova Partners to PE firm Apollo will allow the European VC to grow while retaining its independence. Fresh off a conversation with Sofinnova’s Antoine Papiernik, Associate Editor Stephen Hansen explains the 50-year-old firm’s proactive approach to finding a partner among private equity firms and what’s next for the firm now that it has more financial firepower. The podcast team also discusses the latest translational tidbits from BioCentury’s Distillery, the first look at clinical data from the CRISPR-based gene editing platform of Caribou and how biopharmas are weighing their commitment to Russian patients against calls to disengage from the country.  This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.   For more information visit, msd.com/licensing. 

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Even as industry is facing a global talent crunch, Europe’s biotechs have it better than ever, Medicxi’s Francesco De Rubertis said on a special edition of the BioCentury This Week podcast recapping the first two days of the Bio€quity Europe conference in Milan. He and MSD’s Khatereh Ahmadi joined the BioCentury podcast team to discuss the battle for top talent and the state of deal-making amid the ongoing downturn. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.   For more information visit, msd.com/licensing. 

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Ensuring that a biotech reaches its key inflection points as effectively as possible during the ongoing capital crunch affects a company across the board, including its people, pipeline and financing toolkit, Shorla’s Sharon Cunningham said on a special Bio€quity Europe edition of the BioCentury This Week podcast. Cunningham and BII’s Bobby Soni joined the BioCentury podcast team to discuss navigating the downturn as a CEO of a private biotech, the untapped talent pools able to run start-ups and the ecosystem in Bio€quity Europe’s next site, Ireland. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.).  For more information visit, msd.com/licensing. 

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On the latest BioCentury This Week podcast, BioCentury’s editors explore how biotechs are turning to tumor targeting, IL-15 expression and alternate cell sourcing to enhance the potency and longevity of NK cell therapies. The podcast team also discusses Janet Woodcock’s new remit at FDA, Bristol Myers Squibb's pullout from Russia and the bipartisan effort moving medical product user fee reauthorization legislation forward in both houses of Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.  For more information visit, msd.com/licensing. 

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The latest data cut for KRAS G12C inhibitor adagrasib from Mirati Therapeutics underwhelmed investors. On the latest BioCentury This Week podcast, BioCentury’s editors discussed the readout, which came in an abstract ahead of this week’s American Society of Clinical Oncology meeting, and previewed some of ASCO’s most anticipated data, which will emerge in “late-breaker” presentations. The podcast team also explored the legal battle over IP related to CRISPR editing in bacterial cells, the latest on an investigation by CStone Pharmaceuticals into a derivative investment that broke company policy, the launch of the Advanced Research Project Agency for Health and the status of user fee negotiations in Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre.  For more information visit, msd.com/licensing. 

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 Stellar ASCO data for Enhertu show how there’s “massive ground” that can still be covered and improved upon by applying new modalities against older targets, said Editor in Chief Simone Fishburn on the latest edition of BioCentury This Week. Fishburn and the BioCentury podcast team dig into the data for antibody-drug conjugate Enhertu from AstraZeneca and partner Daiichi Sankyo for previously treated HR-positive, HER2-negative breast cancer patients. They also assess how new modalities are breathing fresh life into HER3 and explore the themes raised by Fishburn in her conversation with Richard Pazdur, and some of his FDA colleagues at the American Society of Clinical Oncology conference in Chicago. The team also discusses the latest cut of data for tofersen from Biogen in SOD1-mutant amyotrophic lateral sclerosis. 

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Stellar data for Vertex Pharmaceuticals and CRISPR Therapeutics could set a high bar for the next generation of gene editing players to beat in β thalassemia and sickle cell disease, indications that had previously been considered as the best disease to show proof-of-concept for the modality, said Executive Director of Biopharma Intelligence Lauren Martz on the latest edition of BioCentury This Week. The BioCentury podcast team also reviews Associate Editor Stephen Hansen’s analysis of how the trend of private equity firms acquiring or partnering life sciences VCs will impact the financing environment, and Washington Editor Steve Usdin’s take on the one big difference between the PDUFA user fee bills making their way through the House and Senate. Senior Editor and Head of Discovery & Preclinical Development Karen Tkach Tuzman also reviews the latest highlights from BioCentury’s Distillery

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On the latest BioCentury This Week podcast, Washington Editor Steve Usdin details how the Advanced Research Projects Agency for Health is taking shape as the new U.S. agency seeks to deliver transformative science and the latest moves by Rep. Anna Eshoo to change its structure via legislation. The podcast team also explores the U.K. NHS’s deal with Pfizer Inc. and Shionogi & Co. Ltd. on a subscription-based payment pilot for antibiotics, which could serve as an example for other payers considering similar initiatives; why an IP agreement by the WTO will do little to move the needle on COVID countermeasures; and top takeaways from Zai Lab CEO Samantha Du on The BioCentury Show. In addition, they call for members of the biopharma community to participate in a BioCentury survey on the talent crunch facing industry. All responses will remain confidential.

