Time Waits for No Lab, Ranbaxy Learns
Time waits for no lab learn Ranbaxy and new owner Daiichi Sankyo as stock sinks after FDA sanctions firm for holding stability testing samples in refrigerators until its overworked lab could get around to testing them. Lab was backdating same-day testing of 30-, 60- and 90-day samples, FDA said as it slapped Ranbaxy with application integrity letter.
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
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.