Scrip 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

European Approval Recommendation Delayed Again For Roche’s Ocrevus

Executive Summary

No European approval recommendation for Roche multiple sclerosis drug Ocrevus but the Swiss major tells Scrip it is hopeful of getting approval within four months.

You may also be interested in...



EU CHMP OKs New Treatments For MS, Esophagitis, CMV, Hemophilia – & First Biosimilar Avastin

The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.

Multiple Sclerosis Drug Price Increases Probed By House Oversight Panel Democrats

Reps. Cummings and Welch contact seven manufacturers of multiple sclerosis drugs with inquiries about persistent and significant annual price increases. The members suggest some firms are boosting prices in "lockstep."

Genentech's Ocrevus Manufacturing Process Still A Work In Progress

Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132679

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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