A new wave of biotech investors is learning just how risky the drug development game can be. Onconova, which went public last year with the big class of 2013, says that its late-stage study of rigosertib for high-risk myelodysplastic syndromes failed to achieve a statistically significant improvement in overall survival compared to standard supportive care.
Bayer has posted a fresh set of positive data on its hemophilia therapy BAY94-9027. But with a timeline that doesn't anticipate a regulatory filing until next year, at least one prominent analyst says that Biogen Idec still commands a lead in their race to the market.
Looking to wrap up its package of data to present to the FDA on its anal pain drug VEN 307, Ventrus Biosciences instead wound up with a failed Phase III study as a high placebo response wiped out the efficacy advantage that they were expecting.
In an interview with Bloomberg, COO John Milligan says the big biotech outfit--which is expected to generate megablockbuster revenue from the newly approved Sovaldi for hep C--is pondering a head-to-head study to determine whether Letairis is better or worse than Actelion's recently approved lung drug Opsumit.
Last year, CRO BioClinica saw its most rapid growth in Europe, the company said, and now, as it prepares to join forces with CCBR-Synarc in its second merger in as many years, the clinical trial outfit plans to deepen its investment in the continent.
Furiex Pharmaceuticals says it collected positive data from a pair of late-stage studies on its lead drug for irritable bowel syndrome. The developer expects the data to spur interest in a buyout based on what it sees as "blockbuster" potential for its therapy.
Canadian CRO Algorithme Pharma has expanded its Montreal clinic to include a dedicated unit for complex trials, adding 41 beds to its flagship facility.
A few days ago, as Pfizer executives reviewed the pharma giant's numbers for 2013 and plans for 2014, analysts detected a growing willingness to see if they could hunt up an accelerated approval for palbociclib if the Phase II study for breast cancer rang up promising results.
Aveo Oncology and Astellas Pharma are shutting down a Phase II study of tivozanib in breast cancer after failing to enroll enough patients, the partners announced.
Johnson & Johnson is the latest Big Pharma company that has vowed to open its clinical trial data vaults to the public, and to help it do that, it's enlisting the help of Yale University.