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As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
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Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority 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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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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M&A was already on the upswing in 2024, and the new Trump administration may support that trend. But if data aren’t handled properly, acquisitions won’t reach their full potential.
With just one asset in weight loss moving through the clinic, Pfizer targets the space for potential dealmaking, as well as bringing assets over from China.
Senator Bill Cassidy voted with fellow Republicans on the Senate Finance Committee Tuesday morning to move forward the nomination of Robert F. Kennedy, Jr. for HHS secretary.
Just over a year after striking an obesity deal with Novo Nordisk, an SEC filing shows Flagship Pioneering spinout Omega Therapeutics is days away from bankruptcy and will lay off up to 17 employees.
Merck reported a 2% decline in Gardasil sales, after reaching a peak of $8.9 billion in 2023. Now with shipments to China paused, the HPV vaccine faces significant headwinds going into 2025.
Despite lackluster sales of Eylea’s high-dose formulation and Sanofi-partnered Dupixent, Regeneron beat Q4 forecasts overall thanks in part to cancer therapy Libtayo and gave shareholders a cut of the profits for the first time in the company’s long history.
The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades.
Amid growing concern of the overuse and misuse of obesity drugs, the UK’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro.
The Massachusetts-based biotech plans to use the funds to push its candidates into mid-stage clinical trials in a space dominated by Vertex.
In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.