BioCentury This Week

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 reg...

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...

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 w...

 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...

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 th...

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...

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...

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 ap...

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 te...

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...

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...

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. H...

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...

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 ye...

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...

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 comp...

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 ant...

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 chance...

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 Ameri...

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 R...

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 o...

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 p...

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...

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...

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 sci...