The crucial late-stage failure--ramucirumab for breast cancer has been considered one of the pharma giant's top Phase III prospects--scuttles one of Eli Lilly's chief hopes for a major new drug approval application. The failure also follows several years of poor trial outcomes for Lilly, which has a reputation for taking expensive and very risky chances when it comes to late-stage development.
Investigators say that the treatment failed to produce a statistically significant improvement in overall survival, forcing the biotech to wash its hands of the program and concentrate on the lead program for IPI-145. The data will be released at a later scientific meeting.
Shares of Oncothyreon soared this morning after its partner Merck KGaA said it would take a second swipe at trying to find some value in Stimuvax, the cancer vaccine (now renamed tecemotide) that has already decisively flunked a Phase III trial.
Two years after AstraZeneca and Bristol-Myers Squibb ran into a buzzsaw of regulatory criticism at the FDA for their SGLT2 diabetes drug dapagliflozin, the partners are back with a fresh set of promising Phase III data they hope can help provide the key needed to unlock the U.S. market.
Cambridge, MA-based Alnylam Pharmaceuticals says it garnered positive interim data from a Phase I study of ALN-TTRsc, an RNAi therapy targeting the transthyretin gene for the treatment of TTR-mediated amyloidosis.
GlaxoSmithKline and Prosensa today conceded defeat in the Phase III study for drisapersen, one of two closely-watched therapies for Duchenne muscular dystrophy which had been vying for the lead in the field. Investigators reported that the therapy failed to significantly improve walking distance in patients.
The money will be used, in part, to pay for a mid-stage study of MOR208, its anti-CD19 antibody for chronic lymphocytic leukemia as well as new studies of MOR202, an anti-CD38 antibody currently in a Phase I/IIa clinical trial in multiple myeloma.
When ChemoCentryx reported last month that its Crohn's disease drug vercirnon (GSK1605786) failed the first of four Phase III trials mounted by GlaxoSmithKline, the biotech said it was awaiting word from the pharma giant on its future development plans.
Shares of NovaBay Pharmaceuticals shot up 11% after the Emeryville, CA-based biotech said that a mid-stage study of a new solution to prevent problems for people with indwelling urinary catheters proved successful, paving the way for a late-stage trial.
Israel's Pluristem Therapeutics says the FDA has given the company a green light to push ahead on a mid-stage study of one of its stem cell therapies after the agency had finished its review of one patient's severe allergic reaction and tweaked the trial protocol.