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

Amgen’s Breakthrough Blincyto Clears FDA At Breakneck Pace, But With REMS Attached

This article was originally published in The Pink Sheet Daily

Executive Summary

The big biotech’s blinatumomab gains accelerated approval to treat a rare form of ALL. The breakthrough therapy does have a REMS on serious risks and administration concerns.

You may also be interested in...



Amgen's Blincyto Adds Pediatric Claim For Leukemia

Study supporting accelerated approval for the leukemia drug satisfied an FDA written request under the Best Pharmaceuticals for Children Act.

R&D Briefs: Alprolix Approval Bodes Well, T-VEC Stumbles, Curis Back On Track

FDA approves Biogen’s long-acting hemophilia drug Alprolix and lifts clinical hold on Curis’ cancer drug CUDC-427, but Amgen’s announcement that its melanoma vaccine T-VEC failed to improve survival clouds its chances with the agency.

Is The Time Finally Right For Bispecific Antibodies?

Merck, Lilly, Gilead and Celgene are among the companies striking deals that involve bispecific antibodies. The novel dual-acting drugs have been in development since the 1980s with little success, yet big pharma believes they may finally be coming of age.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS076771

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel