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.
Boston Scientific Corp. has said pressure from the Delta variant in the U.S. means it is unlikely to hit the lower end of its current third-quarter sales guidance, which calls for 12% to14% organic growth vs. Q320 and 5% to 7% organic growth vs. Q319. Boston Scientific said it expected to still hit the full year sales guidance of 6% to 7% organic vs. 2019 that it issued on July 27 but would continue to monitor the economic and financial impacts of COVID-19. The company noted that the impact of Delta had been mostly in the NW and SE parts of the U.S. while the impact in EU/APAC region had been more modest.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytodyn, Geneuro, Moderna, Sellas Life Sciences, Strongbridge, Twist, Ventus, Xeris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Appili, Ascendis, Ayala, Bellus, Cytovation, Daré, Horizon, Immunocore, Nicox, Novan, Point, TFF, Valneva.
CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications. The findings, along with others, could form the basis of an inhaled biologics treatment for COVID-19 and, ultimately, other respiratory diseases.
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