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


Genentech/OSI Tarceva sNDA

Executive Summary

FDA's Oncologic Drugs Advisory Committee will review on Sept. 13 Genentech/OSI's Tarceva sNDA (21-743/S003) for first-line treatment, in combination with gemcitabine (Lilly's Gemzar), of patients with locally advanced, unresectable or metastatic pancreatic cancer. The estimated user fee deadline for the sNDA is Nov. 2. Tarceva (erlotinib) was approved in November 2004 for locally advanced or metastatic non-small cell lung cancer (1"The Pink Sheet" Nov. 29, 2004, p. 4). The meeting will be at the Holiday Inn in Bethesda, Md. at 8 a.m. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit]...

You may also be interested in...

OSI Joins Genentech In Eye Disease Market With $935 Mil. Eyetech Purchase

OSI Pharmaceuticals' existing partnership with Genentech will be unaffected by the firm's acquisition of Eyetech Pharmaceuticals, CEO Colin Goddard assured investors Aug. 22

'Touchless Plants' To Virtually Trained Workforces - Indian Cos Share Digitalization Tips

Despite AI and digital analytics playing an increasing role in pharma, the industry lags others globally, a recent event heard. Meanwhile, top Indian players including Sun Pharma, Cipla and others shared what is driving their initiatives, ranging from a 'touchless factory' to virtual training and lessons learned along the way.

More IVD Mergers: Agilent Buys Resolution, Hologic Acquires Diagenode

Hologic made its third big acquisition of 2021 and Agilent agreed to pay up to $695m for Resolution Bioscience to extend its precision oncology capabilities.





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