Scrip 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

Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

FDA Concerned About High Dose And Testicular Side Effects

Executive Summary

Complete Response Letter is a major setback for Gilead and its partner Galapagos.

You may also be interested in...



Galapagos CEO Upbeat Despite Filgotinib Upset In US

Onno van de Stolpe has told Scrip it will take time to win investor confidence back after more disappointing news about the JAK inhibitor but Galapagos has "the pipeline and the cash in the organization to do so."

Gilead Gives Up On Galapagos's Filgotinib In RA

A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.

Galapagos Sells CRO To Selvita For €31.2m

The Belgian biotech has divested its drug discovery services unit in Croatia which was making a nice profit but was not a priority as Galapagos concentrates on setting up its commercial operations in Europe.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132542

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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