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Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.
Follow along as BioSpace tracks job cuts and restructuring initiatives throughout 2025.
A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.
It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.
Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.
In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.
For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.
Move over Humira, Skyrizi and Rinvoq are expected to beat the former megablockbuster’s peak sales by the end of this year.