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


FDA Starts Its Second Safety Investigation Into Novartis/Orion's Parkinson's Drug Stalevo

This article was originally published in The Pink Sheet Daily

Executive Summary

An FDA meta-analysis reveals a cardiovascular safety risk with Orion and Novartis' Stalevo, on top of an ongoing review of a prostate cancer imbalance, but uncertainty about the data raises the question of whether FDA will want a prospective heart safety study.

You may also be interested in...

Mini-Sentinel Project Will Evaluate Impact Of LABA Label Change

The Mini-Sentinel medical products safety surveillance project will assess the health impact of FDA-mandated label warnings for use of long-acting beta agonists in asthma, Harvard Pilgrim Health Care Institute’s Richard Platt noted during a Sept. 15 webinar on Mini-Sentinel sponsored by the Brookings Institution.

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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