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On the latest BioCentury This Week podcast, a pair of deals demonstrates how Galapagos CEO Paul Stoffels is shifting the Belgian biotech’s strategic focus from small molecules toward a diversified portfolio. Plus: why Friday’s Supreme Court decision to overturn Roe v. Wade sets the stage for legal and legislative battles that could have broad implications for biopharma and how a new crop of Indian biotechs are seeking to offer dramatically cheaper CAR T therapies. This week’s podcast is sponsored by the BioCentury-BayHelix East-West Summit 2022.

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AstraZeneca’s takeout of single-asset spinout TeneoTwo for $100 million up front is but the latest payout to shareholders in TeneoBio, who could stand to see even more upside in the years ahead, says Associate Editor Paul Bonanos on the latest edition of the BioCentury This Week podcast. Bonanos and the BioCentury editors also discuss how TeneoTwo investor Lightspeed Venture Partners has deepened its commitment to life sciences investing; Arch Venture Partners’ plans to deploy its new $3 billion venture fund; and the latest translational highlights from BioCentury’s Distillery and Translational in Brief sections. Plus: A preview of BioCentury's fall conference.

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Even with signs that the biotech winter may be starting to thaw, buysiders continue to expect more near-term pain for the sector as consolidation continues for smaller companies with limited cash and few options for raising more, Associate Editor Stephen Hansen says on the latest edition of the BioCentury This Week podcast. Hansen sums up the takeaway messages from BioCentury's 3Q22 Financial Markets Preview, detailing the impact of the barren financing landscape, investors’ priorities, and whether the sector has finally hit bottom. The podcast team also discuss an initiative by gene therapy companies to resolve and pre-empt immune-related toxicities seen in some Duchenne muscular dystrophy trials and the latest push by Congressional Democrats and the Biden administration to regulate the prices of some drugs.

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Sen. Richard Burr’s new approach to a critical medical products user fee bill funding FDA must be taken seriously because the clock is ticking, and it’s ticking loudly, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why Burr has introduced the bare-bones legislation and what’s at stake for industry in the weeks ahead. BioCentury's editors also discuss FDA’s neurodegeneration blueprint, clinical updates in ALS from Clene and base editing from Verve, and plans to reshape Novartis.

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As Severin Schwan’s steady hand on the tiller of Roche passes to another insider, BioCentury’s podcast team examines how initiatives during the outgoing CEO’s tenure, including those related to digital and data science, handed a solid deck of cards to diagnostics head Thomas Schinecker as he takes on the top job at the Swiss pharma. Plus: Washington Editor Steve Usdin assesses Sen. Richard Burr’s attempt to deliver a “clean” user fee bill, pharma and biotech executives’ chances to revise the drug price regulation provisions of the Democrats’ budget reconciliation bill, and why it might be too late for President Joe Biden to get a nominee for NIH director through Congress.

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Acquisition target Seagen has carved out such a differentiated portfolio of antibody-drug candidates that the company may not see much direct competition from other ADCs in the near term, BioCentury’s Lauren Martz says on the latest edition of the BioCentury This Week podcast. Martz and the BioCentury podcast team analyze how Seagen has built a pipeline around almost entirely first-in-class targets and assess how the latest cut of data for the company’s Padcev enfortumab vedotin-ejfv could broaden the ADC’s reach among cancer patients.

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The proposed $5.4 billion takeout of sickle cell company Global Blood Therapeutics by Pfizer is the latest sign of life in biotech M&A, BioCentury Associate Editor Paul Bonanos says on the BioCentury This Week podcast. Bonanos and colleagues explain how Pfizer plans to use its global reach to get Oxbryta to parts of the globe most affected by sickle cell disease, which disproportionately affects people of African, Middle Eastern and South Asian descent. Plus: how schizophrenia data from Karuna makes the biotech ripe for a takeout; amyloidosis data from Alnylam; and why Amgen’s latest data for Lumakras suggest the future of one of the most promising KRAS inhibitor combinations is now in doubt.

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A flurry of follow-on financings last week suggests a receptive market for companies with recent catalysts, BioCentury’s Paul Bonanos says on the latest BioCentury This Week podcast. Bonanos and colleagues discuss what last week’s offerings, led by schizophrenia company Karuna Therapeutics, say about which companies might be able to tap the public markets and under what circumstances. The podcast team also examines how computational protein design is shifting its center of gravity from mechanistic calculations based on physical forces to more powerful machine learning approaches trained on reams of data, and why a deal between the SEC and its Chinese counterpart on cross-border audits could be nearly in hand.

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Despite public market investors shying away from preclinical companies amid biotech’s bear market, large biopharmas have ramped up their deal making for early-stage assets and technologies and are willing to pay for access to new modalities, says BioCentury’s Stephen Hansen on the latest BioCentury This Week podcast. Hansen and colleagues also discuss the implications of FDA’s approval of gene therapy Zynteglo from bluebird bio Inc., and the latest advances and leaders in the field of epigenome editing.

