EMA: Faulty device didn’t distort study findings for Bayer’s Xarelto

Carly Helfand Last December, European regulators said they were no longer sure whether results from a trial of Bayer's new-age clot-buster Xarelto were accurate ...

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

John Carroll 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 ...

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

John Carroll 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 ...

Feds clamp a hold on Forum’s PhIII Alzheimer’s study following GI events

John Carroll The FDA has slammed the brakes on the late-stage Alzheimer's development program for encenicline after investigators reported a "small" number of serious ...

Patient education ‘useless’ when it comes to Eliquis adherence: study

Carly Helfand Good news for partners Bristol-Myers Squibb and Pfizer: In a Phase IV study of their new-age anticoagulant, Eliquis, atrial fibrillation patients posted adherence rates ...

Roche’s $100M Alzheimer’s study could shift the balance in R&D

Damian Garde Despite all the excitement over Biogen's recent Phase I success in Alzheimer's, the question of whether attacking protein buildups in the brain can in fact treat ...

AcelRx hammered (again) after FDA demands a new Zalviso study after all

John Carroll When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required–suggesting it could be back in front of ...

Lilly extends study of highly anticipated cholesterol fighter

Eric Palmer Eli Lilly says it will extend the massive Phase III trial for its highly anticipated drug candidate evacetrapib, a CETP inhibitor that works to lower LDL, or "bad," ...

Little Cortendo gains $11M for late-stage Cushing’s study, hatches U.S. IPO plans

John Carroll Cortendo is coming to America. Founded in Sweden, the little biotech has a new CEO who's building the executive team in the Philadelphia area. And he's dropping ...

Positive PhIII PONV study brings little Acacia to a crossroads

John Carroll Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting. And now it's ...

Mapp’s Ebola treatment comes through in a preclinical study

Damian Garde Tiny Mapp Biopharmaceutical's much-scrutinized Ebola treatment proved 100% effective in animal studies, the company said, stoking hopes that the investigational therapy ...

Study sounds alarm on sleep-aid ingredient zolpidem

Carly Helfand Sleep aids have landed in the safety spotlight recently, with regulatory agencies lowering dosages on some meds to ease side effect worries. But overmedication has its ...
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