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Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.
Biopharma manufacturers, payers and other stakeholders strongly support changing an Obama-era policy for reimbursing biosimilars under Medicare Part B in comments to the Centers for Medicare and Medicaid Services.
Allergan proudly describes itself as a 'bold' company, and its latest move to protect its Restasis franchise certainly qualifies as a reason why. But Allergan’s unlikely position as the industry’s self-appointed leader in social responsibility should make the rest of the industry cringe.
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Greg Nulty, CFO, VP & CFO, NA
Peter Goldschmidt, Pres.
Patrick Genestin, VP, Bus. Dev. & Licensing
Carlos Sattler, MD, VP, Clin. Dev. & Medical Affairs
Scott Smith, VP, Commercial Operations, US
Anthony Maffia, III, VP, Regulatory Affairs
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