Less than three months after the FDA rejected insomnia candidate suvorexant, the agency issued a complete response letter (CRL) for another Merck & Co. Inc. drug, giving analysts and investors additional ammunition in the call for a “major restructuring” in the company’s R&D division. Read More
Given the devil in the details of the SEC’s amendments implementing Title II of the Jumpstart Our Business Startups (JOBS) Act, some angels fear that what Congress intended as a way to help start-ups raise money before going public could make participating in Rule 506 private offerings even riskier. Read More
A Phase III trial of Achaogen Inc.’s plazomicin for serious multidrug-resistant gram-negative bacterial infections will be carried out through a special protocol assessment (SPA) under a new agreement with the FDA. The trial will assess safety and efficacy of the drug compared with colistin in patients with bloodstream infections and nosocomial pneumonia caused by carbapenem-resistant Enterobacteriaceae (CRE). Read More
LONDON – Ablynx NV signed an $840 million licensing deal with Abbvie Inc. for its ALX-0061 nanobody targeted against the cytokine interleukin-6 receptor (IL-6R), in the treatment of rheumatoid arthritis and systemic lupus erythematosus. Read More
SHANGHAI – Beijing newcomer Canbridge Life Sciences Ltd. has partnered with emerging nanotech specialist Azaya Therapeutics Inc., of San Antonio, to develop non-small-cell lung cancer (NSCLC) treatment ATI-1123 in China and North Asia. Read More
Roughly a year ago, Stanford University professor Brian Kobilka was in the spotlight, participating in a press conference after winning the 2012 Nobel Prize in Chemistry, along with Duke University’s Robert Lefkowitz, for studies of G-protein-coupled receptors (GPCR) – the target of some 50 percent of currently marketed drugs, according to background information on the prize cited by the Royal Swedish Academy. Read More
• Galena Biopharma Inc., of Portland, Ore., closed the exercise in full of the underwriters’ option to purchase an additional 2.625 million shares of common stock of Galena. Read More
• Immune Pharmaceuticals Inc., of Tarrytown, N.Y., said the symbol for its common stock trading on the OTCQX trading platform will change to IMNP. The company’s common stock had been required to trade under the symbol EPCTD since Aug. 21 as a result of a previously implemented 1-for-40 reverse stock split. Read More
• BG Medicine Inc., of Waltham, Mass., said results of a research study conducted at the Massachusetts General Hospital provided additional evidence that elevated levels of galectin-3 predict adverse outcomes in chronic heart failure and suggested the prognostic value of the noninvasive biomarker may be enhanced when serial measurements are made over time. Read More
• Teva Pharmaceutical Industries Ltd., of Petach Tikva, Israel, said that the U.S. District Court for the District of New Jersey gave it a favorable ruling in a patent infringement lawsuit against Mylan related to Azilect (rasagiline tablets) for Parkinson’s disease. Read More