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BioCentury’s 30th annual Back to School edition focuses on talent: where to find talent and how to nurture it. It’s a special Back to School package because the issue involves every person in the life sciences ecosystem at a critical time in the biopharma industry’s evolution, says Editor in Chief Simone Fishburn on the latest BioCentury This Week podcast. Fishburn and the BioCentury podcast team set the stage for the five-day Back to School series, which draws on analysis of BioCentury’s Talent Survey and interviews with more than 85 people at all career stages. The series includes dives into C-suites, the flourishing cohort of women CEOs, industry’s rising leaders and heavy lifters, VCs, regulators and more.

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The past two years have forced a reckoning for CEOs throughout the biopharma industry that will shape the next generation of success stories. On the second of five BioCentury This Week podcasts accompanying Back to School 2022, BioCentury’s podcast team discusses what makes a good CEO and how leaders are building teams to manage successful biotechs. BioCentury’s editors also draw on the results from BioCentury’s Talent Survey to discuss the flourishing cohort of women CEOs leading today’s biopharmas and how industry is thinking about diversity, equity and inclusion.

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Solving the biopharma industry’s management crunch will require today’s leaders to open their networks, and provide more leadership opportunities and mentoring to rising leaders, says BioCentury Editor in Chief Simone Fishburn. On the third of five BioCentury This Week podcasts accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the group of employees who see the C-suite as their next step, why they want to get there and the impediments they must overcome. BioCentury’s editors also assess how VCs are building boards to guide first-time CEOs, and discuss concerns that the increase in compensation across the biopharma sector has gotten out of hand. Access all of BioCentury's Back to School content here.

https://www.biocentury.com/topics/back-to-school-auth

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The need to recruit and train regulators is acute in developed as well as low- and middle-income countries, BioCentury Washington Editor Steve Usdin says. On the fourth of five BioCentury This Week podcasts accompanying Back to School 2022, Usdin and BioCentury’s editorial team discuss how drawing top talent means agencies must persuade candidates that careers are infused with purpose and support a vital mission. BioCentury Senior Editor Karen Tkach Tuzman says biopharma companies, facing their own talent crunch, will benefit from making themselves more visible, accessible and instructive to new entrants. Access all of BioCentury's Back to School content here.

https://www.biocentury.com/topics/back-to-school-auth 

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Digital fluency, the imperative to have an impact on society and an eagerness to make change now, not in future decades, mark the future leaders of the industry, says BioCentury Editor in Chief Simone Fishburn. On the fifth and concluding BioCentury This Week podcast accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the defining traits of industry’s incoming generation of leaders and the evolving skills required for the future of biotech. Access all of BioCentury's Back to School content here.

https://www.biocentury.com/topics/back-to-school-auth 

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Biopharma executives and investors are bracing for the impact of the newly passed Inflation Reduction Act. On the latest BioCentury This Week podcast, BioCentury's editors discuss pharma CEOs’ warnings that the law will reduce incentives for small molecule drug development, how biotech VCs may adjust deployment of their funds and how the government could implement the law.Turning to readouts from the European Society of Medical Oncology Congress, the BioCentury podcast team explains why the latest data for Amgen's Lumakras could shake up the KRAS inhibitor race and how Chinese investigator-initiated trials are accelerating CAR T innovation.

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A year after it reported its first clinical data showing CRISPR-based gene editing may live up to its promise, Intellia has provided evidence for the second time that its platform can knock down a clinically relevant target in the liver, and revealed the first data showing it can deliver clinical benefit. On the latest BioCentury This Week podcast, BioCentury's editors discuss the hereditary angioedema data for NTLA-2002. They also explain why the Inflation Reduction Act could have an outsized effect on the development of orphan drugs and how an Executive Order related to the Committee on Foreign Investment in the United States (CFIUS) signed by President Joe Biden singles out biotech and biomanufacturing for intensified foreign investment scrutiny.

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Everything’s at stake for FDA as user fee legislation approaches a critical deadline this week, Washington Editor Steve Usdin says on the latest episode of BioCentury This Week. Usdin details the next steps in the process, which FDA reforms are being dropped from the “clean” user fee bill and the future of healthcare legislation. BioCentury’s editorial team also recaps the top takeaways from Global Blood Therapeutics CEO Ted Love’s appearance on The BioCentury Show, previews the upcoming BioCentury-BayHelix East-West Biopharma Summit and assesses two upcoming milestones for Biogen: an FDA decision on tofersen for amyotrophic lateral sclerosis and Phase III data for Alzheimer’s therapy lecanemab that’s due from partner Eisai.

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The neurodegeneration field had two big wins with even bigger implications for the future of Alzheimer’s disease and ALSs, Executive Editor Selina Koch says on the latest episode of BioCentury This Week. Koch lays out the importance of the positive Phase III data for lecanemab in Alzheimer’s and the coming debate over access to the therapy, while also noting the potential for read-through to other neurodegenerative diseases from FDA’s approval of Amylyx's ALS drug Relyvrio. BioCentury’s editorial team also discusses mounting pressure on the Biden administration to curb outbound investments from the U.S. into China and the work of biopharma non-profit Life Science Cares.

