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.
Biotrial, the CRO that ran a Phase I study that proved deadly, said it's working with authorities to piece together what went wrong while trying to move its business forward.
Acquisitive CRO BioClinica bought a firm that specializes in handling the financial side of clinical trials, picking up technology that automates how sponsors and contractors pay for studies.
Alkermes reported this morning that its closely watched depression drug ALKS-5461 failed to hit the primary endpoints in the first two of three Phase III studies, slamming the company and the troubled field of depression drug research with a serious setback.
In the wake of a disastrous French clinical trial that left one volunteer dead, Johnson & Johnson has voluntarily suspended development of a similar drug until more information comes to light.
Merck's candidate is the furthest along in the quest for an Ebola vaccine, having posted interim Phase III data showing 100% efficacy last July. Now, the Big Pharma has won $5 million from Gavi, the global vaccine alliance, to help see its candidate through late-stage trials, licensure and prequalification by the WHO, and plans to submit the vaccine for regulatory approval by the end of 2017.
With its clinical development program for a new obesity drug in limbo following the unexplained deaths of two patients, Zafgen reported today that the troubled Phase III study hit its co-primary efficacy endpoints in treating a rare eating disorder.