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Latest From Proximagen Group plc

Was Apokyn Safety Update A Missed Opportunity For Supernus To Hold Off Generic Refill Cartridge?

US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.

Generic Drugs Review Pathway

Finance Watch: Atlas Raises $450m Venture Fund For Biotech Breakthroughs

Both Atlas and Foresite Capital announced new funds focused on start-ups. Also, Flagship launched Vesalius with $75m in initial funding, Innoviva sold $225m in notes, Hookipa priced a $75m follow-on offering and job cuts were revealed by Epizyme, Flexion, Deciphera and Gemini. 

Financing Innovation

US FDA Approval Actions To Watch Out For In June

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

Drug Review Drug Approval Standards

Keeping Track: Industry Channels Inner Gottlieb As Commissioner Departs US FDA

The latest drug development news and highlights from our US FDA Performance Tracker.

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Company Information

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  • Pharmaceuticals
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • Cambridge Biotechnology Ltd (CBT)
    • Minster Pharmaceuticals
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