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BioWorld - Monday, January 12, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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Regulatory actions for Sept. 27, 2021

Sep. 27, 2021
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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10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

Analysts lower Boston Scientific sales forecast following concerns over impact of Delta variant

Sep. 24, 2021
By Catherine Longworth
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.
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Other news to note for Sept. 24, 2021

Sep. 24, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytodyn, Geneuro, Moderna, Sellas Life Sciences, Strongbridge, Twist, Ventus, Xeris.
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In the clinic for Sept. 24, 2021

Sep. 24, 2021
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.
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CDC headquarters

Practical or political? CDC says frontline workers can get COVID-19 boosters

Sep. 24, 2021
By Lee Landenberger
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.
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COVID-19 vaccine vials

ACIP struggles with COVID-19 booster recommendations

Sep. 23, 2021
By Mari Serebrov
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.
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Science-James-Naismith-9-22

Inhaled antibodies brought to SARS-CoV fight

Sep. 23, 2021
By Anette Breindl
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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Other news to note for Sept. 23, 2021

Sep. 23, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocartis, BK Medical, Digital Therapeutics Alliance, Draper, Evoendo, Gamma Biosciences, GE Healthcare, Neuroone, Orasure Technologies, Roche Diagnostics Canada, Second Genome, Squid Healthcare, Theromics.
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saRNA newcomer Vaxequity lands Astrazeneca as partner

Sep. 23, 2021
By Nuala Moran
LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine.
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Regulatory actions for Sept. 23, 2021

Sep. 23, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Algernon, Arcturus, Bluebird, Carisma, Cytodyn, Incyte, Inovio, Inventiva, Moberg, Pharmamar, Radius Health, Rhythm, Taysha Gene Therapies, Tryp.
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