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Following Monday’s clinical defeat by Eli Lilly, Novo Nordisk cut the 2027 list prices for its three GLP-1 medicines by as much as 50%, while boasting Phase 2 data for its invesigational triple-G agonist.
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Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
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Read our takes on the biggest stories happening in the industry.
FDA
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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The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and discontinued partnerships.
The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year.
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative to conventional CRISPR. Clinical results have so far been promising.
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
Following challenges with its drug candidate bexotegrast and announcement of a limited-duration stockholder rights program, Pliant is paring back its workforce.
No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative medicines by 90% and mislead U.S. policymakers into thinking Americans are overpaying.
After multiple rounds of layoffs that cut Kronos down to just 10 people, the small molecule biotech has accepted a buyout offer from Kevin Tang’s Concentra Biosciences.
As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.