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On the latest BioCentury This Week podcast, Washington Editor Steve Usdin details the circumstances leading up to Michelle McMurry-Heath’s resignation as CEO of BIO on Monday.  The podcast team also discuss BioCentury’s 4Q22 Financial Markets Preview, with Associate Editor Stephen Hansen assessing biotech’s attempt to emerge from the ongoing bear market recovery as inflation and rising interest rates foster a risk-off environment. Senior Editor Karen Tkach Tuzman discusses the latest translational tidbits from BioCentury’s Distillery and the impact Nobel Prize laureate Carolyn Bertozzi has had on the biotech industry.

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On the latest BioCentury This Week podcast, Senior Editor Karen Tkach Tuzman surveys the landscape of neoantigen cancer vaccines, touching on what’s changed in the past five years, 2022’s key readouts and what’s next for the field. Washington Editor Steve Usdin discusses the White House’s plans to use executive powers to reduce drug prices and, recapping his latest Editor’s Commentary, explains why he believes the U.S. and China should not allow rivalry in life sciences to turn into enmity that hurts patients. Finally, Editor in Chief Simone Fishburn assesses what turmoil in the U.K. means for the country’s burgeoning life sciences sector. 

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A pair of neurology companies are in the spotlight on the latest edition of the BioCentury This Week podcast. BioCentury’s editors assess how Lundbeck has evolved in the past five years, with a fresh emphasis on first in class in its revamped pipeline, and how Biogen could acquire its way into being a near-term growth company. BioCentury’s editors also discuss the Biden administration’s initiative that seeks to compensate for decades of underinvestment in the nation’s biomanufacturing capacity and takeaways from Nora Volkow, director of NIH’s National Institute on Drug Abuse, during her appearance last week on The BioCentury Show.

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McKinsey’s Franck Le Deu and BayHelix’s Guo-Liang Yu join the BioCentury This Week podcast to discuss globalization and cross-border innovation in the biopharma and preview the upcoming BioCentury-BayHelix East-West Summit. BioCentury’s co-founders — CEO Dave Flores, Chairman Karen Bernstein — and Editor in Chief Simone Fishburn and BioCentury head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the current environment for cross-border dealmaking and expected highlights of the East-West Summit, which will take place in Redwood City, Calif., Nov. 14-16.

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Biopharmas and investors have been warning of the Inflation Reduction Act’s potential to hurt patients — concerns that had been theoretical until last week, when Alnylam became the first company to announce that it may abandon plans to add an indication to an orphan drug’s label. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a provision in the IRA prompted the biotech to pause plans to start a Phase III trial of vutrisiran for Stargardt disease, what other therapies might be affected and the impact on patients. The BioCentury podcast team also discusses how Argenx is applying lessons of past orphan drugs to the launch of myasthenia gravis drug Vyvgart, as well as non-profit Accumulus Synergy Inc.’s plans to bring interactions between drug sponsors and regulators, and among regulators, into the 21st century.

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 BIO needs to pick a leadership team rather than a leader to give the trade group all the skills it needs moving forward, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and Editor in Chief Simone Fishburn discuss how BIO needs to address the challenges it now faces, as well as the results of BioCentury’s industry-wide survey on the state of the trade group.
BioCentury’s podcast team also assess the latest developments in RSV product development, the infectious disease pipelines of Pfizer and GlaxoSmithKline, and top takeaways from Fishburn’s conversation on The BioCentury Show with Andy Plump, who is president of R&D at Takeda 

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The lack of a “red wave” in the U.S. midterm elections sets up a “last gasp of old-fashioned, horse-trading politics” by lawmakers that could affect multiple pieces of life sciences legislation, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin details what’s at stake for biopharma in Washington during the remaining weeks of 2022, and what’s in store for life sciences in the next session of Congress. BioCentury’s editors also discuss trends at this year’s Society for Immunotherapy of Cancer (SITC) conference and the latest from the Distillery, BioCentury’s summaries of top translational papers highlighting new targets and technologies with disease-modifying effects.

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Cash conversation and sticking to priorities are essential for China’s biotech’s as they navigate today’s gloomy funding environment, Zhaoke Ophthalmology’s Lisa Feng said on a special East-West Summit edition of the BioCentury This Week podcast. Feng, who is CBO and CFO of Zhaoke, Jones Day’s Tony Chen and Paul Hastings’ Phoebe Yan discuss challenges of compliance risk in a digital world, China’s value-based procurement and IP landscape and the environment for IPOs and licensing deals for China’s biotechs.

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As China’s biopharma companies experience their first “biotech winter,” they should be engaged in active portfolio management, stopping projects that will not meet their investors’ expectations, Agio Capital General Manager Henk Joos said on BioCentury This Week. On a special East-West Summit edition of the podcast, Joos and Immune-Onc Therapeutics founder and CEO Charlene Liao discussed pipeline prioritization and other company survival tactics during today’s difficult financing environment.

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There are clear indicators of the maturation of China’s biotech sector, although east and west biopharma leaders have diverging views on how easy cross-border investment will be going forward, BioCentury’s Editor-in-Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn detailed her takeaways from the summit held last week, while Executive Editor Selina Koch reviewed her panel on the optimism R&D leaders have for the future role multi-omics can play in drug development. BioCentury editors also discussed the recent appointments of Chris Viehbacher as CEO of Biogen and David Epstein of Seagen and the challenges each face at their respective embattled biotechs.

