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.
Nonprofit-backed Akashi Therapeutics has suspended a trial of its lead drug for Duchenne muscular dystrophy after a patient on the highest dose experienced "life-threatening health issues."
When Medivation bought out the rights to CureTech's pidilizumab, it trumpeted its entry into checkpoint inhibition with a drug that aimed right at PD-1, unleashing a T cell attack on cancer. Except that Medivation recently concluded that the drug doesn't work that way after all--and now the FDA has red-flagged a pivotal study of the drug, halting the trial through a partial clinical hold while Medivation takes another stab at explaining the mechanism of action.
Merus has shaved months off the date on which it expects to release data from a Phase I/II trial of its lead bispecific antibody in HER2-expressing solid tumors. The Dutch immuno-oncology player provided the new timeline in an update to the paperwork it filed ahead of a planned Nasdaq IPO.
Mapi Pharma has set the terms for its latest crack at listing on Nasdaq. The biotech, which set terms on its first IPO attempt back in April 2014, is aiming to round up around $50 million (€46 million) to bankroll development of its once-a-month version of Teva's blockbuster Copaxone.