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Approvals Biosimilars Drug Approval Standards

Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Coherus Gets Goal Date On US Adalimumab Biosimilar

A further FDA approval for a biosimilar to Humira could be on the cards, after Coherus revealed the agency’s goal date for its CHS-1420 adalimumab application.

Bio-Thera Follows EU Bevacizumab Biosimilar Filing With FDA Goal Date

China’s Bio-Thera is continuing its journey to bring biosimilars to patients across the globe, with its BAT1706 biosimilar bevacizumab candidate accepted for filing by the US Food and Drug Administration.

Amneal Takes Control Of Kashiv Specialty In $100m+ Deal

Amneal will take a majority stake in Kashiv Specialty Pharmaceuticals after striking a deal worth potentially more than $100m for a 98% stake in the hybrid 505(b)(2) and complex generics specialist.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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