Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 Seeks To Knock Out Humira Patents Through IPR Process

This article was originally published in The Pink Sheet Daily

Executive Summary

Biosimilar sponsors are taking a shine to PTO’s new patent challenge proceedings.

You may also be interested in...



Biosimilar Pathway Quickly Becoming Crowded In U.S.

Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.

US FDA’s Remote Evaluations Of Drug Manufacturing Facilities May Become Public

Agency is considering posting its observations from remote assessments of facilities, assistant commissioner Miller tells annual FDLI meeting; new FDA Inspectional Activities Council will develop an action plan for the agency’s inspections program.

Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?

After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.

Topics

Related Companies

UsernamePublicRestriction

Register

PS078636

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