Pink Sheet 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

EU Decision Thwarts Novartis's Near-Term Piqray Ambitions

Company Has Pulled Its UK HTA Submission

Executive Summary

Novartis seems to have accepted the fact that the indication granted for Piqray in the EU means there is little scope for the advanced breast cancer drug to be used in markets such as the UK.

You may also be interested in...



EU Indication Restricted For Novartis's Newly Approved Piqray

Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.

Rhythm’s Setmelanotide Loses Fast-Track Status In Europe

The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.

Santhera Pulls EU Filing For Failed DMD Candidate

Swiss company Santhera's lengthy and problem-laden journey to repurpose its already marketed idebenone for use in Duchenne Muscular Dystrophy has ended in failure. The company has withdrawn its EU filing for the product following its announcement that it was halting development.

Topics

UsernamePublicRestriction

Register

OM001644

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