Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Accutar, Amniotics, Ascletis, Beigene, Cansino, Glaxosmithkline, Henlius, Ilias, Innovent, Junshi, JW, Novartis, Novavax, Roche, Sellas, Serum Institute, Tonix, Triastek, Vir.
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Antengene, Coherus, Junshi.
NEC Corp. subsidiary NEC Oncoimmunity AS recently received $4.8 million from the Coalition for Epidemic Preparedness Innovations to fund the development of vaccines for SARS-CoV-2 variants and other betacoronaviruses.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
The China Securities Regulatory Commission has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. The draft rules specified the requirement for the overseas-listed companies and relevant securities service providers to disclose confidential materials in overseas offerings and listing.
Everest Medicines Ltd. has formed a partnership with China Resources Pharmaceutical Group (CR Pharma) to co-launch an independent company to focus on the development of messenger RNA (mRNA) vaccines.
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million.
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