A long, rough patch in Fragile X syndrome drug R&D just got longer and rougher. Roche has notified patient groups that both of its mid-stage studies for RG7090--an mGluR5 therapy--failed to hit the primary and secondary goals, prompting the pharma giant to shut down the program.
Provista Diagnostics is celebrating some early clinical data that support its approach of using autoantibodies and serum protein biomarkers together to help differentiate between invasive breast cancer and benign breast conditions.
Investigators for GlaxoSmithKline detailed their promising Phase III data for the IL-5 biologic mepolizumab in asthma today, noting that the injectable halved the rate of exacerbations among a group of patients with uncontrolled cases of the respiratory disease. But while the pharma giant was making its case for a lower dosage of the drug for a particular profile of asthma patient, an expert in the field raised the prospect that GSK's biggest competitor in the real world may simply be cheaper therapies applied with proper compliance to the medical guidelines already in place.
European CRO Venn Life Sciences has agreed to pitch in on a major international study of a new stent that harmlessly dissolves in the body.
TransCelerate BioPharma, a nonprofit founded by some of the world's biggest drugmakers, is looking to standardize how the industry protects patient privacy when sharing data.
AstraZeneca was forced to concede a clinical defeat on Monday, noting that one of its top respiratory drugs in the clinic failed a study for severe chronic obstructive pulmonary disease. But while investigators also flagged a higher rate of adverse events for benralizumab than the placebo arm, the pharma giant shows no signs of backing away from a treatment it's billed as a potential $2 billion per year product.
Countless clinical trials are done in by unexpectedly well-performing placebo arms, a phenomenon particularly common in psychiatric studies. PPD believes a new, proprietary trial design can substantially level the playing field, and the CRO has paid an undisclosed sum to get its hands on the technology.
Edison Pharmaceuticals' in-development rare disease treatment missed its primary endpoint in a mid-stage trial, denting the company's plans for an expansive take on CNS R&D.
Another Big Pharma player is joining the hustle toward an Ebola vaccine as the death toll surpasses 1,900 victims, eclipsing the total number of people who died from the disease in all previous outbreaks combined.
Eli Lilly took another big step toward filing its long-acting insulin peglispro for an approval, racking up some more positive HbA1c Phase III data in a head-to-head showdown with Sanofi's bestselling Lantus.