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

EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin

Executive Summary

A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a potential multiple myeloma therapy derived from sea squirts.

Advertisement

Related Content

Think Positive: Clovis Confident Of CHMP Okay For Rubraca
Decision Time At CHMP: Portola and Aegerion In Spotlight
Bumper Number Of 'Oral Explanations' Due At CHMP Meeting
CHMP Negative On PharmaMar's Aplidin In Multiple Myeloma
Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies
Samsung's Ontruzant Becomes First Trastuzumab Biosimilar Approved In EU
CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin
EU Paediatric Regulation Report ‘Positive,’ But More Investigation Needed, Legal Expert Claims
Roche Set For Disruptive Entry To MS Market With 'Brave' Ocrevus Pricing Strategy
MedDay Raises €34m For US Trial As EU Filing Of MS Drug Nears

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS122158

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