ProQR Therapeutics has pushed back the date on which it expects to deliver data from its cystic fibrosis clinical trials. The delay means it may be late 2016 before ProQR presents data on its challenger to Vertex Pharmaceuticals' grip on the cystic fibrosis market.
Texas upstart XBiotech made a string of embarrassing mistakes in a Phase III trial on its lead cancer therapy, misdosing some patients and failing to adequately test others on the way to a staggering mishap.
GlaxoSmithKline's experimental Ebola jab, which was taken to Phase I in the U.S. and Mali last October, was well-tolerated and elicited strong immune responses in adults.
France's Genfit says it is preparing to launch its Phase III study of the NASH drug elafibranor. The biotech plans to recruit 1,800 patients for the study at 200 centers worldwide.
Clovis Oncology says that the FDA demanded fresh efficacy data for the lung cancer drug rociletinib (CO-1686) in order to complete its review. And while the biotech plans to hand that over today, it adds that the fresh data include a worse response rate than expected and could force a delay in the accelerated March 30, 2016, deadline that the FDA had set for a marketing decision.
Four years ago, when Derma Sciences reported out positive Phase II data for its diabetic foot wound healing remedy DSC127 (aclerastide), CEO Edward Quilty called the results "transformational" and excitedly predicted big things ahead for the Phase III study. This morning, though, the company was forced to concede that the Phase III was a flop and hinted at some restructuring ahead.
Forum Pharmaceuticals has gotten out from under an FDA clinical hold on a Phase III schizophrenia study for its lead drug, but the company's efforts to develop the treatment for Alzheimer's disease remain halted.
Barely a month after reporting promising Phase II results for its respiratory syncytial virus (RSV) jab and netting an $89 million Gates Foundation grant, Gaithersburg, MD-based Novavax is going full steam ahead, initiating a Phase III trial for its RSV candidate.
AstraZeneca says it has a prime late-stage drug contender in the clinic that has the potential to compete for the lupus market. But it is lining up against GlaxoSmithKline, which has been touting promising Phase III data this week for a new subcutaneous formulation of Benlysta, a drug that has frequently disappointed analysts who have been tracking its sales over the years.
One of Agios Pharmaceuticals' blood cancer treatments demonstrated promise in a Phase I study against solid tumors, but the results fell short of some investors' expectations, sending the company's share value down about 10%.