Durect Corp., better known as a drug delivery firm, disclosed a successful phase I trial with DUR-928, described as an endogenous small-molecule new chemical entity that could work in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), as well as acute kidney injury. Read More
Recognizing the NIH's role in driving biomedical advances and the economy, a House appropriations subcommittee seemed supportive Tuesday of a $1 billion bump in NIH funding – provided Congress does away with the threat of sequestration. Read More
SAN FRANCISCO – In the wake of last year's hot IPO market, this year's climate is likely to be significantly cooler, giving way to between 25 and 30 U.S. biopharma IPOs, projected venture captialist Brent Ahrens and banker Jennifer Jarrett during a "crystal ball" panel at the CalBio 2015 conference, a gathering of California industry mavens organized by BayBio and Biocom, the state's biggest life sciences trade associations. Read More
SHANGHAI – Making a strong move to enter China's cardiovascular (CDV) market, Shanghai-based Eddingpharm Co. Ltd. inked a deal with Amarin Corp. plc, of Dublin, to bring Vascepa to Greater China. Read More
DUBLIN – A newly published analysis from Germany's main health technology assessment agency, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG), concluded that the benefit assessment process Germany introduced for new drugs in 2011 has narrowed the information gap on new medicines and provided a fuller understanding of their benefits and risks than that available from other regulatory and academic sources. Read More
HONG KONG – Known already as the first China-manufactured biologic used in U.S. trials, HIV candidate ibalizumab (TMB-355) won FDA breakthrough therapy designation, which could substantially accelerate the product's launch. Read More
Blueprint Medicines Corp. will bank $15 million as an up-front payment from Cheshire, Conn.-based Alexion Pharmaceuticals Inc. as a kick-off to their strategic collaboration that will center on an undisclosed activated kinase target, which is the cause of a rare genetic disease. Read More
Sens. Chris Coons (D-Del.), Dick Durbin (D-Ill) and Mazie Hirono (D-Hawaii) introduced the STRONG Patents Act Tuesday to protect individual inventors and research-intensive companies from frivolous patent lawsuits and to level the playing field between small inventors and large companies. Read More
Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported total net product revenues for the fourth quarter of $13 million, compared to $238 million for the fourth quarter of 2013. Non-GAAP net loss for the quarter was $167 million, or $2.61 per share, far greater than the expected 25-cent-per-share loss predicted by analysts. Read More
Curis Inc., of Lexington, Mass., said it closed its public offering, selling 25.1 million shares at $2.75 apiece, including the exercise in full by underwriters to purchase an additional 3.3 million shares. Read More
Denovo Biopharma LLC, of San Diego, said it exclusively licensed pomaglumetad methionil, a late-stage mGlu2/3 receptor agonist, from Eli Lilly and Co., of Indianapolis, gaining all rights to develop, manufacture and commercialize the drug globally, including transfer of all intellectual property and other rights, data and information. Read More
Melior Pharmaceuticals Inc., of Exton, Pa., randomized the first patient into treatment arms of a phase II study aimed at evaluating the efficacy of MLR-1023 in type 2 diabetes. Read More
Pfizer Inc., of New York, said the European Commission approved an expanded indication for the use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 and older. Read More
