ImClone wants even broader Erbitux use; Astra's Iressa poised for gains

> AstraZeneca's lung cancer drug Iressa is poised to gain market share on new research showing the drug works better than standard chemo in many patients, a new report from Cutting Edge Information concludes. Release

> Cubist Pharmaceuticals saw its shares sink Monday on concerns about patent protection for its antibiotic Cubicin, which provides almost all of the company's revenue. Report

> A proposed overhaul of rules governing the European Union's pharmaceutical industry no longer includes a ban on repackaging prescription drugs for resale. Report

> Warner Chilcott said it received notice that Mylan Pharmaceuticals and Mutual Pharmaceutical have asked the FDA to approve generic versions of Warner's antibiotic Doryx. Release

> Cambridge Laboratories got the nod from Spanish regulators for its Huntington's disease treatment Nitoman (tetrabenazine), which will be marketed in that country by UCB. Report

> Merck Serono got European Commission approval to market Kuvan as a treatment for hyperphenylalaninemia. Release

> Norgine licensed its colonoscopy-prep drug Moviprep to Medical Futures for marketing in Canada. Report

> Anyone looking for a tough assessment of the world of drug development today should check out the Wall Street Journal's interview with Roche CEO Severin Schwan (photo). Report

> Emisphere Technologies says it will close its facility in Tarrytown, NY, relocate key workers to Cedar Knolls, NJ, and terminate staff as it joins the ranks of developers downsizing in the face of a severe economic crisis. Report

> Three weeks after reeling in a $19 million venture round, Ascent Therapeutics announced a licensing option deal through the Novartis Option Fund worth up to $200 million in fees and milestones. Report

> Osiris Therapeutics has hit a notable milestone, completing enrollment for a late-stage stem cell trial. Researchers will explore the benefits of Prochymal for steroid-refractory acute Graft versus Host Disease, a complication of bone marrow transplantation. Report

> AstraZeneca and Bristol-Myers Squibb are expanding their collaboration on a new type 2 diabetes drug to include Japan. Report

> Shares of Human Genome Sciences soared 30 percent earlier today after researchers reported that Albuferon hit its primary goal in a late-stage trial. Data demonstrated that Albuferon is as effective as Pegasys, the current standard therapy for hepatitis C. Report

> Stefan Kappe, a scientist at the Seattle Biomedical Research Institute, has identified an experimental malaria vaccine that will begin clinical trials next year at Walter Reed Army Institute of Research. Report

> Experimental drugs aimed at correcting three rare conditions linked with autism are beginning early-stage human trials. Scientists involved say that the data suggests the treatments could reverse the damage wrought by the ailments. Report

> Eli Lilly probably won't get a decision from FDA this year on whether its diabetes drug Byetta can be used as monotherapy as well as an add-on treatment; yesterday we reported that the delay affected extended-release Byetta, but that's a separate issue. Release

And Finally... It could have been the world's first prescription pistol--but FDA determined that Palm Pistol isn't a medical device. Report

Suggested Articles

Compared with the FDA "boxed warning," the EMA version puts a smaller restriction on the higher dose but broadens the cautionary language.

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.