In Vivo 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

Satraplatin's Stumble: Is Accelerated Approval Under Threat?

Executive Summary

It was a shocking summer for Germany's GPC Biotech, whose stock lost over 70% of its value in late July after an FDA advisory committee recommended that FDA delay considering prostate cancer candidate satraplatin for approval. Regulatory snafus are nothing new, but this story sends some clear messages to the industry.

You may also be interested in...



Phase III Prostate Cancer Failures: Taxotere to Blame?

Had a Phase III failure? Don't believe the data. Trial design, concurrent therapies, patient selection, or even the conventional diagnostic indicator for the disease could be at fault, as illustrated by a handful of late-stage trip-ups during 2007.

Phase III Prostate Cancer Failures: Taxotere to Blame?

Had a Phase III failure? Don't believe the data. Trial design, concurrent therapies, patient selection, or even the conventional diagnostic indicator for the disease could be at fault, as illustrated by a handful of late-stage trip-ups during 2007.

Europe's New Spec Pharma Models

Spec pharma has created significant value in the US, but not, so far, in Europe. Still, Europe's spec pharma hopefuls aren't giving up, and they're trying out variations on the theme--some starting with infrastructure, others with products.

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

ID1125347

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