Sosei Heptares and Eli Lilly and Co. have signed a potential $731 million deal to discover, develop and commercialize small molecules that modulate G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases. Read More
Astellas Pharma Inc. reported top-line results showing zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint for progression-free survival as well as secondary endpoints for overall survival in the phase III Glow trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Read More
Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell. Read More
Innovent Biologics Inc. has in-licensed LG Chem Ltd.’s tigulixostat (LC-350189), a late-stage non-purine xanthine oxidase inhibitor for managing chronic hyperuricemia in patients with gout, in a deal worth up to $95 million. Read More
3D Medicines Inc. has raised HK$408 million (US$52.5 million) in a listing on the Hong Kong Stock Exchange. Its shares opened at HK$29 apiece, jumped by more than 20% by the middle of the day, and closed at HK$31.45 on the first trading day of Dec. 15. Read More
Pediatrix Therapeutics Inc. licensed exclusive China rights to Aclaris Therapeutics Inc.'s ATI-1777 for investigational “soft” JAK 1/3 inhibitor, for diseases including atopic dermatitis, in exchange for an up-front payment of $5 million and up to $91 million in milestones. Read More
Chinese authorities this year for the first time allowed access for complete U.S. Public Company Accounting Oversight Board (PCAOB) audit inspections and investigations of PCAOB-registered public accounting firms headquartered in China and Hong Kong, in accordance with U.S. securities law. Read More
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components. Read More
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance. Read More
Data presented at the American Society of Hematology annual meeting and exposition, including: Alphamab Oncology, Aptose, Ascentage, Astrazeneca, Beigene, Carsgen, Junshi, JW, Starpharma, Tessa. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Actinogen Medical, Alphamab Oncology, Ascletis, Asieris, Aslan, Astellas, Bioved, Recbio Technology, Tessa. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: 1st, Biontech, Biosyngen, Carina, Casi, Eli Lilly, Jacobio, Moderna, Pfizer, Recce, Remegen. Read More
