With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allarity, Arrowhead, Beigene, Kairos, Maia, Medison, Myrtelle, Pepgen, Quoin, Wesana.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: APR, Betterlife, Biogen, Biotech Acquisiton, Blade, Boston Children’s Hospital, Catalyst, Clovis, Corium, Edigene, Evergreen, Hemogenyx, Kahr, Kempharm, Linkinvax, Nanomerics, Nospharm, Qualigen, Redhill, Relief, Sanofi, Seagen, Virpax.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Almirall, Ascletis, Biogen, Biomed, Eisai, Enochian, Eyenovia, Gain, Iaso, Imugene, Innovation, Krystal, Merck, Ovid, Passage, Periphagen, Scripps Research, University of Michigan.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Adamis, Ascendis, Biogen, BMS, Bridgebio, Cansino, Faron, Fulcrum, Moderna, Nektar, Novartis, Pfizer, Sanofi, Solid.

Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Beigene, Hoth, Immunome, Oncternal, Orion, SGC Cell Therapy, Valneva.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aikido, Aikomi, Altamira, Arctoris, Arena, Ascletis, ATCC, Avadel, Bright Minds, Catalyst, Calliditas, Chemomab, Concert, Enzolytics, Evariste Technologies, Everest Medicines, Gelmedix, HTL, Ideaya, Index, Kye, Liminal, Neubase, Neximmune, Nuclixbio, Oncoarendi, Pharmabcine, Pfizer, Sandoz, Siwa, Small, Sumitomo Dainippon, Synthetic Biologics, VCN Terran, Virogentics.