FDA’s June Avastin hearing featured a number of points of clear disconnect between the sponsor, the agency, and other stakeholders debating the role of the therapy for metastatic breast cancer. Perhaps the biggest: the most important issue may depend on a completely different agency, CMS.
Michael McCaughan
July 29, 2011
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
