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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

HONG KONG – Chinese pharmaceutical firms have come a long way, transforming themselves from makers of active pharmaceutical ingredients (APIs) to innovative drug developers in a couple of decades. The secret sauce in that transformation has been investment in R&D. Read More

HONG KONG – Marking another step in its path to profitability, South Korea’s Samsung Bioepis Co. Ltd. reported a first approval in its home market for a biosimilar – Brenzys – based on Amgen Inc.’s blockbuster Enbrel (etanercept) to treat arthritis. Read More