New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology Genitourinary Cancers Symposium, including Astellas, Eisai, Merck, Seagen.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Adamis, AIM Immunotech, Altimmune, Astellas, Astrazeneca, Beigene, Biontech, Celltrion, Curocell, Cytocom, Daiichi Sankyo, Dr. Reddy’s, Janssen-Cilag, JCR, Johnson & Johnson, Junshi, Pfizer, Pharmamar, RDIF, Seagen.
CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern.
HONG KONG – Beijing-based Beigene Ltd. struck its second deal outside China this year, signing an option and license agreement with Boston Immune Technologies & Therapeutics Inc. (BITT) for the latter’s tumor necrosis factor receptor 2 (TNFR2) antagonist antibodies.
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones.
HONG KONG – Ferring Pharmaceuticals’ microbiome-focused subsidiary Rebiotix Inc. and Mybiotics Pharma Ltd. have agreed to a multiyear strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
RSS
