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The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.
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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.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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The FDA previously refused to review Biohaven’s candidate in the indication due to a failed late-stage trial. However, the company is now planning to file an NDA in the fourth quarter of 2024.
Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
Stifel analyst Paul Matteis called Tuesday’s readout a “positive surprise” that could reinvigorate some investor enthusiasm for Biogen as the company “has essentially become an out-of-favor value stock,” driven by the slow launch of its Alzheimer’s disease therapy Leqembi.
As technology continues to evolve, companies should have strategies that incorporate an understand of where they are now, where they want to be, and do they have the talent to get there.
In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively.
Regulators, policymakers and others can more effectively battle the disease by creating incentives to make mpox a more attractive investment opportunity.
Before companies and investors look towards the future, they must first understand the opportunities and challenges AI presents to them. From the benefits included in advancing processes to cybersecurity hazards, AI innovation is a balanced scale of oppportunities and risks.
Athira Pharma will cut about 49 positions, including two people in the C-suite. The announcement follows the company’s disappointing results for its investigational Alzheimer’s therapy.
Bristol Myers Squibb is continuing its cost-savings measures with layoffs in Lawrenceville, New Jersey. The company announced earlier this year that it will eliminate 2,200 jobs by the end of 2024 in a bid to save $1.5 billion through 2025.
Monday’s failure to improve overall survival in breast cancer “further dents belief” in the companies’ Dato-DXd and “likely complicates regulatory discussions for approval of this indication,” Jefferies analyst Peter Welford wrote in a note to investors.