Latest from Manas Mishra
The deal, which could be worth over $2bn, looks to bolster Gilead's growing immunology franchise while also granting long-time partner Galapagos a chance at a future royalty stream.
Artificial intelligence in pharmaceutical manufacturing is increasing in prevalence, offering a unique opportunity for global regulators to align on expectations, industry group IFPMA says.
The draft report lays out a unified EU framework to reduce disparities and modernize rare disease diagnosis, treatment, care and research.
The FDA's widely referenced scale-up and post-approval changes (SUPAC) guidelines could be modernized to acknowledge evolving science and conflicts with newer recommendations.
Just a month after sending Novo Nordisk a warning over an ad for its Wegovy pill, the US FDA has sent another warning raising concerns over the firm’s safety reporting compliance.
Povetacicept’s Phase III results strengthen Vertex’s push to expand beyond cystic fibrosis, with the company expected to complete the drug’s rolling submission by the end of March.
