Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

EU's CHMP OKs Major New Uses for Hemlibra, Praluent, Forxiga – And More

Executive Summary

Several major products have been recommended for wider indications in the EU, including Roche’s hemophilia drug Hemlibra, Sanofi’s Praluent in atherosclerotic disease, and AstraZeneca’s Forxiga for type 1 diabetes.

You may also be interested in...



European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

New Products Soar And Old Stand Their Ground As Roche Heads Off Biosimilar Threat

New products helped Roche to 7% sales growth in 2018 but the outlook for 2019 is lower as the biosimilar headwinds start to blow from the US.

AZ Sees A Future For Forxiga In Type 1 Diabetes

The EMA is looking at a marketing authorization variation for the type 2 diabetes blockbuster SGLT-2 inhibitor for use as an oral adjunct treatment to insulin in adults with type 1. Observers will be interested to see what stance the agency takes on the slightly higher number of diabetic ketoacidosis events seen in trials supporting the submission.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124693

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