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

Prexige “not approvable”

Executive Summary

Novartis receives a "not approvable" letter from FDA for its COX-2 inhibitor lumiracoxib for osteoarthritic pain, firm announces Sept. 27. The negative outcome is not unexpected as CEO Daniel Vasella previously told analysts, "I don't think we will get an approval" (1"The Pink Sheet" Sept. 17, 2007, p. 11). Novartis is not completely abandoning hope that Prexige could be approved for specific populations, such as patients with a higher incidence of gastrointestinal complications, including those suffering from ulcers or being treated with anticoagulants...

You may also be interested in...



Another setback for Prexige

The U.K., Germany and Austria pull Novartis' Prexige (lumiracoxib) from the market after the European Medicines Agency's Committee for Medicinal Products for Human Use initiates a safety review of the COX-2 inhibitor on Nov. 16. The drug was deemed "not approvable" in the U.S. by FDA in September (1"The Pink Sheet" Oct. 1, 2007, In Brief). An assessment from the CHMP is expected in December...

Novartis Oncology Pipeline Has Three Potential Blockbusters In The Offing

Novartis is aiming to launch a trio of potential blockbuster oncology drugs in the next few years that the firm hopes will erase the memory of several recent high-profile setbacks in multiple therapeutic areas

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.

UsernamePublicRestriction

Register

LL1134940

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