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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.
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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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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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For an investment of up to $1.9 billion, Eli Lilly will be able to use Ascidian Therapeutics’ platform that removes mutated exons from mRNA molecules, avoiding the expression of disease-causing proteins.
Improved survival on display at the American Society of Clinical Oncology (ASCO) in Chicago; Pfizer’s unusual pact with China’s Innovent highlights a new type of collaboration; Eli Lilly continues its nonstop deal streak, including with Chinese biotechs; and looking ahead to this weekend’s American Diabetes Association meeting.
From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace’s NextGen Class of 2026 told us about the issues keeping them up at night.
Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
The forecast makes pharma one of the fastest-growing manufacturing industries in the U.S.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say.
Eli Lilly and the Haisco Pharmaceutical Group have yet to disclose what specific indications they plan to prioritize.
When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.
Recent deals from Pfizer and Bristol Myers Squibb hint at Big Pharma’s more collaborative approach to partnering with Chinese companies.