Wyeth’s Viviant “Approvable” For Osteoporosis
Analysis sought for treatment indication is similar to what FDA requested for prevention setting.
More from Archive
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.’
More from Pink Sheet
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.