Orexigen Therapeutics Inc. reported higher-than-expected second quarter revenues, helped by royalties on U.S. sales of obesity drug Contrave (naltrexone and bupropion). Shares rose (NASDAQ:OREX) 35 cents, to $4.17 by Thursday's close as the company settled a dispute with its North American partner Takeda Pharmaceutical Co Ltd. and signed a new distribution deal for South Korea.
HONG KONG – Two stem cell labs in China have independently reported the successful transformation of fibroblasts into functional neurons using only chemicals, with one group using human cells from healthy individuals and Alzheimer's patients, while the other used mouse cells, potentially providing other sources of neuronal cells for drug discovery and regenerative medicine.
TOKYO – Six months after winning PMDA approval, Eli Lilly Japan and Nippon Boehringer Ingelheim (NBI) recently disclosed plans to launch the first insulin glargine biosimilar in Japan, a market in which biosimilars are advancing, albeit slowly.
HONG KONG – Recovering from an acquisition bid in June that ultimately sent its shares down by about 20 percent, Chinese drugmaker Luye Pharma Group Ltd. is back on the deal trail, this time with plans to acquire Singapore-based molecular diagnostics firm Vela Diagnostics Pte Ltd.
NEW DELHI – India deferred its talks with the European Union on a broad-based investment trade agreement "for the present, in response to the European Commission's [EC's] July ban on 700 Indian generics." Trade talks between the EU and India were to resume in August, after a gap of two years.
Daiichi Sankyo Co. Ltd., of Tokyo, said the UK's National Institute for Health and Care Excellence recommended its oral, once-daily selective factor Xa inhibitor Lixiana as an option for preventing stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors.
HONG KONG – Boehringer Ingelheim GmbH will add to its lung cancer pipeline with a drug from Hanmi Pharmaceutical Co. Ltd. as part of a deal that could, in the end, be worth as much as $730 million to the South Korean firm.
Otsuka Pharmaceuticals Co. Ltd., of Tokyo, and H. Lundbeck, A/S, of Valby, Denmark, said the FDA expanded the label of Abilify Maintena (aripiprazole) for extended-release injectable suspension to include a new injection site, the deltoid muscle of the arm. Healthcare providers will now have the option for either a gluteal or deltoid injection site for administering Abilify Maintena to patients with schizophrenia.
Bionomics Ltd., of Adelaide, Australia, appointed Tony Colasin chief business officer. Colasin will be based in San Diego and will lead corporate development, including business development and strategic opportunities.
NEW DELHI – In a move that could cost India's generics industry more than $1 billion, the European Commission (EC) has banned 700 Indian generic drugs, based on flaws detected during inspections of clinical trials conducted by Hyderabad-based contract research organization GVK Biosciences Ltd. The flaws pertained mainly to "data manipulations" of electrocardiograms conducted of patients during studies on several generic medicines. (See BioWorld Today, Feb. 4, 2015.)