BioCentury This Week BioCentury

Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital. 

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary.
BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital. 

Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and the likely key factors for CMS as it determines prices for the first cohort of drugs in Medicare drug price negotiations under the Inflation Reduction Act. They also preview BioCentury’s first R&D conference — Grand Rounds — which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville, Sept. 9-11. This week’s podcast is sponsored by Jeito Capital. 

M&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for Cancer Research and the editors’ insights on why degrader-antibody conjugates are emerging as the next contenders to build on the success of the antibody-drug conjugates paradigm. Editor in Chief Simone Fishburn also previews Grand Rounds, BioCentury’s first R&D conference, which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville Sept. 9-11. To learn more about BioCentury Grand Rounds and opportunities to present, see the conference website. This week’s podcast is sponsored by Jeito Capital. 

Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why the court’s pending decision could safeguard FDA from judicial second-guessing. The team also analyzes the agency’s first ever complete response letter for lack of confirmatory trial enrollment.  This week’s podcast is sponsored by Jeito Capital. 

Bills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the measures.
They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with Atlas Venture’s Bruce Booth, and lessons from Orchard Therapeutics on what it takes to get FDA’s approval for an ultrarare disease drug.
For BioCentury’s complete coverage of the Biosecure Act and similar legislation in Senate, visit the Hot Topics page for the topic