Myriad Genetics' BRCA1 and BRCA2 gene patents are ruled invalid by a New York district court.
The court concludes that DNA isolated from the body is not markedly different from DNA as it exists in the body and is thus unpatentable. It also finds that comparisons of DNA sequences are abstract mental processes and therefore unpatentable.
FDA issued a "complete response" letter for Abbott/AstraZeneca’s cholesterol-lowering drug Certriad; release of lackluster ACCORD trial data on efficacy of fenofibrate and statin combinations probably played a role.
Cephalon received a FDA "complete response" for Nuvigil for the treatment of excessive sleepiness linked to jet lag. The agency questioned the "robustness" of some clinical data in the letter, even though Nuvigil demonstrated statistical significance for primary endpoints.
Retiree drug subsidy tax under health reform law likely to boost Medicare Part D enrollment, federal spending – and attention to controlling drug costs.
