Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Printed By

UsernamePublicRestriction

Latest From Alkermes plc

Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

Post Market Regulation & Studies Review Pathway

Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

Post Market Regulation & Studies Review Pathway

Amgen Lays Out Plans For Rare Disease Portfolio Growth

Amgen detailed plans for increasing sales of drugs acquired in its Horizon transaction and outlined growth opportunities in its R&D pipeline during a rare disease showcase. 

Rare Diseases Strategy

OTC Naloxone Pioneer Emergent BioSolutions Puts Papa At Helm As It Navigates Strategy Shift

Like his previous move, Papa joins a pharma firm making a significant organizational shift to cut costs and increase revenues after extended period of higher spending and slowing income.

Executive Changes OTC Drugs
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Rodin Therapeutics, Inc.
UsernamePublicRestriction

Register