Pharma investors who may have hoped for a hepatitis C virus (HCV) contender to surface from Merck & Co. Inc. likely were disappointed as Gilead Science Inc.'s backers cheered the less-than-spectacular though eagerly awaited results from the trial known as C-SWIFT. Read More
Battered and bruised Dendreon Corp. has filed for Chapter 11 bankruptcy protection, assuring patients the Seattle company's prostate cancer treatment, Provenge (sipuleucel-T), will remain available as it advances plans to restructure its debt, either through a stand-alone recapitalization or company sale. Read More
SHANGHAI – China's hospitals are now required to centralize financial management of clinical trials, set up an enhanced supervision system and strengthen their use of project management tools. Read More
HONG KONG – China's proposed biosimilar guidelines could open the door for more competition among domestic and foreign producers even though some issues remain unclear, such as the development of more complex next-generation products and how regulators will deal with naming issues. Read More
Sage Therapeutics Inc. said 73 percent of patients with super-refractory status epilepticus (SRSE) who were treated with SAGE-547, its allosteric modulator of synaptic and extra-synaptic GABAA receptors, were successfully weaned from medication keeping them in medically induced comas to prevent persistent seizure. Read More
Arguing against the FDA's effort to retroactively fill a "substantial gap" in its regulatory framework for analyzing complex, naturally derived mixtures for exclusivity purposes, Omthera Pharmaceuticals Inc. petitioned the agency to grant five-year new chemical entity (NCE) exclusivity to its prescription fish oil drug Epanova. Read More
The Centers for Disease Control and Prevention (CDC) is in pursuit of a second patent for the Ebola virus, a move presumably designed to prevent the private sector from restricting research on the virus and thus allow drugs and diagnostics to develop unimpeded by intellectual property considerations. Read More
After keeping its head down following its launch two years ago, Ziarco Group Ltd. came up for air to raise a $33.1 million series B round that will propel its two most advanced compounds through proof-of-concept studies. Read More
Gtx Inc., of Memphis, Tenn., entered a securities purchase agreement to sell $43.4 million of its common stock and warrants to purchase common stock in a private placement. Read More
Orexigen Therapeutics Inc., of San Diego, reported third quarter results with a net income of $11.3 million, or 9 cents per share, compared with last year's net loss of $18.6 million, or 19 cents per share. Read More
Oncosec Medical Inc., of San Diego, and researchers at Old Dominion University and Eastern Virginia Medical School received a $585,000 grant from the Virginia Biosciences Health Research Corp. to study a novel gene therapy approach to treat malignant melanoma. Read More
Conatus Pharmaceuticals Inc., of San Diego, presented a late-breaking poster on rapid and statistically significant reduction of markers of apoptosis and cell death in subjects with mild, moderate and severe hepatic impairment treated with a single dose of its pan-caspase inhibitor, emricasan. Read More
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., released positive results from a recently conducted clinical trial of its bendamustine hydrochloride product, in which the dose was delivered in a 50 mL admixture in 10 minutes vs. a 500 mL admixture in the 60-minute infusion required for Treanda (bendamustine; Cephalon Inc.). Read More
Intas Pharmaceuticals Ltd., of New Delhi, said Singapore investment company Temasek has acquired a 10.2 percent equity stake in the company by way of a secondary purchase of shares from private equity investor Chryscapital. Read More
Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, initiated U.S. sites for its RE-VERSE AD trial, a phase III study testing the abilities of its humanized antibody fragment idarucizumab to act as an antidote to its anticoagulant Pradaxa (dabigatran etexilate mesylate) when patients require emergency intervention or experience an uncontrolled or life-threatening bleeding event. Read More
