TOKYO - Japan's drug approval process has come a long way, marking a shift in the mindset at Japan's Pharmaceuticals and Medical Device Agency (PMDA). Read More

SHANGHAI – Jiangsu Nhwa Pharmaceutical Co. Ltd.'s DP-VPA, a modified valproic acid (VPA) treatment for epilepsy, has received fast track status from the CFDA. Read More

HONG KONG – Despite all the talk of the bright future of China's biotech industry, the sector in this huge country remains in its infancy. Challenges in areas like funding and regulatory procedures have to be taken into account before stepping into the market, said investors at the Asia Biotech Invest conference. Read More

HONG KONG – A comprehensive catalogue of proteins manufactured in specific parts of Purkinje neurons that was obtained using sophisticated new techniques may improve our understanding of diseases associated with these cells, such as ataxias and autism, possibly leading to the development of badly needed treatments for such disorders, report researchers from the Riken Institute in Japan. Read More

HONG KONG – Over the next decade, competition for market share between biosimilar products and their originator drugs is likely to grow fierce, but price differentiation may not be enough to ensure sales. Read More

HONG KONG – By 2017, the global pharmaceutical market will be worth $1.2 trillion and $250 billion will come from Asia. Those large sums of money should create multiple opportunities for investors that understand the nuances of the region, said industry insiders gathered here. Read More

SHANGHAI – Jiangsu Hengrui Medicine Co. Ltd. released positive phase III data for apatinib at American Society of Clinical Oncology (ASCO) meeting last week and is now waiting for the good word from the CFDA for marketing approval in China. Apatinib, a molecular targeted therapy for the treatment of advanced gastric cancer has been shown to be associated with improved survival in patients with prior failure to second line chemotherapy. Read More

Glenmark Pharmaceuticals Ltd., of Mumbai, India, said its Switzerland-based subsidiary opened a new cGMP-compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland, to supplement the company's existing in-house discovery and development capabilities and to supply material for clinical development. Read More

Spinifex Pharmaceuticals Pty, of Melbourne, Australia, named Ronald Marcus chief medical officer. He will be responsible for driving the development of Spinifex's lead candidate EMA401 and the preclinical pipeline. Read More