Clinical Trials

Latest Headlines

Latest Headlines

With a Duchenne MD patient struggling for life, little Akashi suspends study

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."

Anti-PD-1? Well, no, says Medivation as a partial hold forces a halt to 'pivotal' cancer study

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 pulls forward target date for solid tumor data, reiterates intent to file IPO

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 swings for $50M haul as oft-delayed IPO nears D-Day

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.

French CRO Biotrial tries to move forward after disastrous clinical study

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.

BioClinica buys into cost management with its latest deal

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.

UPDATED: Alkermes slammed as top depression drug fails two PhIIIs

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.

J&J; halts a depression program in the shadow of a fatal French trial

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 to submit Ebola vaccine for regulatory approval in 2017

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.

Crippled by 2 deaths, Zafgen says obesity drug cut weight in PhIII

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.