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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Alpharma has withdrawn its NDA for Embeda, its extended-release painkiller.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...
Tags: priority   alpharma   Embeda   FDA   painkiller   Phase III  

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...
Tags: FDA   Schering Plough   priority  

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).

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Tags: priority   doctors   physicians  

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