ArQule Inc.'s stock plummeted 18.5 percent Wednesday when its partner Kyowa Hakko Kirin Co. Ltd., of Tokyo, suspended patient enrollment in its ongoing Phase III ATTENTION trial of tivantinib in non-small-cell lung cancer.
Resverlogix Corp. reported success in a Phase IIb (SUSTAIN) trial of its small-molecule BET protein inhibitor, RVX-208, designed to increase levels of high-density lipoprotein cholesterol (HDL-C) in patients with atherosclerosis.
The FDA surprised Genzyme Corp., a Sanofi company, with a refuse to file letter for its supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis (MS).
Bristol-Myers Squibb Co. shut down development of its hepatitis C virus (HCV) drug, BMS-986094, following a fatality and nine hospitalizations in a Phase II trial of the drug. The trial was suspended on Aug. 1, and the FDA placed the compound on clinical hold. BMS and the FDA are working together to follow up on the incidents, which involve heart and lung toxicity.
The Medicines and Healthcare Products Regulatory Agency of the UK approved a 300-patient Phase III trial of Northwest Biotherapeutics Inc.'s DCVax-L for glioblastoma multiforme (GBM). Phase III is in full swing in the U.S., at 41 clinical sites, but Northwest seeks to expand the trial to international sites, starting in the UK, stating it will save several years' time by not carrying out separate U.S. and European trials.
Gilead Sciences Inc., of Foster City, Calif., has terminated a Phase II trial of cicletanine for pulmonary arterial hypertension (PAH) due to a failure of the trial to meet its primary endpoint of improvement in exercise capacity.
Regulus Therapeutics Inc., of La Jolla, Calif., inked another two deals related to its microRNA technology. Its agreement with London-based AstraZeneca plc calls for a $28 million up-front cash and equity payment, plus milestones, for development of three microRNA targets.
A new license, development and commercialization agreement between Inspiration Biopharmaceuticals Inc., of Cambridge, Mass., and Paris-based Ispen SA will restructure the existing partnership between the firms and provide additional funding to Inspiration for development of hemophilia drugs IB1001 and OBI-1.
Hot on the heels of two major partnership deals, Regulus Therapeutics Inc. filed a form S-1 with the SEC for a proposed initial public offering (IPO) for $57.5 million to fund its microRNA pipeline.
A report produced by the George Washington University School of Public Health found that prescription drugs could fill a critical treatment gap for obese patients who do not respond to lifestyle interventions and are not candidates for bariatric surgery.
