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Latest From C.R. Bard
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.
More Stelara Biosimilars Line Up For Launch In US And EU
Samsung Bioepis and partner Sandoz have won approval for a third US Stelara biosimilar. Meanwhile, in Europe Celltrion has become the latest firm to qualify for an ustekinumab marketing authorization.
CalciMedica Eyes Success In Pancreatitis, Acute Kidney Injury
Phase IIb data for Auxora in an acute pancreatitis subpopulation is expected to set up the CRAC channel inhibitor for Phase III in that indication while suggesting positive read-through for AKI.
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