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A model term sheet created by a consortium of academic institutions, VCs and law firms could reduce the negotiation time around life sciences start-ups for universities and VCs by 80%, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen detailed how the consortium came together and what it hopes to accomplish. The BioCentury editors also discussed implications of CSL's decision to price the first hemophilia B gene therapy approved by FDA at $3.5 million, as well as an FDA-NCI study that could serve as prototype for streamlined pragmatic trials.

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CTAD data for lecanemab showed more definitively than any past readout that targeting β-amyloid can lead to clinical benefit for Alzheimer’s patients, but the field is still wrestling with its use as a surrogate endpoint, BioCentury Executive Editor Selina Koch said on the latest BioCentury This Week podcast. Koch and the BioCentury podcast team break down the implications of data from Eisai and Roche at last week’s Clinical Trials on Alzheimer’s Disease meeting and look ahead to what’s next for the field. BioCentury’s editors also discussed how proposed changes to the U.K.’s R&D tax credit scheme could hurt British biotechs and what regulatory heads of global biopharmas who are members of the Charles Forum are envisioning for the post-COVID regulatory environment.

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The $28.7 billion takeout of Horizon Therapeutics by Amgen marks a continuation of the large cap biopharma’s return to the inflammatory and autoimmune space where it’s been most commercially successful, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and his BioCentury colleagues discuss the deal’s synergies as well as new targets and IL-18 data at the American Society of Hematology (ASH) conference, and the evolving landscape for selective estrogen receptor degraders.

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A strategy for navigating the Inflation Reduction Act is essential for every biopharma company, regardless of size or location, Washington Editor Steve Usdin said on a special edition of the BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss why creating an IRA strategy is so complex, when and how CMS is going to set prices for drugs selected for scrutiny and what the chances are that the act can be repealed or modified.

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Phase III results for resmetirom from Madrigal Pharmaceuticals are more than enough for a regulatory submission in non-alcoholic steatohepatitis, said BioCentury Director of Biopharma Intelligence Paul Bonanos. Bonanos and colleagues discuss what Madrigal got right in running its trial for the challenging NASH indication, and what’s next in the pipeline. BioCentury’s editors also assess highly anticipated, heavily scrutinized data from Moderna among other 4Q22 readouts from neoantigen programs, as well as translational highlights from BioCentury’s Distillery.

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The U.K. government is signaling that life sciences companies will be shielded from changes to an R&D tax relief policy that would otherwise leave small biotechs losing millions of pounds, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss the behind-the-scenes initiative by the U.K. BioIndustry Association to protect companies from being affected by serious unintended consequences of the policy changes as they continue to weather the bear market.
BioCentury’s editors also assess documents released by Congress that shed light on Biogen's rationale for how it priced Alzheimer’s drug Aduhelm, trends in FDA’s 2022 approvals and what the editorial team is looking for in the year ahead.

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A trio of billion dollar deals for late-stage and commercial assets featuring contingent value rights were among the highlights of the first day of the J.P. Morgan Healthcare Conference in San Francisco on Monday. BioCentury's editors discuss AstraZeneca's takeout of CinCor, Ipsen's buy of Albireo and Chiesi's acquisition of Amryt as well as other takeaways from JPM, the CERSI summit and the Neuroscience Innovation Forum. The team also discusses the latest in Alzheimer's.

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Investors broadly agree that biotech indexes won’t revisit the lows seen last year, but they’ll need their portfolio companies to survive until the industry begins its comeback, said Director of Biopharma Intelligence Stephen Hansen on the latest BioCentury This Week podcast. Discussing key takeaways from BioCentury’s 2023 Financial Markets Preview, Hansen detailed reasons to be positive in the year ahead, but cautioned that the financing windows will continue to be narrow and companies without a material catalyst this year need to deploy all the tools at their disposal to stay alive. Hansen and colleagues also discussed the milestones buysiders expect to drive excitement this year, and the outlook for M&A and partnerships, including the impact of the Inflation Reduction Act on dealmaking.

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New manufacturing systems for CAR Ts aren’t just about speed, Executive Director for Biopharma Intelligence Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the safety, efficacy and access benefits from rapid manufacturing platforms, and how these systems are set to change the way CAR T cells are delivered to patients. BioCentury’s editors also analyze the state of incentives for orphan drug development as the Orphan Drug Act turns 40, how the FTC’s non-compete proposal could have unanticipated effects for biotech, and what solutions former FDA commissioners are proposing to battle misinformation about science.

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BIO’s push for FDA to be more flexible on accelerated approval requirements is unlikely to resonate at the agency, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why BIO is concerned about the “erosion” of accelerated approval as FDA considers whether requiring confirmatory trials to be under way at the time of approval should be the default policy. He then details the trade group’s other top priorities. Also on the podcast: how imminent climate disclosure rules from the SEC could affect biotechs and recent trends in venture financing.

