Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor. Read More
Zenas Biopharma LLC launched on March 23 as a U.S. funded cross-border biotech company targeting autoimmune diseases in China. The company, headquartered in Miromar Lakes, Fla., is founded and funded by Tellus Bioventures LLC and Fairmount Funds Management LLC. Read More
Eliem Therapeutics Inc. is old-fashioned in the useful ways. The company is going after extremely large indications, including chronic pain and major depression. “We’re really passionate about these large markets,” Eliem President and CEO Bob Azelby told BioWorld. “These patients live in the shadows… There’s so many people suffering.” Read More
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on phase II trial results, instead after the usual phase III trials. Read More
Arbutus Biopharma Corp. this month gained the go-ahead from regulators to start a phase Ia/Ib trial with its oral capsid inhibitor, AB-836, for the treatment of chronic hepatitis B virus (HBV) infection, an event that drew more attention to the busy space and brought renewed speculation about RNAi bids against HBV, including Arbutus’ own. Read More
Biopharmas raising money in public or private financings, including: Amplicore, Design, Edgewise, Gain, Gyroscope, Ikena, Phoremost, Summit, TFF, Universe, Windtree. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Acerus, Agios, Ajinomoto, Alvotech, Ascentage, Bright Peak, Brooklyn Immunotherapeutics, Dunad, Goliver, Haima, Intellia, Mitsubishi Tanabe, Novadiscovery, Open Orphan, Servier, Targeted Pharmaceuticals, Tetra Bio-Pharma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airway, Astellas, Biontech, Camurus, Diurnal, Gilead, Glaxosmithkline, Idorsia, J&J, Pfizer, Roche, Seagen, Takeda, Vertex, Vir. Read More
