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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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A federal judge ruled last week that the U.S. government can use its economic standing as a bulk purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act.
The U.K.-based biotech is the latest to cash in on the hot antibody-drug conjugate space, closing a $115.5 million Series A round co-led by Novo Holdings and participation from Eli Lilly.
Patient assistance programs may actually be a two-way street, providing patients with drugs and companies with data.
The blood plasma pharma is considering a buyout offer from the founding family and asset manager Brookfield, which would delist the company from the Spanish and Nasdaq markets.
Eli Lilly on Monday announced a $3.2 billion all-cash deal to purchase Morphic and its pipeline of oral integrin therapies in a move to expand the pharma’s presence in the autoimmune diseases space.
Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.
Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues.
Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.
President Joe Biden and Sen. Bernie Sanders in a Tuesday op-ed in USA Today called on Novo Nordisk and Eli Lilly to “stop ripping off Americans” with “unconscionably high prices” for their GLP-1 medicines.
Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.