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

Tysabri for Crohn’s gets FDA advisory review

Executive Summary

FDA's Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees will jointly review Biogen Idec/Elan's Tysabri (natalizumab) for moderately to severely active Crohn's disease July 31. Indicated for multiple sclerosis, Tysabri's sNDA includes results of three trials assessing the biologic as both an induction and maintenance therapy. Biogen pulled Tysabri from the market in 2005 after reports of progressive multifocal leukoencephalopathy, and the company is now in the second phase of the drug's relaunch. One of the three reported cases of PML in the Tysabri database was in a Crohn's patient...

You may also be interested in...



Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?

“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”

UsernamePublicRestriction

Register

LL1135972

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