HONG KONG – Novartis AG faces a new series of challenges in Japan that stem from a failure to notify authorities of serious side effects associated with two dozen of its drugs. Read More

SHANGHAI – The all-important CFDA looks set to welcome a new commissioner into the fold. Bi Jingquan comes to the top spot with a long resume of government service, the bulk of which was spent at China's economic planning agency, the National Development Reform Commission (NDRC), where he specialized in pricing. Read More

TOKYO – Thanks to a series of policy initiatives, Japan's Pharmaceutical and Medical Device Agency (PMDA) has morphed into a much more nimble regulator, one that processes approvals as fast as the FDA or the EMA. Read More

HONG KONG – A Chinese clinical trial site management organization (SMO) is getting into monoclonal antibodies (mAbs) after acquiring the global development and licensing rights of drug candidates developed by Chinese academic researchers. Read More

NEW DELHI, India – The EMA has recommended suspending the Hyderbad-based contract research organisation (CRO) GVK Biosciences on charges of data manipulation, a decision that once again shines a spotlight on the issue of Western drug firms outsourcing clinical trials to CROs to cut costs. Read More

HONG KONG — Researchers from the Riken Institute in Japan have demonstrated for the first time the profound effect that chronic hepatitis infections can have on the genetic mutations found in liver tumors, potentially paving the way for development of tailored therapies for the different types of liver cancer. Read More

BEIJING – Representatives from 100 Chinese pharma and biotech companies recently participated in a technology transfer conference, with "Chinese characteristics": In between name card speed exchanges, the organizers exhorted attendees to improve the quality of domestic drug innovation. Read More

Hutchison China Meditech Ltd., of Hong Kong, also known as Chi-Med, said subsidiary Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Co. Ltd. entered an exclusive distribution agreement with Astrazeneca (Wuxi) Trading Co. Ltd., a unit of Astrazeneca plc, of London, to distribute and market antipsychotic drug Seroquel (quetiapine) in China. Seroquel, which is approved for the treatment of schizophrenia and bipolar disorder, was launched in China in 2001. Read More