China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascletis, Delta-Fly, Moleculin, Novavax, Oncopeptides, Qualigen, Sionna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abiogen, Actinium, Altamedics, Addex, Daiichi Sankyo, Entrada, Gilead, Indivior, Instil, Kite, Revolution, Sanofi, Sensei, Sosei, Spikimm, Tevogen and Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Altavant, Clear Creek, Enzyvant, Equillium, Essential, Everson, Explorna, Hotspot, Intrinsic, Kyowa, MEI, Metrion, Nykode, Omnispirant, Ono, Pfizer, Replimune, Roche, Tris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzheon, Biovie, Cassava, Celldex, Dragonfly, Editas, Gossamer, Imaginab, Kinarus, Leo, Medicinova, Mirati.
Tetra Bio-Pharma Inc. has reported results from a study of ARDS-003 (onternabez) combined with favipiravir against acute respiratory distress syndrome (ARDS), sepsis and COVID-19 through PREPAiRE, an artificial intelligence (AI)-powered platform which integrates target identification, validation, lead discovery optimization, drug synthesis and preclinical testing.
Pfizer Inc. and Clear Creek Bio Inc. have entered into a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19.
The Coalition for Epidemic Preparedness Innovations (CEPI) has expanded its partnership with VBI Vaccines Inc. to advance the development of multivalent coronavirus vaccines that could be deployed against COVID-19 and possible future coronaviruses with pandemic potential, referred to as coronavirus X.
The world is emerging from the COVID-19 pandemic, as both cases and deaths have remained consistently low in recent months, despite continuous mutation of the SARS-CoV-2 virus. Nevertheless, there is a shuffling of candidates in the arsenal as new variants bump once-effective therapies and the next generation of options enter the arena.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Biogen, Hexaell, Ideaya, Idorsia, Pfizer, Protalix, Redhill, Syndax.