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

Novartis Faces The Music Over EU Piqray Review

Green Light Possible At EMA But Scrutiny Continues

Executive Summary

Novartis is hoping to address EU regulators’ concerns regarding Piqray and to persuade them that the new advanced breast cancer treatment is fit for approval.

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.

EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen

The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.

Crunch Time At EMA For Luspatercept And Glasdegib

Eight new marketing applications including ones from BMS/Acceleron Pharma and Pfizer are up for an opinion at the April meeting of the European Medicines Agency’s drug evaluation committee, the CHMP.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS142106

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