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Latest From C.R. Bard
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.
Regeneron Proves Insurmountable As Second FDA Approved Eylea Biosimilar Blocked
Regeneron’s lynchpin US formulation patent for its Eylea 2mg appears to remain a thorn in the side for biosimilar sponsors, as Samsung Bioepis joins Biocon in being blocked from launching its US FDA-approved biosimilar to the near $6bn eye-disease biologic.
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- Davol, Inc.
- Embo Medical Limited
- Liberator Medical, Inc.
- Lutonix, Inc.
- Medafor, Inc.
- Medicon, Inc.
- Neomend, Inc.
- Rochester Medical, Inc.
- Vascular Pathways, Inc.
- FlowCardia, Inc.
- Bridger Biomed, Inc.
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