The FDA put some lift under the wings of Raptor Pharmaceutical Corp., approving the orphan drug Procysbi (RP103, cysteamine bitartrate delayed-release) on its PDUFA date in the initial indication of nephropathic cystinosis (NC). Read More
Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC). Read More
One of the most basic ways to classify neurons is by the transmitter they use to communicate. And that transmitter was long thought to be "immutable," Davide Dulcis told BioWorld Today. One dogma of neuroscience has long been that "no matter what you do to a neuron, once it's GABAergic, dopaminergic or what have you, it's not going to change for the rest of its life." Read More
SAN FRANCISO – One-third of all biotechnology deals in 2012 were for oncology assets, according to Deloitte Recap LLC, a higher percentage than any other therapeutic area. Read More
The possibility of an initial public offering (IPO) – noted in December, when Regado Biosciences Inc. collected $51 million in a Series E financing intended to help fund Phase III trials – moved closer to reality, as the firm filed a registration statement to trade on Wall Street. Read More
Oxford BioTherapeutics (OBT) Ltd. entered a target validation deal with Boehringer Ingelheim GmbH that will offer near-term revenues, with the added prospect of long-term development milestones and product royalties. Read More
• CytoDyn Inc., of Lake Oswego, Ore., said it and Drexel University entered a deal with contract development and manufacturing firm Ajinomoto Althea Inc. to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies. Read More
• Transition Therapeutics Inc., of Toronto, reported results of a five-week proof-of-concept study testing TT-401 in Type II diabetic and obese nondiabetic subjects, showing that once-weekly treatment demonstrated significant improvements in glycemic control and reductions in body weight. Read More
• CSL Behring, of Marburg, Germany, said the FDA approved Kcentra (prothrombin complex concentrate, human) for the urgent reversal of vitamin K agonist anticoagulation in adults with acute major bleeding. Read More
