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.
Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.
Following recent outbreaks in the Pacific and Caribbean, chikungunya virus has made its way to the U.S.--and drug developers have taken note of its continued spread.
AstraZeneca has launched a Phase III test of its targeted IL-13 asthma drug tralokinumab, beefing up its late-stage pipeline for respiratory diseases and squaring off against some major league competition now in the clinic.
AstraZeneca had some upbeat news to report Wednesday morning, noting that a slate of key Phase III combination studies for the gout drug lesinurad crossed the finish line with positive results for three out of four primary endpoints, raising hopes that the once star-crossed pharma giant may be on the verge of a blockbuster approval. And the company says it plans to push ahead with regulatory applications with the late-stage data now in hand.
It's not often that the president of the United States is asked to weigh in on whether an experimental drug should be OK'd for human use ahead of human trials. But when it comes to an outbreak of a lethal virus--even one that's been percolating in equatorial Africa for decades--everything is potential fodder for reporters operating in a 24-hour news cycle.
Cytori Therapeutics hit the brakes on a pair of clinical trials to find out why three patients in the study suffered from "cerebrovascular" events after they were treated with the biotech's experimental stem cell treatment. The San Diego-based biotech's shares plunged more than 30% in after-hours trading after putting out word of the hold in a late release.