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Via new guidance and its Project Optimus, FDA is pushing companies to do dose-optimization studies instead of maximum-tolerated dose studies, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the burdens and benefits of the shift, in particular for biotechs. BioCentury’s editors also assess new challenges and opportunities for FDA and regulated industry now that the agency is starting to implement PDUFA VII and mandates from the spending bill passed by Congress late last year, including clinical trials diversity, and analyze a move in the House of Representatives to ban the use by federal or state governments of quality-adjusted life years (QALYs) to make health coverage or pricing decisions.

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Last week’s Oncologic Drugs Advisory Committee meeting to discuss PD-1 inhibitor Jemperli offered insights into new endpoints, single-arm studies and the future of FDA advisory committee panels. On the latest BioCentury This Week podcast, BioCentury’s editors assess how GSK's standout dataset in a rare form of rectal cancer could qualify the program for exceptions to FDA’s standard practices and what it could mean for patients. BioCentury’s editors also discuss signs of greater regulatory flexibility on the important but controversial overall survival endpoint, highlights from BioCentury’s Distillery and what NASDAQ debuts by Mineralys and Structure say about the state of the market for biotech IPOs. 

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On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the latest payment models from CMS could mean for cell and gene therapies, and how a new model could incentivize the completion of confirmatory trials for drugs with accelerated approval. BioCentury's editors also discuss the outlook for China's public markets and details around the genetic medicine delivery technology of recently launched Aera Therapeutics.

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Leaked drafts of legislation overhauling Europe’s pharmaceutical laws are causing consternation at biopharma companies. BioCentury’s editors discuss how the revised framework could cut IP protections and why any benefits from the legislation are not sufficient to attract investment to Europe. They also discuss the potential implications of an imminent ruling in a Texas lawsuit challenging FDA’s approval of abortion drug mifepristone, and comment on the departure of FDA’s Billy Dunn.

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On the latest episode of the BioCentury This Week podcast, BioCentury’s editors assess the challenges and opportunities facing Christopher Viehbacher as he begins to implement his vision for Biogen. The team also analyzes the state of play among NK cell therapy companies and discusses highlights from BioCentury’s Emerging Company Profile of Paratus Sciences Corp., a well-funded biotech being built around the idea that insights derived from the study of bat biology can be applied directly to human health and health security. This week’s podcast is sponsored by Jeito Capital.

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On the latest BioCentury This Week podcast, BioCentury’s editors assess the fallout from the collapse of SVB and the sale of SVB UK to HSBC. BioCentury’s editors also discuss the proposed $43 billion acquisition of Seagen by Pfizer, takeaways from CDER Director Patrizia Cavazzoni’s conversation with Washington Editor Steve Usdin on The BioCentury Show and Editor in Chief Simone Fishburn’s call for pharma to put more women in the C-suite. This week’s podcast is sponsored by Jeito Capital.

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On a special edition of the BioCentury This Week podcast, Editor in Chief Simone Fishburn and Director of Biopharma Intelligence Stephen Hansen assess the priorities for VCs and their portfolio companies in the immediate aftermath of the collapse of Silicon Valley Bank. They also discuss the gap left in the biotech ecosystem given SVB’s unique relationship with VCs and small companies, and what the knock-on effects may be on the sector as it continues to grapple with the bear market.

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 On the latest BioCentury This Week podcast, BioCentury’s editors assess how companies are upending pipeline and business strategies due to the Inflation Reduction Act, along with other takeaways from a survey on the IRA’s implications, conducted by BioCentury with the support of BIO. They also discuss CMS’s memo outlining how it intends to implement the IRA’s price-setting provisions, the T cell therapy landscape and insights from BioCentury’s Distillery. This week’s podcast is sponsored by Jeito Capital. 

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On the latest BioCentury This Week podcast, BioCentury’s editors assess responses to their VC survey regarding the collapse of Silicon Valley Bank in light of First Citizens’ acquisition of SVB. BioCentury’s editors also discuss how FDA’s advisory committee meeting for tofersen from Biogen and Ionis bolsters the case for neurofilament as a surrogate endpoint in amyotrophic lateral sclerosis, and why last week’s FDA draft guidance on accelerated approval could make cancer drug development harder for small biotechs. This week’s podcast is sponsored by Jeito Capital.

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On the latest BioCentury This Week podcast, BioCentury’s editors assess the implications of the FTC’s challenge to the $7.1 billion acquisition of cancer screening company Grail by next-generation sequencing company Illumina. They also discuss what’s at stake as the U.S. Supreme Court weighs arguments in the patent dispute over anti-PCSK9 mAbs between Sanofi and Amgen, and how CEOs of gene therapy companies are thinking about the competitive landscape at a time when products with preliminary evidence of safety and efficacy are dropping out of clinical development across multiple indications. This week’s podcast is sponsored by Jeito Capital.

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The ruling on abortion drug mifepristone issued Friday by Texas District Judge Matthew Kacsmaryk could destabilize drug regulation, opening up every FDA approval to second guessing by any court in the U.S., Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin assesses the implications of the decision and sheds light on the thinking of former senior FDA attorneys regarding the case. BioCentury’s editors also discuss the latest from venture firms Canaan, SR One, and newly launched Cure Ventures, and deliver takeaways from BioCentury’s recent webinar on the Inflation Reduction Act, “Navigating the IRA.”

