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
UsernamePublicRestriction

Roche and FDA in Oncology: Fighting in Public, Collaboarting in Private

This article was originally published in RPM Report

You may also be interested in...



Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations

Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.

Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination

Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.

Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS

Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.

Related Content

UsernamePublicRestriction

Register

PS080896

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