Eli Lilly says its closely-watched GLP-1 diabetes drug dulaglutide works as well as the market leading therapy Victoza, but isn't superior to the rival drug. That's going to be good enough for Lilly to claim a big win, though, as analysts were ready to hand it a victory on non-inferiority for a drug now in the hands of regulators.
More than three years after the FDA sent InterMune back to the clinic for another Phase III study of its lung drug pirfenidone--Esbriet--for idiopathic pulmonary fibrosis, the biotech says it scored a win on the primary as well as two secondary endpoints for the lung-scarring treatment. And now InterMune says it's ready to go back to the FDA and lay out the data, hoping for an approval that will greatly expand the market for a drug now sold in Europe.
The New York-based drugmaker is keeping the data under wraps until next month but has revealed the headline results. Primary and secondary objectives were all met.
Investigators at Memorial Sloan Kettering Cancer Center have been pioneering the use of genetically modified T cells to fight cancer. And to underscore the potential of this technology, which they have used to help start up the high-profile Juno Therapeutics, new human data has produced another round of jaw-dropping outcomes from a small but influential study.
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.