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

Secura Bio, Inc.

https://securabio.com/

Latest From Secura Bio, Inc.

US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

Advisory Committees Post Market Regulation & Studies

Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions

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

US FDA Performance Tracker Approvals

PI3K Inhibitors For Hematology Indications Need Randomized Data, FDA Panel Says

Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.

Advisory Committees Drug Approval Standards

TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend

Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.

Advisory Committees Drug Safety
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Generic Drugs
UsernamePublicRestriction

Register