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.
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.
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.
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.
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.
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.
HONG KONG – Looking to position itself as the biggest player in the rapidly growing traditional Chinese medicine (TCM) market in China, the TCM arm of Chinese state-owned Sinopharm Group is planning on a $1.3 billion acquisition of an industry rival and the sale of a biotech subsidiary to channel resources to the development of its TCM business, a move that will help consolidate the market.
Basilea Pharmaceutica Ltd.'s licensing partner Astellas Pharma Inc. won the favor of the FDA's Anti-Infective Drugs Advisory Committee for the antifungal isavuconazole, achieving a slam-dunk vote of 8-0 to recommend approval in the invasive aspergillosis indication, though the panel's balloting proved less certain about the rarer invasive mucormycosis: 8-2 in favor, with one abstention.
3SBio Inc., of Shenyang, China, has acquired the entire share capital of contract manufacturing company Sirton Pharmaceuticals SpA, of Villa Guardia, Italy, from First Shanghai Ltd. Financial terms were not disclosed.
HONG KONG – The global orphan drugs market has been growing steadily, becoming big enough to garner the attention of big pharmaceutical companies, and rare disease patients in Asia Pacific will benefit from that trend.
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