Eli Lilly and Co., of Indianapolis, said it accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, and will extend the phase III trial of evacetrapib, a selective inhibitor of cholesteryl ester transfer protein, by approximately six months. Read More
Flex Pharma Inc., of Boston, said findings based on three randomized, blinded, placebo-controlled crossover trials in 37 healthy volunteers showed that leg cramps are caused by excessive firing of alpha-motor neurons in the spinal cord that control muscle contraction. Read More
Cerulean Pharma Inc., of Cambridge, Mass., said preclinical data for CRLX101, a tumor-targeted nanoparticle-drug conjugate designed to concentrate in tumors and slowly release anticancer payload camptothecin inside tumor cells, showed that, in an ovarian cancer model, CRLX101 monotherapy was highly efficacious, and chronic low-dose CRLX101 in combinaton with Avastin (bevacizumab, Roche AG) reduced hypoxia-inducible factor-1 alpha up-regulation and resulted in synergistic efficacy, with minimal toxicity in mice. Read More
Pharmacyclics Inc., of Sunnyvale, Calif., disclosed results for the fourth quarter and for 2014, recording in the first full year of Imbruvica (ibrutinib) sales total revenue of $730 million, driven by U.S. net product revenue of $492 million for 2014, compared to U.S. net product revenue of $14 million for the prior year. Read More
Redhill Biopharma Ltd., of Tel Aviv, said underwriters of its public offering of 1 million American depository shares (ADSs) exercised in full their option to purchase 150,000 additional ADSs at $12.50 apiece as overallotments, extending total proceeds to approximately $14.4 million. Read More
The FDA announced in a conference call this week that it is moving forward with development of a regulatory framework for next-generation gene sequencing systems, acknowledging at the outset that the task requires a substantially more streamlined approach than is currently available for in vitro diagnostics. Read More
Named for a type of duck but definitely lacking any waddle in its step, Merganser Biotech Inc. made a big splash in the rare disease pond by reeling in a $28 million series A round led by the Novartis Venture Fund and joined by Frazier Healthcare, Sutter Hill Ventures and Osage University Partners. Read More
Antioxidants seem to be on a Bill Cosby-like downward spiral from wholesomeness to villainy. The newest accusations can be found in the Feb. 9, 2015, issue of Cancer Cell, where scientists reported that antioxidants drove both the initiation and the progression of tumors, and that blocking antioxidant pathways could destroy tumor cells. Read More
Neurocrine Biosciences Inc., a San Diego company developing drugs for neurological and endocrine disorders, is banking $250 million in a public offering of about 6.9 million shares priced at $36 each to fund a growing roster of trials, rising R&D costs and plans to market its phase III tardive dyskinesia therapy, NBI-98854, ahead of an anticipated 2016 filing of its new drug application (NDA) for the movement disorder. Read More
LONDON – The industry has escalated its campaign against European governments sanctioning off-label use of drugs in order to cut their pharmaceuticals bills, filing a legal complaint against a law passed in Italy in May 2014 that opened the way to use of products outside their approved indications. Read More
Bellerophon Therapeutics Inc., of Hampton, N.J., appointed Deborah A. Quinn vice president and medical lead for the inopulse programs, and Martin Dekker vice president of device engineering. Read More
