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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
Of the 11 companies participating in the spring cohorts of the Drive program run by MassBio and SCbio, eight have locations in Massachusetts. One cohort focuses on biotech and the other on biomarkers and diagnostics.
Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.
While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule approach.
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.
The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma. The biotech has now gone under.
Convergent Therapeutics’ Dr. Philip Kantoff and Plus Therapeutics’ Dr. Marc Hedrick discuss how unmet medical needs, maturing isotope supply chains and innovative delivery are positioning targeted radiation as oncology’s next big platform.
As AI reshapes deeply specialized scientific work, R&D professionals must learn to navigate the shift to a skills-centered market. The key is knowing which skills to develop and how to leverage AI as scientific modalities evolve, technologies advance and regulatory complexity increases.
Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
The recent uptick in IPOs is an encouraging signal after a drought for much of 2025. Experts point to AI as a driving force behind this resurgence.