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).
Dimension Therapeutics Inc.'s $20 million up-front gene therapy deal – with the potential for $232 million in milestone payments – comes less than a year after the company was founded and draws to the table Bayer Healthcare Pharmaceuticals Inc., which gains rights to "the strategic must-have for them to maintain an ongoing presence in the hemophilia A space," said Dimension's CEO and co-founder Thomas Beck.
Taking advantage of the immuno-oncology updraft, Kite Pharma Inc. priced an initial public offering (IPO) of 7.5 million shares at $17 each, for gross proceeds of $127.5 million that will help advance its anti-CD19 chimeric antigen receptor (CAR) T-cell therapy.
Sold as a nutritional supplement – before it was ruled a drug by the FDA and went through phase II trials in the hands of Biostratum Inc. – pyridoxamine dihydrochloride entered a pivotal program overseen by Nephrogenex Inc., which is testing the derivative of vitamin B6 (pyridoxine) in diabetic nephropathy.
Insmed Inc.'s eventful ride with Arikayce (inhaled liposomal amikacin) took an upswing with word from the FDA that the compound has achieved breakthrough designation in nontuberculous mycobacterial (NTM) lung disease, despite missing its primary endpoint in a phase II trial in that indication.
Ipierian Inc. spinout True North Therapeutics Inc. will use $22 million from its series A round to push TNT009, its lead candidate, through early stage studies in autoantibody-driven rare diseases mediated by the complement system.
