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Latest From C.R. Bard
New Drugs For Gastric Cancer, Liver Disease Among 14 Products Heading For EU Approval
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.
Second European Stelara Biosimilar Pits Sandoz Against Stada
Just days after the first European ustekinumab biosimilar launch, Sandoz has entered the fray with the second rival to Stelara, introducing its Samsung Bioepis-partnered Pyzchiva version to compete with Stada and Alvotech’s Uzpruvo.
Samsung Snags Second Soliris Biosimilar In US
Samsung Bioepis has received US FDA approval for its Epysqli eculizumab biosimilar to Soliris, only the second version to be authorized in the US. However, the company declined to comment on launch plans as litigation with originator Alexion remains ongoing.
Regulatory Recap: FDA’s Rx Advertising Draft Needs A Stronger Voice, Say Commentators
Generics Bulletin recaps the most recent regulatory news and updates from the FDA.
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