SAN DIEGO – Predictions at the International Conference on Antimicrobials and Chemotherapy and the International Congress of Chemotherapy (ICAAC/ICC) 2015 annual meeting tend to be of the dire sort, warning of a return to the pre-penicillin era. So it was a pleasant exception to listen to Glaxosmithkline plc’s Rino Rappuoli brim with optimism during his plenary talk on challenges and opportunities of vaccines.
SHANGHAI – Zai Lab Ltd., located in the well-known Zhangjiang Hi-tech Park, has inked a deal with UCB SA, of Brussels, licensing global rights to its first large molecule asset, set to go into phase I trials in 2016.
Mesoblast Ltd., of Melbourne, Australia, said its licensee, JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan, received full approval from Japanese regulators for Temcell HS injection (JR-031), an allogeneic mesenchymal stem cell product, for treating children and adults with acute graft-vs.-host disease.
Cytori Therapeutics Inc., of San Diego, appointed John D. Harris vice president and general manager of cell therapy, effective Oct. 1. Harris will be based in Tokyo.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported that the FDA has granted priority review status to the new drug application for ixazomib, the first investigational oral proteasome inhibitor for the treatment of patients with relapsed or refractory multiple myeloma. Patients in the company’s pivotal phase III trial, TOURMALINE-MM1, continue to be treated to progression in this trial and will be evaluated for long-term outcomes.
TOKYO – A series of reforms over the past year by Japan’s PMDA have cut down approval times, improved the level of science regulators expected to review drug and medical device applications and helped Japanese authorities strengthen ties with their peers around the world. Those efforts, and others, are aimed at positioning the country as a regulatory leader in Asia.
HONG KONG — A new Japanese and U.S. collaborative study showing that inhibition of the oxygen sensor prolyl hydroxylase domain-containing protein 2 (PHD2) in the liver enhanced uptake of lactate for glucose production and ameliorated lactic acidosis, suggests that PHD2 may be a viable new therapeutic target for patients with life-threatening lactic acidosis.
SHANGHAI – Sciclone Pharmaceuticals Inc. is one of a few U.S.-listed specialty pharma companies almost exclusively focused on the China market. CEO Friedhelm Blobel sits in Foster City, Calif. – to be close to investors and shareholders – but he frequently finds himself on a plane to China, the main market for Sciclone’s oncology, infectious disease and cardiovascular therapies.
Gencia LLC, a nine-person biotech based in Charlottesville, Va., made an auspicious debut on the biotech stage with a potential $500 million deal with Takeda Pharmaceutical Co. Ltd. to develop a class of small-molecule drugs called mitochondrial agonists of the glucocorticoid receptor, or MAGRs. Gencia said its compounds may offer the benefits of conventional glucocorticoids but with improved potency and safety.
NEW DELHI – An increasing number of Chinese and Indian pharma firms are setting up units in each other’s countries, looking to tap into expertise and strength that may be lacking at home.