The president's choice for the next head of the FDA is Robert Califf, a cardiologist who has overseen several clinical trial initiatives at Duke University and founded both the Duke University Clinical Research Institute and the Duke Translational Medicine Institute. Read More
In a potentially lucrative new deal for Xencor Inc., the company is licensing its Xmab antibody engineering technology to Amgen Inc. for inclusion in a series of preclinical bispecific antibodies targeting areas of cancer immunotherapy and inflammation. Read More
Celgene Corp. is tapping San Francisco-based Nurix Inc. to discover and develop several new therapies targeting the ubiquitin proteasome system (UPS) for the treatment of cancer, inflammation and immune disorders. Read More
Shares of Intra-Cellular Therapies Inc. (NASDAQ:ITCI) hit a 52-week high after unveiling top-line data from the first phase III study of ITI-007, showing the drug met the primary endpoint of antipsychotic efficacy in acutely exacerbated schizophrenia, without demonstrating the side effects that usually lead to patients discontinuing treatment. Read More
BOSTON – Cash-strapped new firms looking to jump the chasm between inception and an empowering series A round got some tips during Biopharm America's "start-up day," as a roundtable of experts took up alternate financing routes and codes of conduct in starting talks ahead of sealing deals. Read More
HONG KONG — A new peptide-based drug delivery system has been shown for the first time to enable therapeutic proteins and possibly other drugs to cross the blood-brain barrier (BBB), which may help in treating multiple sclerosis (MS) and other central nervous system (CNS) disorders such as Alzheimer's disease and Parkinson's disease, Korean researchers reported. Read More
A new drug-device combination therapy could make a tremendous impact for mental health patients who are often challenged with nonadherence to treatment regimens. Read More
Aquinox Pharmaceuticals Inc., of Vancouver, British Columbia, said it closed its underwritten public offering of 6.325 million shares of its common stock, including 825,000 shares sold by underwriters who exercised in full their option to purchase additional shares at $15.50 per share. Read More
Espero Pharmaceuticals Inc., of Jacksonville, Fla., said it inked an exclusive licensing and distribution agreement with G. Pohl-Boskamp GmbH & Co., of Hohenlockstedt, Germany, for Pohl-Boskamp's nitroglycerin sublingual powder formulation to treat an attack or for prophylaxis of angina pectoris for the U.S. market. Read More
Lion Biotechnologies Inc., of New York, presented data from a phase II study at the Inaugural International Cancer Immunotherapy Conference in New York showing that its tumor-infiltrating lymphocyte (TIL) therapy in heavily pre-treated patients with metastatic melanoma was associated with high, durable objective response rates (ORRs), including in patients who were refractory to checkpoint inhibitors. Read More
