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’s Highly Anticipated Ocrelizumab Delayed By Manufacturing Issues

Executive Summary

US FDA extends review timeline for the multiple sclerosis BLA until March 28, 2017 to have time to review new information about commercial manufacturing process, Roche says.

You may also be interested in...



Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.

MS Drug Prices Far Exceed Value Thresholds, Even At Current Discounts – ICER Report

List pricing for Biogen’s Tecfidera and Novartis’ Gilenya would need to be discounted 47% and 50%, respectively, for them to be considered good values, ICER concludes in a new report. But three products come in under ICER's thresholds.

US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing

Tesaro’s IV formulation of Varubi draws letter keeping with last year’s emerging trend of manufacturing-related CRLs, in this case agency concerns about CMC data related to comparability of drug produced by two different contractors; issue seems unlikely to significantly delay approval of the new version of CINV drug, however.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS119712

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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