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Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

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.

Performance Tracker Drug Review

Biosimilar User Fees Discounted To Begin Second Round

After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.

Biosimilars Review Pathway

Medicare Coding Change For Biosimilars Could Save $65bn, Firms Say

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.

Biosimilars Medicare

Too Bold By Half: Allergan’s Latest Moves And Pharma’s Leadership Deficit

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.

Business Strategies Intellectual Property
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