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

Pfizer Halts Phase III Figitumumab Trial In NSCLC But Forges On With Other Studies

This article was originally published in The Pink Sheet Daily

Executive Summary

Insulin growth factor-1 receptor inhibitor is one of Pfizer's lead oncology candidates, but the company is not throwing in the towel on figitumumab yet.

You may also be interested in...



Amgen Rethinks Ganitumab After Longshot Pancreatic Cancer Trial Fails

Hopes for IGF-1R inhibitor ganitumab had not been high due to past flops for others in the class. But research in extensive stage small-cell lung cancer and KRAS wild-type metastatic colorectal cancer goes on, at least for now.

In Brief

Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11

In Brief

Further delay for Prevnar 13: FDA has not yet completed its review of Pfizer's Prevnar 13 vaccine for pneumococcal disease and therefore the review will continue beyond the Dec. 30 user fee deadline. It's not clear how much longer the review will take and there was no explanation for the delay, but there was no indication that additional information was sought, according to the drug maker's Dec. 30 statement. The vaccine is under priority review and FDA already used its one-time extension of the user fee period to move the original action date of Sept. 30 to the December date, after additional manufacturing data was submitted. An FDA advisory committee voted 10 to 1 on Nov. 18 to recommend the product, although the panel did not endorse a broad claim for otitis media (1"The Pink Sheet," Nov. 23, 2009). European marketing authorization was granted on Dec. 11

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

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

Cancel