Seagen Inc. and Remegen Co. Ltd. will collaborate to exclusively develop and commercialize disitamab vedotin, a humanized antibody-drug conjugate (ADC) targeting HER2, giving Remegen the chance to earn up to $2.4 billion in total milestone payments. Read More
The new case of myelodysplastic syndrome (MDS) that overshadowed Bluebird Bio Inc.’s earnings and resulted in a clinical hold by the FDA will be addressed similarly to an earlier hitch in the sickle cell disease program, said Andrew Obenshain, the company’s head of severe genetic diseases. “Essentially, we will try and do the same thing,” and exonerate the lentiviral vector, he said during a conference call with investors. “At this point, we don't have tumor cells or leukemia to analyze,” he noted. Read More
Shares of Axsome Therapeutics Inc. (NASDAQ:AXSM) hit a 52-week low on Aug. 9, falling 46.5% to close at $24.37, after the FDA said deficiencies in an NDA in major depressive disorder for its drug, AXS-05 (dextromethorphan + bupropion), would "preclude labeling discussions" for now. Read More
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial. Read More
LONDON – Mission Therapeutics Ltd. has honed down a collection of 100-odd deubiquitylating (DUB) enzymes, to identify two that degrade misfolded proteins in Parkinson’s and Alzheimer’s diseases, triggering a $20 million milestone from partner Abbvie Inc. Read More
LONDON – Newco Macomics Ltd. has closed its first financing round at £7.4 million (US$10.3 million), enabling it to lay the ground for a new approach to addressing immunosuppression in the tumor microenvironment by modulating disease-specific macrophages. Read More
Cell therapy company Zhuhai Grit Biotechnology Inc. completed a series A+ financing of undisclosed value to advance its lead tumor-infiltrating lymphocyte (TIL) program, GT-101 for advanced solid tumors, into the clinic by year end while also developing other TIL candidates in its pipeline. Read More
Tobacco firm Philip Morris International Inc. has announced another acquisition as it adopts a “beyond nicotine” strategy, snapping up Otitopic Inc., of Los Angeles, for an undisclosed sum. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Athersys, Dicerna, Healios, Innovent, Neurocrine. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Algernon, Altamira, Antengene, Aop, Athersys, Bioinvent, Consynance, CSL, Eagle, Harmony, Healios, Ichnos, Inflammasome, Ji Xing, Merck, Mindrank, Ocular, Oyster Point, Regeneron, Syntrix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Aprea, Immvira, Polpharma, Spectrum. Read More
