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.
Regado Biosciences just got called for its third strike by the safety board. The biotech, which raised tens of millions of dollars to fund a go-it-alone clinical program for an experimental anticoagulant, says the board called on Regado to shutter its Phase III study after determining that the serious allergic reactions investigators had recorded in the study made it impossible to go on.
Following fast on the heels of a rival development team at Novartis, Eli Lilly has posted a superior therapeutic profile for its experimental late-stage psoriasis drug ixekizumab compared to Pfizer's Enbrel in a head-to-head study. And Lilly says the results are good enough to back a regulatory filing in the first half of 2015 for its IL-17A therapy as it races to gain some new approvals following a punishing onslaught of generic competition to its top drug franchises.
About 9 months after NovaBay Pharmaceuticals reported that its lead anti-infective therapy auriclosene had failed a Phase IIb study for impetigo, the little biotech was forced to come back and concede another setback as an opthalmic solution of the same treatment flunked a IIb for viral conjunctivitis, or pink eye, failing the primary and all secondary endpoints.
Back in 2012, researchers flagged some positive results for patient subgroups in a flunked trial of Merck KGaA's cancer vaccine. But now, the vaccine has hit another snag, failing to hit its primary endpoint--as well as three secondary endpoints--in a Japanese trial, partner Oncothyreon said Monday in an SEC filing.