Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astellas, Atara, BMS, Eisai, Genetx, Immunoforge, JW, Kintor, Lipidor, Moderna, Opko, Takeda, Transcenta, Ultragenyx, Vifor.
LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease.
Precision medicine company My Next Health Inc. (MNH) has guaranteed a $150 million equity capital commitment from Global Emerging Market (GEM), a $3.4 billion Luxembourg-based private investment group. MNH was formed in May 2020 due to a merger between functional genomics company The DNA Company and digital therapeutics platform My Pain Sensei. The New York-based company is developing genomics-based health management applications that offer patients personalized genetic insights.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astex, Astrazeneca, Capricor, Glycomimetics, Innovent, Kyowa Kirin, Novavax, PTC, Reven, Roche, SAB, Sarepta, Scholar Rock, TG, Vtv.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amplitude, Askgene, Aviceda, Bio-Thera, Camp4, Chemomab, China Medical System, D&D, Daré, Destiny, Eli Lilly, Eyevensys, Genscript, Gtreebnt, HLB, Intract, Jasper, Leeds University, Minnetronix, Mosaic, Novo Nordisk, Pharmacyte, Phillips-Medisize, Regenerx, Reveragen, SAB, Salubris, Santhera, University of Georgia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Baxter, RDIF, Regeneron, Roche, Sensorion, Spero.
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