HONG KONG – Chinese biopharmaceutical companies are upping the ante in the development of biological drugs and biosimilars of existing best sellers, many of them looking to capitalize on the huge domestic market. Read More
HONG KONG – A framework of the guidelines for biosimilar approvals in China should be released in June, and work proceeds apace to have regulations in place by the end of the year, industry insiders told BioWorld Asia. Read More
HONG KONG – Adding the oral molecular targeted therapy Afinitor (everolimus, Novartis AG) to conventional chemotherapy plus anti-HER2 treatment reduced the risk of progression of human epidermal growth factor receptor-2 (HER2) positive advanced breast cancer resistant to Herceptin (trastuzumab, Roche AG) by 22 percent and may provide clues to the mechanisms underlying Herceptin resistance, researchers report. Read More
SHANGHAI – Hutchinson China Meditech Ltd. (Chi-Med) has struck a new deal with its joint venture partner of 13 years, Shanghai Traditional Chinese Medicine Co. Ltd. (STCM), to exclusively sell six prescription drugs in China. Chi-Med's commercial operations help to fund its extensive R&D efforts with seven candidates in the clinic for oncology, immunology and inflammation. Read More
SHANGHAI – Glaxosmithkline plc has confirmed the company is under investigation by the UK Serious Fraud Office (SFO). The case is presumed to be related to the almost year-long corruption investigation into GSK China activities that came to a close last week. UK's largest drugmaker is facing ever more serious legal troubles in its own backyard as the big pharma and its executives are awaiting trial here. Read More
SEOUL, South Korea – With one eye firmly planted on future economic growth, South Korea is taking steps to boost its biotechnology industry by putting resources into a wide range of traditional and emerging subsectors from biosimilars to stem cell treatments. Read More
Macrogenics Inc. enticed another big pharma partner to the table with a candidate from its Dual-Affinity Re-Targeting, or DART platform. Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, took an option to develop and commercialize MGD010, a preclinical asset targeting autoimmune diseases, that uses DART to simultaneously engage the B-cell surface proteins CD32B and CD79B. Read More
SEOUL, South Korea – Promising as the biosimilar market appears today, a consolidation that leaves only a handful of global players may be inevitable and the prospects may not be as rosy as they seem, said drug company executives at Bio Korea 2014. Read More
Zydus Group, of Ahmedabad, India, said it started phase III trials of Lipaglyn (saroglitazar) in patients with lipodystrophy, with the goal of evaluating the drug's safety and efficacy vs. standard of care with placebo. Lipaglyn previously gained approval in India for treating diabetic dyslipidemia and hypertriglyceridemia. Read More
Spinifex Pharmaceuticals Pty, of Melbourne, Australia, appointed Thomas Schnitzer, Roy Freeman, Robert Dworkin and Declan Doogan to its scientific advisory board. Read More