Two weeks ago, the NIH and FDA had their say to the Senate Health, Education, Labor and Pensions (HELP) Committee on how to enable those agencies to most effectively speed the development of new drugs and devices. Read More
La Jolla Pharmaceutical Co. (LJP) moved ever so cautiously into its first phase III trial in more than a decade, advancing lead compound LJPC-501 (angiotensin II) into ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 to treat catecholamine-resistant hypotension (CRH). Read More
Semma Therapeutics Inc., a company developing a stem cell-based therapy for type 1 diabetes that could reduce or eliminate some diabetics' reliance on daily insulin injections, has closed a $44 million series A led by MPM Capital. Read More
Glitches in the law that created the 340B drug discount program for safety net health care providers are creating oversight problems and raising questions about the intent of the program. Read More
SINGAPORE – Despite a number of advantages as a site for early stage clinical trials, Asia not only lags other regions in the world but the proportion of studies it hosts is actually dropping. Read More
HONG KONG – Marking an important shift in the way the biotech industry operates in Asia, companies are increasingly willing and eager to share information with their peers, governments and industry associations to develop new and more effective immunotherapies. Read More
Blueprint Medicines Corp., a Cambridge, Mass.-based company developing therapies for patients with genomically defined diseases driven by abnormal kinase activation, has filed for an initial public offering. Read More
Conatus Pharmaceuticals Inc., of San Diego, and its research collaborator, Bioreliance, St. Louis-based Sigma-Aldrich Corp.'s biologics and early development services business, presented data at the Society of Toxicology meeting in San Diego describing previously announced results of a six-month evaluation of emricasan, Conatus' orally active, irreversible pan-caspase protease inhibitor, in the Tg.rasH2 humanized mouse model, which is highly prone to developing cancer. Read More
Medigene AG, of Martinsried, Germany, said its phase I/II trial testing its dendritic cell (DC) vaccine in acute myeloid leukemia (AML) has started. Read More
Teikoku Seiyaku Co. Ltd., of Tokyo, said its U.S. subsidiary, Teikoku Pharma USA, submitted a 505(b)(2) new drug application for docetaxel injection concentrate, non-alcohol formula and has received an acknowledgement of receipt from the FDA. Read More
Merck & Co. Inc., of Whitehouse Station, N.J., said the pivotal phase III study (KEYNOTE-006) testing PD-1 inhibitor Keytruda (pembrolizumab) against Yervoy (ipilimumab, Bristol-Myers Squibb Co.) in the first-line treatment of patients with advanced melanoma met its two primary endpoints of progression-free survival and overall survival. Read More