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M&A such as Monday’s proposed takeout of Prometheus by Merck & Co. is one of the few factors that can help reverse the negative sentiment hanging over biotech, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues discuss Monday’s deal in the context of the prolonged market downturn as they assess the takeaways from BioCentury’s 2Q23 Financial Markets Preview. BioCentury’s editors also discuss the implications for FDA of court rulings on abortion drug mifepristone and how Gilead is building its oncology franchise.

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BioCentury’s analysis of AACR 2023 abstracts found new targets light on immuno-oncology, said Executive Director Lauren Martz on a special edition of the BioCentury This Week podcast. Martz and colleagues debated whether the findings suggest immuno-oncology is losing its luster, and assessed abstracts on next-generation PRMT5 inhibitors and first-in-human studies, as well as the latest data from Merck & Co. and Moderna on their neoantigen vaccine in melanoma.

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Top-tier European VCs are still attracting capital to deploy, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast, with LPs looking at funds’ track record and the track record for biotech. Hansen discusses how Forbion and Gilde will deploy their newly announced funds as well as what’s new in their strategies as they raise some of the biggest VC vehicles ever in Europe. BioCentury’s editors also discuss the U.S. Supreme Court’s mifepristone ruling and comments filed by the biopharma industry about CMS’s draft guidance on implementing the Inflation Reduction Act.

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Biopharma companies believe a draft law that seeks to overhaul European pharmaceutical policy for the first time in years is out of sync with innovation, Washington Editor Steve Usdin said on the latest BioCentury This Week. Usdin and colleagues assessed the EC’s proposals in the legislation, as well as what’s changed since a version of the draft was leaked earlier this year. BioCentury’s editors also discussed the implications of FDA’s acceptance of NfL as a surrogate endpoint for amyotrophic lateral sclerosis for companies with clinical neurodegeneration programs, plus the $5.9 billion takeout of geographic atrophy company Iveric bio by Astellas, and a deal by Sanofi to license rights to a Pompe therapy from Maze Therapeutics.

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Acelyrin last week parlayed a late-stage asset for hidradenitis suppurativa and veteran leadership into one of biotech’s largest-ever NASDAQ IPOs. On the latest BioCentury This Week podcast, BioCentury’s editors discussed how Acelyrin generated outsized demand for its offering and assessed Alzheimer’s data for Eli Lilly's donanemab, the promise and challenges of digital endpoints and takeaways from the latest BioCentury Show, which featured incoming FogPharma CEO Mathai Mammen in conversation with Editor in Chief Simone Fishburn. This week’s podcast is sponsored by Cancer Research Horizons.

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This year’s Bio€quity Europe conference aims to define what European biotech’s “playbook for success” should be in the industry’s “new normal,” BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the twenty-third incarnation of the May 14-16 meeting in Dublin. Seroba Life Sciences’ Alan O'Connell and Avectas' Mary Martin joined Flores and BioCentury Editor-in-Chief Simone Fishburn to outline the opportunities and challenges faced by Ireland’s biopharma ecosystem and preview some of the conference’s events and panel discussions, and EBD's Tina Elder detailed what to expect in terms of attendees at the event.

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For many private European biotechs, flat or down valuations have become the new normal as they struggle to raise money despite having quality science, +ND Capital’s Dani Bach said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. Investors, he said, are flocking to a handful of outsize fundraising rounds out of fear. In conversation Monday with Jeff Cranmer and Stephen Hansen of BioCentury and Poolbeg’s Jeremy Skillington, Bach described a bipolar fundraising environment in which the “bulk of companies are struggling for money and a few are getting massive amounts of money even beyond their wild expectations.” Bach, Skillington and BioCentury's editors also discuss Ireland's burgeoning biotech ecosystem, Europe's biopharma hubs and the performance of U.K.'s biotechs listed on the London Stock Exchange. This episode is sponsored by Jeito Capital.

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As biotechs continue to find their footing in the new normal of capital scarcity, the industry is beginning to see “green shoots” in M&A activity and preclinical deals, Ysios Capital’s Guillem Laporta said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. In conversation with BioCentury and Gilde Healthcare’s Joep Muijrers, Laporta described a fundraising environment where disruptive, innovative companies are continuing to get funded. The group also discussed Gilde’s plans for deploying its recent record VC fund, Ysios portfolio company Mineralys’ successful NASDAQ IPO and next year’s Bio€quity Europe conference, scheduled for May 2024 in San Sebastián, Spain.

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If FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.
Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bertagnolli to prioritize at NIH; and what the debt ceiling means for the life sciences. And on the heels of Bio€quity Europe, Editor in Chief Simone Fishburn delivers her insights from BioCentury’s European conference.
This week’s podcast is sponsored by Cancer Research Horizons.

