Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents. Read More
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China. Read More
Sangamo Therapeutics Inc.’s second large, worldwide licensing deal for its capsid technology in the past five months is with Astellas Pharma Inc. The California-based company is getting $20 million up front and the chance to bring in up to $1.3 billion in fees and milestone payments in an agreement spanning five potential disease targets for gene therapies to treat neurological diseases. Read More
Clinical data reported by a handful of biopharmas on Dec. 19 sent stocks soaring or plunging, as company leaders laid out next-step plans. Investors showed enthusiasm for Omeros Corp.’s narsoplimab to treat hematopoietic stem cell-transplant-associated thrombotic microangiopathy (TA-TMA), and Roche AG’s Parkinson’s prospect prasinezumab, which is partnered with Prothena Corp. plc. Read More
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone. Read More
Ottimo Pharma Ltd. is equipped to file an IND and take its lead bifunctional antibody into phase II development, after closing a $140 million series A. The round will accelerate development of jankistomig, which targets the PD-1 immune checkpoint whilst inhibiting tumor angiogenesis by neutralizing vascular endothelial growth factor (VEGF). Read More
A principal investigator and a former biopharma executive are the latest to reach settlements with the SEC to resolve charges of insider trading involving drug companies. Sai-Hong Ignatius Ou, of the University of California Irvine, agreed to a judgment ordering him to disgorge more than $1.5 million and to pay a civil penalty of the same amount. In a separate, unrelated settlement, Curt Dewitz, a former executive of an undisclosed biopharma company, agreed to disgorge about $70,383 in unlawful profits. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alk-Abello, Aurion, Cognition, Corvus, Ena, Exegi, Hansa, Krystal, Metavia, Mendus, Quoin, Sensorion, Transcode, Viatris, Verastem. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cara, Clarity, Catalent, Eli Lilly, Grit, Holoclara, Inceptor, Novo Nordisk, Photys, Structure, Tvardi, Ultimovacs, Zelluna. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Celltrion, Eli Lilly, Johnson, Praxis. Read More
