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 Gives Green Light To Three New Products And A New Indication For Afinitor

This article was originally published in The Pink Sheet Daily

Executive Summary

The EU's CHMP gave positive opinions on three new products – Novartis' glycopyrronium, AstraZeneca's ceftaroline and Takeda's teduglutide – and on a major new indication for Novartis’ everolimus (Afinitor), after its meeting on June 18-21.

You may also be interested in...



Acacia Pharma Raises $23.5 M Series B For Repurposing Drugs As Anti-Emetics

Other product candidates in the cancer supportive care sector being developed by the U.K. virtual biotech include a liquid formulation of a muscarinic agonist for dry mouth and a megestrol/formoterol combination therapy for muscle wasting.

Despite Discount, High Price Again Fells Novartis’ Afinitor At NICE

Novartis’ discount for Afinitor in breast cancer has failed to convince NICE that the drug is cost-effective.

Novartis Once-Daily COPD Combo Safe, Effective And Ready For Filing – Everywhere But In The U.S.

Novartis released results from “an unprecedented package of data” to be filed with European regulators for its novel once-daily dual bronchodilator combination of the LABA indacaterol and the LAMA NVA237 (glycopyrronium) for COPD at the European Respiratory Society Congress, but FDA has already made clear that it wants to see trials with once- and twice-daily dosing at lower strengths than those tried in the European program, and those studies have yet to launch.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS074324

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