Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Advisory Committee Splits The Difference On CABP Trials
A fierce dispute between researchers and clinicians who think community-acquired bacterial pneumonia drugs should be evaluated by their effect on mortality, and those who favor symptom-based evaluation, is unlikely to be quelled by actions taken at the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee, which gave each side some of what it wanted
More from Archive
• By
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.
• By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
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.
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
• By
In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.
• By
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
• By
Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.