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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.
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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.
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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Read our takes on the biggest stories happening in the industry.
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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Strong growth in immunology and neurology prompted AbbVie to raise its 2026 outlook and consider future M&A from a position of “ample financial capacity.”
Biogen’s growth was expected to stay flat through the 2030s. A key acquisition and busy late-stage pipeline have relieved the pressure and cleared the way for some early-stage bets, CEO Chris Viehbacher said Wednesday.
Regeneron hauled in $3.6 billion during the first quarter of 2026, as analysts homed in on a slight Eylea HD miss and key upcoming readouts, including for LAG3 candidate fianlimab in metastatic melanoma.
Key dosing differences between Eli Lilly’s Kisunla and Biogen’s Leqembi are about to come to a head in the Alzheimer’s market as patients end their 18-month course of Lilly’s product.
Chiesi Group is taking KalVista Pharmaceuticals under its wing, paying $1.9 billion for the biotech’s oral therapy Ekterly to treat severe swelling episodes caused by the rare genetic disorder hereditary angioedema.
After a quarter in which sales topped $15 billion and key readouts went AstraZeneca’s way, the company is increasingly confident that its 2030 revenue target is in reach.
While sales for most of GSK’s shots slumped as vaccine skepticism continues to climb in the U.S., Shingrix jumped 20% to almost $1.4 billion in the first quarter, emerging as the pharma’s top-selling product.
The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year.
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
Analysts will be watching as a generic version of semaglutide—marketed by Novo Nordisk as Wegovy for weight loss—launches in Canada as a test case for future price erosion in the U.S.