Friday, August 9, 2013
Japan-based pharmaceutical company Daiichi Sankyo is expanding its use of Medidata Solutions‘ cloud-based platform to support clinical trials conducted by its division in China, an investment expected to streamline trial activities, improve the efficiency of data capture and increase the productivity of site users and clinical monitors. Daiichi Sankyo will bring Medidata’s applications for electronic data capture, clinical data management and randomization and trial supply management to its expanding clinical work in China.
Raleigh, N.C.-based INC Research, a therapeutically focused global CRO, has established INC Research Japan KK, with the opening of locations in Osaka and the Shinagawa ward in Tokyo. The new operations provide INC Research’s global drug development customers access to an increasingly significant market and further expand its presence in the Asia-Pacific region.
Ascendancy Healthcare, dedicated to the commercialization of therapeutic products to meet unmet medical needs in China and other high-growth Asian markets, has announced a multi-year collaboration with Quintiles, a provider of biopharmaceutical development and commercial outsourcing services.
Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there is an unmet medical need, has announced a personalized medicine collaboration with SciClone Pharmaceuticals in the company’s oral mucositis clinical program with SGX942. Soligenix will receive access to SciClone’s oral mucositis clinical and regulatory data library in exchange for commercialization rights in China, including Hong Kong and Macau.
Pfizer Asia Pacific, GlaxoSmithKline and Siemens are founding members of the A*STAR R&D consortium program Innovative Processing of Specialties and Pharmaceuticals (iPSP). Launched by A*STAR’s Institute of Chemical and Engineering Sciences (ICES), the consortium is a platform for pharmaceutical and specialty chemicals industry companies to address costs, regulatory compliance and responsiveness in production and processes to bring drugs to markets.
Abbott has announced the initiation of the Absorb Japan randomized, controlled clinical trial to evaluate the Absorb Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease. The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan.
Sinovac Biotech’s NDA for its proprietary EV71 vaccine has been accepted by the Beijing Drug Administration, which will conduct an on-site inspection of Sinovac’s clinical trials and submit its opinion along with the application documentations to the Centers for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA) for further review and evaluation.