With another set of positive, top-line phase III results for its pain drug BEMA (bioerodible mucoadhesive) buprenorphine, this time for back pain in opioid-experienced patients, Biodelivery Sciences International Inc.'s (BDSI) partner Endo Pharmaceuticals Inc. plans a sit-down with the FDA later this month to talk about a new drug application (NDA).
Regado Biosciences Inc.'s double-punch anticoagulant took one on the chin from Wall Street, as investors learned about an unplanned review by the data safety monitoring board (DSMB) of the phase III trial testing the drug previously known as REG1 in patients undergoing percutaneous coronary intervention (PCI).
With fast track FDA status for its lead compound against fibrosis in Duchenne muscular dystrophy (DMD) and new financial support from the main disease association through a philanthropy program based on promising preliminary phase Ib/IIa data with oral HT-100 (delayed-release halofuginone), Akashi Therapeutics Inc. takes its place in the race for a new DMD therapy.
The phase II win against newly diagnosed glioblastoma multiforme (GBM) with the heat-shock protein (HSP) vaccine Prophage helped shares of Agenus Inc. to a satisfying rise, and brought hope for patients in the especially virulent form of brain cancer, which usually kills within one year.
A free agent after last July's $704 million buyout of Trius Therapeutics Inc., former CEO Jeffrey Stein was "approached with numerous opportunities" before choosing the earliest-stage prospect and "by far the most exciting one" in antifungals start-up Cidara Therapeutics Inc., he said.
SAN DIEGO – The U.S. tops most lists in biotech, but studying data from other international players can provide lessons for the front-runner and everyone else. Such intent is motivating Scientific American Worldview, in its sixth year of rankings that were detailed during a session on the final day of the BIO International Convention.
SAN DIEGO – With one lawsuit by Abbvie Inc. settled out of court and another by Intermune Inc. pending, the skirmish over what's been hailed as a new era of clinical trial transparency in Europe seems likely to heat up more, as a centrally located database will make available results to just about anyone who asks, said Alexander Ehlers, an attorney with Ehlers Ehlers & Partner in Munich.
SAN DIEGO – Anne Wojcicki, CEO and co-founder of the direct-to-consumer genetic profiling company 23andme Inc., made no attempt to avoid the delicate topic of FDA scrutiny, opting instead to embrace the "exciting adventure" that she said her firm is undergoing with U.S. regulators.
SAN DIEGO – Overseen as usual by Douglas MacDougall, president of MacDougall Biomedical Communications, one of the traditionally livelier sessions at the BIO International Convention again fulfilled its promising title, "Son of a Pitch: Do You Have the Talent to Engage Investors?"
SAN DIEGO – In almost hushed tones to reporters gathered in a corner room of the San Diego Convention Center at BIO 2014, Bionomics Ltd. CEO Deborah Rathjen unveiled late Monday the firm's second deal in less than a year with Merck & Co. Inc., this time a potential $526 million arrangement focused on a preclinical therapy targeting Alzheimer's disease (AD).
