BioCentury This Week

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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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when and how CMS is going to set prices for drugs selected for scrutiny and what the chances are that the act can be repealed or modified.

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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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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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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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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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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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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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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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 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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