The Federal Circuit ruled in the Myriad gene patent case that “isolated” DNA molecules are patent eligible and that the method of screening potential cancer therapeutics via changes in cell growth rates of transformed cells is also patentable. However, the court found that Myriad’s claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible. The American Civil Liberties Union brought the case on behalf of medical organizations, researches and breast cancer and women’s health groups to challenge patents covering Myriad’s test to detect gene mutations linked to breast and ovarian cancer.
The draft of stage 3 of the meaningful use requirements for electronic health records includes adverse event reporting, something on FDA’s wish list for EHR functionality.
Idenix announced FDA has placed a partial clinical hold on its hepatitis C candidate IDX184 after Bristol-Myers Squibb was forced to halt a study of its similar drug following a serious cardiovascular event. The news sparked new worries concerning a class effect for nucleoside polymerase inhibitors, though Gilead stood by its candidate’s clean CV profile.
New austerity measures are making Italy a less attractive place for big pharma to invest but are buoying the generics sector.