FDA’s review of AstraZeneca’s platelet inhibitor ticagrelor was tinged by the agency’s earlier evaluation and delayed approval of Lilly/Daiichi’s prasugrel for acute coronary syndromes.
FDA’s evaluation of AstraZeneca PLC’s platelet inhibitor Brilinta (ticagrelor) was tinged by the agency’s prior review experience with Eli Lilly & Co./Daiichi Sankyo Co. Ltd.’s competing P2Y12 antagonist Effient (prasugrel) for acute coronary syndromes.
Shades of the prasugrel regulatory experience peek through in various places of the ticagrelor review, agency documents show. Among the...
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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