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Two Phase I checkpoint inhibitor readouts due at ASCO 2023 are bringing excitement back to immuno-oncology, said BioCentury’s Lauren Martz on the latest BioCentury This Week podcast. Martz and her editorial team colleagues discuss what stands out about the data for LAG3 inhibitor fianlimab from Regeneron and anti-TIGIT mAb tiragolumab from Genentech.
The editors also break down takeaways from BioCentury's conversation on precision neuropsychiatry with Husseini Manji, co-chair of the U.K. Mental Health Mission, and assess BIO’s call for CMS to provide more clarity about its plans for implementing provisions in the Inflation Reduction Act that give some small biotechs a temporary exemption from Medicare drug price negotiation. This week’s podcast is sponsored by Cancer Research Horizons.

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ASCO’s kickoff included blunt comments from two CEOs who said the IRA is causing their companies to delay launches of cancer drugs for smaller indications, BioCentury Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discussed remarks at the American Society of Clinical Oncology conference by Novartis' Vasant Narasimhan and Genentech's Alexander Hardy regarding how the Inflation Reduction Act is forcing the companies to make difficult decisions regarding their pipelines and patients’ access to their therapies.
The podcast team also assessed highlights from ASCO’s data presentations, including antibody-drug conjugate readouts from partners AstraZeneca and Daiichi Sankyo, and Kelun Pharmaceutical and Merck & Co., as well as the emergence of Alkeus, which has attracted $150 million in series B money for its Stargardt program and Joshua Boger to its executive chairman position. This week’s podcast is sponsored by Cancer Research Horizons.

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A lawsuit over the Inflation Reduction Act by Merck & Co. suit signals to Republicans that the pharma has no compunctions about attacking Democrats, the Biden administration and the president himself, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleague discussed the significance of the move by Merck, its likelihood of success and why the pharma chose its combative tone for the first lawsuit challenging the Medicare drug price-setting provisions of the IRA.
BioCentury’s editors also assessed remarks at the BIO convention by FDA Commissioner Rob Califf related to the accelerated approval pathway, takeaways from Friday’s FDA panel on Alzheimer’s drug Leqembi and data presented at the American Society of Clinical Oncology annual meeting for multicancer early detection tests. This week’s podcast is sponsored by Cancer Research Horizons.

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Emer Cooke may have already cemented her legacy as executive director of EMA through her leadership of the European regulator during the COVID-19 crisis. But she still faces a big task in navigating the agency through Europe’s new pharma legislation, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. 
Usdin and colleagues discuss a wide-ranging fireside chat held last week in Amsterdam with Cooke, including how the agency adapted post-Brexit and the differences that need to be appreciated between the European and U.S. regulators.
BioCentury’s editors also discuss the future of induced pluripotent stem cells (iPSCs) in cell therapies, a conversation with Forbion’s Wouter Joustra, a management buyout of SVB Securities, and why Senate Democrats are holding back on confirming a new NIH director.

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FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.

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Full approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.
BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevidys delandistrogene moxeparvovec, the gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy that Usdin argued in an Editor’s Commentary shows flaws in evidence generation and regulatory processes.

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With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview. 
They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve.

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A hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest developments in industry litigation against the IRA and new FTC guidelines on antitrust rules.

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An analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentech Inc. CEO Alexander Hardy, and his perspective on how the Inflation Reduction Act (IRA) may impact future decision-making on drug development for small molecules. They also discuss takeaways from a Q&A with Leerink Partners’ Jeffrey Leerink and Dan Dubin, what’s next in BIO’s hunt for a permanent CEO, and the case of Stealth BioTherapeutics Corp. and whether the company’s regulatory experience raises questions about if FDA should improve the consistency with which it applies regulatory flexibility.

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A complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the dozens of companies that raised crossover cash before markets turned sour, as well as the digital transformation under way at Sanofi, which aims to use AI and data science to drive everything from candidate discovery to clinical trial planning, manufacturing optimization and supply chain management.

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There’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies.
BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the Scleroderma Research Foundation’s plans to bring the platform trial model to scleroderma.

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Circular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit in Cambridge, Mass., and the Nov. 2-3 China Healthcare Summit in Shanghai.

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What are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies.

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Constructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development.
BioCentury’s editors also assess why the FTC made a deal with Amgen that will allow the company’s $27.8 billion acquisition of Horizon Therapeutics to proceed, and how an agreement by Regeneron on international pricing of a COVID-19 mAb could clear the path to confirmation of Monica Bertagnolli as the next NIH director.

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That a broad swath of new money flowed into last week’s IPOs by RayzeBio and Neumora is a good sign for biotech and a departure from deals done last year, BioCentury's Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues assess the offerings and the companies’ aftermarket performance alongside NASDAQ’s six other top biotech IPOs of the year for signs of what’s next for companies looking to go public.
BioCentury’s editors also discuss what new regulatory requirements in China mean for Chinese biotechs hoping to debut on a stock exchange in the near future, as well as the latest developments in lawsuits related to the Inflation Reduction Act and an upcoming hearing on the IRA in the House.

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BayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the growth of cross-border dealmaking, and panel topics and speakers at the East-West Summit, which takes place Oct. 2-4 in Kendall Square.

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Biopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications.
BioCentury’s editors also discuss takeaways from BioCentury’s recent conversation with Sanofi CEO Paul Hudson; the latest developments for the Inflation Reduction Act; and notable biotech financings, including a $300 million private placement for Structure Therapeutics.

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