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.
Israeli biotech Kamada confirmed that its lead candidate failed to meet both its primary and secondary endpoints in a late-stage trial--but that won't interrupt the company's plans to file for European approval.
Results from Sanofi's dengue vaccine trial are in, and once again, the data confirm its overall efficacy. But notably, this trial also saw an improvement in protection against dengue serotype 2, a viral strain that's tripped up the vaccine in previous studies.
Late on Monday evening Exelixis put out the word that its crucial late-stage study of cabozantinib flunked a comparison study with prednisone for castration-resistant prostate cancer, triggering a restructuring that will eliminate 70% of the jobs at the biotech.
Novartis told the world back in March that its experimental heart drug LCZ696 had delivered the goods early in a pivotal study, allowing for a quick wrap of the Phase III trial. And today the pharma giant painted in the numbers, completing the late-stage picture for a closely watched therapy that has the potential to rival the most successful drug franchises now on the market.
In one of the most improbable rivalries in the drug development world, tiny Dutch biotech Dezima today laid claim to a successful Phase IIb study of its CETP cholesterol drug TA-8995, putting it on track to a 2015 launch for a Phase III showdown with two giants in the field, Eli Lilly and Merck.
Repros Therapeutics got a boost from its announcement that its late-stage testosterone treatment beat out the topical Androgel in helping patients with low testosterone, or hypogonadism.