Pink Sheet is part of the Business Intelligence Division 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.

Advertisement

Related Content

Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval
MS Drug Prices Far Exceed Value Thresholds, Even At Current Discounts – ICER Report
US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing
US FDA Has Slim Advisory Committee Schedule – A Sign Of Things Not To Come?
Keeping Track: US FDA Approves Spinraza And Rubraca, Delays Ocrevus; Plus Submissions Galore
Manufacturing Problems Aren't Rising, But It Was A Hot July
Roche's Ocrelizumab Strengthens Lead In Primary Progressive MS
Roche’s Ocrelizumab Poised To Seize Primary Progressive MS Opportunity

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS119712

Ask The Analyst

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

All set! This Question has been sent to 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