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Explore dynamic forces reshaping how therapies reach patients and gain actionable insights on market access and patient support from industry experts in this podcast series from Asembia's AXS25 Summit. Listen now. .png)
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Today’s Big NewsMay 9, 2025 |
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Wednesday, May 14, 2025 | 11am ET / 8am PT Biotech success isn’t just about great science—it’s about building a compelling commercial narrative from day one. Join us to explore how early commercialization planning, powered by real-world insights, can maximize an asset’s potential. Our discussion will uncover strategies to integrate commercial thinking into R&D. Register now. |
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| By Nick Paul Taylor The National Institutes of Health terminated $1.8 billion in grants in fewer than 40 days as part of a whirlwind of cuts early in the Trump administration, according to research published in JAMA. |
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By Nick Paul Taylor Sanofi has scrapped its collaboration with IGM Biosciences, eliminating the biotech’s last program in the process. IGM responded by laying off 80% of its staff and closing most of its lab and office facilities. |
By Gabrielle Masson Vir Biotechnology’s sidelined hepatitis B candidate, designed to serve as a “functional cure,” has failed to achieve the efficacy results hoped for in a midstage study. |
Sponsored by 89bio How a commonly “silent disease” is driving urgency and novelty in the liver disease treatment paradigm and what can we hope for. |
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No matter where you are in your biologics development journey, you need reliable, high-quality analytical data to move forward with confidence. Our full-spectrum analytical testing services are designed to meet your evolving needs, from early to late stage clinical and beyond. 
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By Darren Incorvaia Eli Lilly is investing more in its home state of Indiana, pumping up to $250 million more into an existing collaboration with Purdue University over the next eight years. |
By Nick Paul Taylor Leo Pharma has shared phase 2b data on its eczema prospect temtokibart, reporting that the top three doses of the IL-22RA1 blocker beat placebo on the primary endpoint. |
By Darren Incorvaia,Zoey Becker In the wake of the high-profile departure of Peter Marks, M.D., Ph.D., the FDA has a new leader for its Center for Biologics Evaluation and Research. FDA Commissioner Martin Makary, M.D., has named hematologist-oncologist Vinay Prasad, M.D., to the post. |
By Ben Adams Qilu Pharmaceutical is paying 280 million Chinese yuan ($38 million) for a licensing and collaboration deal with fellow China biopharma Minghui Pharmaceutical. |
By Darren Incorvaia The Food and Drug Administration is going all in on artificial intelligence. Commissioner Martin Makary, M.D., has instructed all the agency’s centers to fully integrate generative AI into their work by the end of June. |
By Conor Hale Jeremy Walsh was named head of IT and AI, according to his post on LinkedIn. |
By Gabrielle Masson,Darren Incorvaia As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team. |
By Ayla Ellison,Angus Liu This week on "The Top Line," Angela Hwang reflects on her leap from nearly 30 years at Pfizer to leading a biotech startup—and the career lessons that continue to guide her leadership and commitment to developing diverse talent. |
By Angus Liu Enhertu delivered a trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," Angela Hwang reflects on her leap from nearly 30 years at Pfizer to leading a biotech startup—and the career lessons that continue to guide her leadership and commitment to developing diverse talent. |
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Thursday, May 15, 2025 | 12pm ET / 9am PT Join this webinar for a deep dive into today’s biotech investment climate and practical strategies to navigate commercialization when pharma partnerships are delayed or uncertain. 
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Whitepaper Don’t delay your gene transfer trial’s start-up timeline by gaining the latest insights from WCG’s case study on the power of a seamless Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) review process. Sponsored by: WCG |
Whitepaper Learn how the SpyLock service can offer fast bispecific generation, reduce workload, and accelerate candidate selection. Sponsored by: Bio-Rad |
Whitepaper We interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
eBook Typical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic. Sponsored by: IQVIA |
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