HONG KONG — Combining suppression of stemness with lineage-specific induction using a newly developed sequential treatment protocol leads to the successful conversion of pluripotent stem cells (PSCs) into functioning neurons for potential use in regenerative medicine, a study by Korean researchers has found. Read More
The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade. Read More
SHANGHAI – Zai Labs Ltd., of Shanghai, signed a China rights deal, including Hong Kong and Macau, for a coveted late-stage targeted non-small-cell lung cancer (NSCLC) therapy, HM61713, from Hanmi Pharmaceuticals Co. Ltd., of Seoul, Korea. Read More
HONG KONG – Amgen Inc., one of the four largest U.S. biopharmaceutical companies, recently launched Amgen Korea, a move that coincided with the go-ahead to market two cancer drugs in the country. Read More
NEW DELHI – India's Central Drugs Standards Control Organisation (CDSCO) issued a slew of notifications in November aiming to speed up clinical trial approvals following concerns from companies that many regulatory requirements are duplicated and often tedious. Read More
Plans to launch the first biosimilar of Enbrel (etanercept, Amgen Inc.) in Europe are taking a big step forward with receipt by Samsung Bioepis Co. Ltd. of a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). If approved by the European Commission (EC) as expected, it would become the first subcutaneous anti-TNF biosimilar there. It is one of three Bioepis biosimilars that Biogen Inc. has rights to commercialize in the EU and other countries. Read More
HONG KONG – The Malaysian government is setting a five-year data protection structure for biologics in the country under the terms of the Trans-Pacific Partnership (TPP). That could mean more expensive drugs for the people and better protection for drugmakers. Read More
Nitto Denko Corp., of Osaka, Japan, reported preliminary results from ongoing phase Ib/II studies showing that ND-L02-s0201, its targeted siRNA lipid nanoparticle, was well tolerated in advanced fibrosis patients, with histological improvement of fibrosis observed. ND-L02-s0201 has been granted two FDA fast track designations for non-alcoholic steatohepatitis and hepatitis C virus liver fibrosis. Read More
HONG KONG – 3Sbio Inc., a biopharmaceutical company that has returned to a stock market in China after delisting abroad, has now taken a further step in its newfound home market by acquiring shares of a leading biosimilar monoclonal antibody (MAb) maker as part of an effort to build the largest biological drug platform in China. Read More
