priority news from FierceBiotech
News
Committee votes to back GSK/Ligand's Promacta
GlaxoSmithKline and Ligand Pharmaceuticals won a key endorsement for Promacta for the short-term treatment of people with chronic immune thrombocytopenic purpura, or ITP. An FDA expert committee Read more...
Talecris' antibody drug gets priority review
The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains Read more...
Alpharma withdraws painkiller NDA
Alpharma has withdrawn its NDA for Embeda, its extended-release painkiller. While the company's drug qualified for priority review, Alpharma said that "certain technical issues around data Read more...
Celgene CEO outlines future plans, post-Pharmion buyout
In an interview with the Star-Ledger, Celgene CEO Sol Barer laid out some of the basics in how it will integrate operations with Pharmion, a biotech Celgene paid $2.9 billion for. After some 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...
FDA to give Schering program priority review
Schering-Plough says the FDA will provide a priority review for sugammadex, which is being Read more...
AEterna gets its ducks in a row
Executives at AEterna Zentaris have taken a good, long look at the company's pipeline and operations and have identified a number of changes that will take place. Cetrorelix, currently in a Phase Read more...
Antisoma drug flunks ovarian cancer trial
The UK's Antisoma says that its experimental therapy for ovarian cancer has failed a clinical trial, triggering a swift loss of about one fifth of the company's share value. The mid-stage trial of Read more...
GAO: Improvements Needed in FDA’s oversight of Direct-to-Consumer Advertising
Drug company spending on DTC advertising—-such as that on television and in magazines-—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. Over this period, drug companies spent less each year on DTC advertising ($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in 2005) or research and development ($31.4 billion in 2005).
Read more...SPOTLIGHT: Tykerb gains priority review
Analysts applauded today's announcement that the FDA will provide a priority review for GlaxoSmithKline's cancer therapy Tykerb. Report
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