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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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Today’s Big NewsMay 8, 2025 |
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These studies reveal a drug’s active free fraction, which impacts safety and efficacy. QPS experts explain the methods to determine plasma protein binding. Download the QPS white paper: Plasma Protein Binding 
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| By Fraiser Kansteiner GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease on Wednesday, but the May 7 deadline has come and gone without a decision from the U.S. regulator. The situation marks the latest in a string of missed deadlines by the FDA following mass job cuts under the Trump administration. |
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By Conor Hale Jeremy Walsh was named head of IT and AI, according to his post on LinkedIn. |
By Nick Paul Taylor Takeda has shot down candidates acquired in its $525 million Maverick Therapeutics takeover, blowing a hole in its oncology R&D pipeline in the process. The two terminations, coupled to the removal of a third asset, halved the number of cancer candidates in Takeda’s phase 1 and 2 pipeline. |
By Fraiser Kansteiner With Teva entering the next stage of its sweeping restructuring plan, thousands of employees are slated to be let go from the hybrid generics and innovative medicines giant. |
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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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By Darren Incorvaia Vor Bio is the latest cell therapy company to reach the end of the road. The biotech is immediately winding down clinical and manufacturing operations and laying off almost all staff. |
By Andrea Park Fresh off earning FDA approval for a prefilled syringe version of Vyvgart Hytrulo for at-home administration, argenx is building buzz with a new direct-to-consumer campaign. |
By Kevin Dunleavy After failing in his first term to install a most favored nation plan to reduce drug prices, President Donald Trump is at it again, trying to push through a policy to tie some drugs' prices with those from other high-income countries, according to Politico. |
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 Angus Liu The head of the FDA’s oncology department, Richard Pazdur, M.D., is now the only FDA center director left from the prior administration, so the biopharma industry will be looking eagerly for signs of policy consistency from the upcoming public meeting. |
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 Ben Adams Another Big Pharma is opening up its wallet to pour billions into its U.S. operations. |
By James Waldron California investment firm Vivo Capital has secured $740 million in commitments to be aimed at preclinical- and clinical-stage life sciences companies. |
By Nick Paul Taylor GSK has shared the data behind its phase 3 liver disease win, revealing patients on linerixibat reported reductions in itching that began after two weeks and persisted through the 24-week primary endpoint. |
By Zoey Becker The company has three key phase 3 readouts this year, which it hopes will contribute to long-term growth despite a flat outlook for 2025. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," hear how the founders of ElevAAte are turning shared East Asian American experiences into collective power for the next generation of biopharma leaders. |
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Tuesday, May 20, 2025 | 11am ET / 8am PT This webinar will feature industry experts discussing the power of combining biomedical data analysis with matched tissue and molecular samples. Register today to learn more. 
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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 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 |
Whitepaper Learn how the SpyLock service can offer fast bispecific generation, reduce workload, and accelerate candidate selection. Sponsored by: Bio-Rad |
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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