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BioWorld - Saturday, June 13, 2026
Home » Topics » Infection » Coronavirus

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Regulatory front for Feb. 24, 2021

Feb. 24, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA sees need for clarification of test coverage; MITA seeks transparency at USPSTF; NIH eyes license for cancer therapy; GAO says federal agencies falling short on recommendations; TGA updates guidance for risks in drugs and devices.
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Regulatory front for Feb. 24, 2021

Feb. 24, 2021
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Feb. 24, 2021

Feb. 24, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Antengene, Kura, Pfizer, RDIF, Teleflex.
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Other news to note for Feb. 24, 2021

Feb. 24, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcresta, Addex, Allarity, Beijing Tide, Cybrexa, Cyprium, Daiichi Sankyo, Decibel, Enamine, Generex, Graviton, Inovio, Insilico, Merck, Mydecin, Neonmind, Onconova, Pan-Biome, Poxel, Qiagen, Recce, Regeneron, Roivant, Sentinyl.
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In the clinic for Feb. 24, 2021

Feb. 24, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Click, Constant, Gtreebnt, Locus, Longeveron, Marinomed, Nanoform, Neurorx, Novavax, Opthea, Otsuka, Regentree, Salarius, Takeda, Theralase, Theravance.
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J&J's COVID-19 vaccine Ad26.COV2.S

One upmanship? J&J’s COVID-19 single-shot vaccine shortish on efficacy, long on other benefits

Feb. 24, 2021
By Randy Osborne
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
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Nexus IB10 being used in the lab

Sphingotec positions biomarker assays as personalized medicine tools in sepsis

Feb. 23, 2021
By Mary Ellen Schneider
Diagnostics company Sphingotec GmbH is looking to break into the U.S. market with a pair of biomarker assays that could help determine the best treatment for critically ill patients at risk for septic shock. The two assays, which are run on the company’s point-of-care Nexus IB10 immunoassay platform, measure bioactive adrenomedullin (bio-ADM), a hormone that maintains endothelial function; and dipeptidyl peptidase 3 (DPP3), an enzyme that inactivates angiotensin II when released into the blood.
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Smartphone showing Vocalis mobile app

Speak up! Voice sample provides accurate screen for COVID-19

Feb. 23, 2021
By Annette Boyle
"Step up, speak up" could be the next mantra for COVID-19 screening at airports, universities and large employers if Vocalis Health Inc.'s screening tool takes off – and its recent CE mark approval makes that more likely. Vocalis reported that a large study found the tool, which uses AI-powered vocal biomarkers, had greater than 80% sensitivity and specificity, even in asymptomatic individuals.
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Xavier Becerra, HHS secretary nominee

Price transparency emphasized in Becerra’s first Senate hearing for HHS job

Feb. 23, 2021
By Mark McCarty
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice.
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Coronavirus vaccine/therapeutics illustration

China pushes on with vaccine efforts, with 16 candidates approved for trials

Feb. 23, 2021
By David Ho
HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.
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