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

Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps

Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.

Legislation Review Pathway

Oncopeptides Weighing Pepaxto Withdrawal Request

Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.

Review Pathway Drug Approval Standards

GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.

Review Pathway Post Market Regulation & Studies

One More Message From Makena: Fighting US FDA Can Pay Off

The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.

Advisory Committees Commercial
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
UsernamePublicRestriction

Register