The latest global regulatory news, changes and updates affecting biopharma, including: NIH adds funding to Latino Alzheimer’s research; Sprout warned for Addyi promotion; Scripps to pay $10M over use of NIH grants.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Amryt, Apellis, Ardelyx, Astrazeneca, BMS, Boehringer, Epimab, Equillium, Gensight, Gilead, Kiniksa, Lilly, Mateon, Matinas, Novartis, Plus, Takeda, Zynerba.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adicet, Alimera, Anelixis, Applied Stemcell, Axovant, Bayer, Biontech, BMS, Bostongene, C3.ai, Cell and Gene Therapy Catapult, Cellinta, Combigene, Corino, Cullinan, Cue, ERS Genomics, Exelixis, Fosun, Genexine, Humanigen, Iconic, Innovation Pharma, Kiadis, Mabion, Medis, Melior, Mindset, Miragen, Momenta, Mylan, Novavax, Novus, Obsidian, Oligomerix, Pfizer, Protokinetix, Restorbio, Serum Institute of India, Soligenix, Systems Oncology, Teva, Tonix, Vaxine.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Aerpio, Arbutus, Atossa, Atyr, Axsome, Clinuvel, Codiak, Curasen, Curevo, Galecto, Kyorin, Marinus, Opko, Teva, TFF, Tyme.

HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.

LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.

The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABL, Accord, Acelrx, Aimmune, Arctoris, Astrazeneca, Biogen, Daiichi Sankyo, Evotec, Glycot, Hifibio, J&J, Keros, Lava, Marinus, Medigen, Molecular Partners, Moleculin, Molteni, Navire, Navrogen, Nestle, Neuraxpharm, Orexo, Pascal, Pfizer, Reveragen, Santhera, Sorrento, S?rse, Springworks, Starpharma, Syntekabio Takeda, Talaris, Tikomed, Vaxess.