One year after securing startup financing, Clovis has acquired rights to a second program, this time Avila's EGFR mutant-selective inhibitor program.
The U.S. Supreme Court has asked the Solicitor General for the government's views on whether the Hatch-Waxman Act pre-empts state tort claims that the labeling on a generic drug did not adequately warn of the product's risks. Pliva, Teva, UDL Laboratories and Actavis Elizabeth have petitioned the court to review an appeals court ruling that found manufacturers of generic Reglan (metoclopramide) were responsible for taking steps to warn of new safety hazards with the drug.
Endocrinologic and Metabolic Drugs Advisory Committee meets Thursday to discuss Theratechnologies' EGRIFTA (tesamorelin acetate), a growth hormone releasing hormone analogue intended to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy; FDA is skeptical this will confer a cardiac benefit.
Neurocrine Biosciences appears to be in the final stages of securing a partner to advance into Phase III elagolix, its drug for non-menstrual pain in women with endometriosis; execs announced positive Phase II data for the drug on May 24.