prasugrel news from FierceBiotech
NewsBiopharma sees tougher FDA approval process
The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once Read more...
FDA delays review of Eli Lilly’s would-be blockbuster
Shares of Eli Lilly slipped slightly after the FDA announced that it would extend its review of the closely watched anti-clotting drug prasugrel by three months. Daiichi Sankyo and Lilly both believe Read more...
Prasugrel gets priority review
The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. The NDA for prasugrel was submitted to the agency in December. Now the drugmakers can expect an Read more...
Lilly submits prasugrel NDA
Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. Read more...
Lilly drug outperforms Plavix, but there's a catch
Eli Lilly's shot at a blockbuster heart drug was in question this morning after researchers unveiled new data showing that prasugrel outperformed a top competitor in the anti-clotting market while Read more...
Lilly suspends dosing in crucial drug trial
Eli Lilly and its partner Daiichi Sankyo moved swiftly to try and contain any damage from the news that Read more...
| Press ReleasesDaiichi Sankyo, Lilly Submit NDA for Investigational Antiplatelet Drug, Prasugrel, to FDA Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration If Approved for Marketing in the United States, Trade Name Read more... PRESS RELEASE: In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack Investigational compound reduces risk of major cardiovascular events by 19 Read more... |
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