In a bit of déjà vu, the U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee once again voted that Makena (hydroxyprogesterone caproate) should be withdrawn from the U.S. market while a second confirmatory trial is designed and conducted. But this time around, the committee’s 14-1 vote was much more decisive than its 9-7 vote in 2019. Read More
Jazz Pharmaceuticals plc in-licensed regional rights to Zymeworks Inc.’s HER2- targeted bispecific antibody zanidatamab in a deal potentially worth $1.76 billion, plus royalties. Jazz wants to expand its oncology portfolio with the deal, which covers the U.S., Europe, Japan and all other territories except Asia Pacific markets previously licensed by Zymeworks to Beigene Ltd. Read More
Nucleome Therapeutics Ltd. is poised to shed some light on the dark matter of the genome after raising £37.5 million (US$42.3 million) in an oversubscribed series A to begin commercialization of its technology for deciphering non-coding genes. Read More
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases. Read More
The U.S. FDA wants more data on PTC-518 before PTC Therapeutics Inc.'s phase II study of Huntington’s disease can continue enrollment. While stopped in the U.S., the study of the oral, small-molecule splicing modifier still is enrolling participants at sites in several European countries and in Australia. Read More
Biocytogen Pharmaceuticals Co. Ltd. subsidiary Eucure Biopharma Co. Ltd. has formed a partnership with Syncromune Inc. to combine Eucure’s YH-002 and two other active ingredients with Syncromune’s Syncrovax platform technology in a deal the partners said could be worth “hundreds of millions of U.S. dollars,” including an up-front cash payment of undisclosed value. Read More
New hires and promotions in the biopharma industry, including: Anheart, Anokion, Bright Peak, Inversago, Orionis, Rewind, Senda, Theseus, Valirx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaxis, Alvotech, Ambrx, Ayala, Clarus, Insmed, FDA, Galecto, ITM, Jamp, Kamada, Kintara, Nanobiotix, Shionogi, Tolmar. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: .Amryt, Carsgen, Intelgenx, Jaguar, Kite, Kyverna, Lexeo, Nkgen, Noema, Prelude, Roche, Vitti, Zhiyu. Read More
