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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.
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.
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.
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.
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.
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.
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.
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.
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.
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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