AbbVie says it has racked up a second set of positive Phase III data for its endometriosis drug elagolix, setting up a regulatory filing for sometime next year.
Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.
Ferring Pharmaceuticals is set to put its prostate cancer drug Firmagon up against AbbVie's Lupron in a Phase IIIb trial. The study is designed to assess the cardiovascular safety profile of the gonadotropin-releasing hormone receptor agonist and antagonist, potentially giving Ferring an edge over a product that generated $826 million (€744 million) for AbbVie last year.
Heptares is gearing up to advance a candidate from its muscarinic M1 receptor agonist program into Phase II in patients with Alzheimer's disease, schizophrenia or Lewy body dementia. While specifics of which drug to aim at which indication are still being decided, Heptares has seen enough in its first clinical data to continue pursuing a target that has shown more promise than most in Alzheimer's.
A little more than a week after Cambridge, MA-based Akashi Therapeutics suspended its study of a new drug for Duchenne muscular dystrophy after a patient was sent to the hospital, the biotech reports that the trial subject has died.
Paris-based Cellnovo Group has partnered with TypeZero Technologies to be part of a previously announced clinical trial of an artificial pancreas that's being backed by a $12.8 million grant from the U.S. National Institutes of Health. Cellnovo's connected insulin patch pump will be used in conjunction with TypeZero's inControl AP software and a Dexcom continuous glucose monitor to form the whole of the artificial pancreas system being tested.
French Health Minister Marisol Touraine has criticized the CRO behind a botched drug trial that has seen one die and 5 others seriously ill for failing to stop the study.
French health regulators have yet to determine exactly went wrong in a drug trial that left one volunteer dead last month, working to establish the cause of a Phase I disaster that has shaken up the drug industry.
Catalent Pharma Solutions is building up its clinical supply capabilities in Asia, expanding a Singapore facility as it works on a sizable expansion in Japan.
Pfizer has quietly shuttered a Phase II Alzheimer's drug study, noting the termination in a pipeline update released today with its annual numbers for 2015. And shares of Axovant tumbled 16% on the news as it faces fresh questions about the implications of the failure on a similar drug it has pushed into a Phase III trial.