The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Biogen, Neurizon, Recce, Samsung.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: ARS, Alk-Abello, Alfreso, Atsena, Biocytogen, Biontech, Biotheus, CSL, Ideaya, Kaken, Nippon Shinyaku, NS Pharma, Numab, Pediatrix, Qilu, Theravance, Viatris
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.
Biopharma financing continued to excel through the first 10 months of 2024, reaching $93.64 billion, a 53% increase from $61.04 billion during the same period in 2023.
University of Auckland senior research fellow Jeff Smaill first visited China in 2012 as part of a team of 15 scientists from the Maurice Wilkins Center, one of New Zealand’s centers of excellence, to meet with scientists at the Guangzhou Institute of Medicine and Health to find partners to collaborate on drug development projects. The scientists started collaborating that year, and the first project is already in phase I trials in China. It was a joint discovery and development partnership from the beginning, he said.
Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales.
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