Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01. Read More
Abpro Corp. is making another attempt to go public, this time by merging with Atlantic Coastal Acquisition Corp. II. The merger would put Abpro’s company value at $725 million. Atlantic Coastal is a special purpose acquisition company (SPAC) that went public in January 2022. Its stock (NASDAQ:ACAB) closed Sept. 22 at $10.63 per share. Read More
The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million). Read More
Wuhan YZY Biopharma Co. Ltd. made its debut on the Hong Kong Stock Exchange, raising HK$121 million (US$15.48 million) in its IPO on Sept. 22, with shares (HKEX:02496) opening at the lower end of its range at HK$16 per share and ending the day at HK$16.60, a rise of 3.75%. Read More
Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Apnimed, Cybin, Cymabay, Entrada, Gilgamesh, Lipella, Moleculin, Newamsterdam, Protara, Revolo, Sellas, Travere. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Conduit, Coya, Hillstream, Scilex, Sorrento. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Aligos, Disc Medicine, Dizal, Genprex, Immix, Krystal, Leucid, Mesoblast, Taysha Gene. Read More
