FDA releases briefing documents and committee roster
The FDA incompletely scrubbed redacted text from its briefing document
The FDA rescrubs the briefing document. The original document is still available on CardioBrief.
Sanjay Kaul removed from FDA advisory panel
The Wall Street Journal Health Blog: Prasugrel Review Proceeds Without Key Safety Experts
FDA advisory panel recommends approval of prasugrel
Complete coverage of advisory hearing in heartwire
Victor Serebruany criticizes FDA hearing
CardioBrief Editorial: the incompetence of the FDA
Inside Indiana Business writes about the post-meeting discussions between Lilly and FDA
FDA provides “explanation” for Sanjay Kaul’s absence
Heartwire story provides most detailed account yet of prasugrel hearing
FDA offers more detailed explnation for Kaul’s absence on prasugrel committee
Heartwire: “Mistakes” made: FDA acknowledges Lilly phoned to question Sanjay Kaul’s inclusion on prasugrel panel
Wall Street Journal: Prasugrel gains European approval
CardioBrief: Prasugrel gains European approval
February 24-25 Lilly contact to FDA widely reported in the mainstream press and the blogosphere:
CardioBrief Transcript of FDA February 23 News Conference on prasugrel advisory panel
Reuters article by Susan Heavey reports 2 congressional inquiries
February 28 – March 3
Indianapolis Star reports prasugrel may be delayed due to congressional inquiry
Cowen & Co analysts downgrade Lilly on a clouded view for prasugrel
New York Times summarizes the prasugrel situation
CardioBrief comments on the possible prasugrel delay
FDA posts transcript and minutes of prasugrel advisory committee meeting
Prasugrel makes worldwide debut in United Kingdom
Prasugrel not affected by common CYP genetic variations
Serebruany and Wolfe ask FDA to halt review of prasugrel
UK’s NICE favors restricted approval for prasugrel
What do FDA insiders really think of prasugrel?
Lilly responds to Serebruany attack on TRITON-TIMI 38
FDA official defends integrity of prasugrel review
Congressman: FDA admits Kaul should not have been dismissed from prasugrel panel
FDA approves prasugrel!
July 14, 2009
Prasugrel approval aftermath: now the real battle begins
July 15, 2009
Deepak Bhatt editorial in NEJM: “Prasugrel in Clinical Practice.“
NEJM: Bhatt editorial evaluates prasugrel in clinical practice (CardioBrief story)
Lilly To Price Effient 18% Higher Than Plavix In US (Dow Jones newswire story by Peter Loftus)
Prasugrel priced 18% more than clopidogrel in US by Lilly/Daiichi Sankyo (CardioBrief)
July 31, 2009
The In Vivo Blog: The Effient Launch: Cracking the Door to Primary-Care Marketing
August 5, 2009
Prasugrel finally hits the street
August 10, 2009
30 days after prasugrel approval FDA releases some briefing documents. (You can access all the FDA documents by clicking on this link and searching for “prasugrel.” Or you can click on this link, which links to most of the same documents but does not include links to the Medication Guide or the REMS (Risk Evaluation and Mitigation Strategy) document.
“This has not been a well managed review process” –FDA official on prasugrel approval (CardioBrief, August 11)
September 2, 2009
FDA official reviews his own prasugrel review in NEJM
September 11, 2009
Reuters story by Brendan Borrell on prasugrel ghostwriter
CardioBrief: Editor insists prasugrel ghostwriter go public
Scott Hensley’s article in the NPR Health blog.
September 21, 2009
Wall Street analyst calls prasugrel launch “muted”
October 5, 2009
FDA posts full drug approval package for prasugrel
October 20, 2009
Medco launches 14,000 patient head-to-head comparison of clopidogrel and prasugrel
October 28, 2009
UK’s NICE allows limited use of prasugrel
Click here to read a PharmaTimes story by Selina McKee.
Click here for the NICE page with links to the guidance documents.
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