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BioWorld - Sunday, May 10, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Feb. 16, 2021

Feb. 16, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Aim Immunotech, Akan, Astrazeneca, Biontech, BMS, Celltrion, Cortexyme, Cytocom, Daiichi Sankyo, Forge Biologics, G1, Jazz, JCR, Pfizer, Pharmsynthez PJSC, Sesen, Signature, Sobi, Targovax, Xenetic.
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Other news to note for Feb. 16, 2021

Feb. 16, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Alkido, Anixa, Avexegen, Basilea, Beyond Air, Biomunex, Cannabics, Cend, Clearside, Enzolytics, Hikma, Moderna, Neuren, Nicox, Novavax, Oncoheroes, Onward, Qilu, Recce, Renibus, Sensorion, Shepherd, Tryp.
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In the clinic for Feb. 16, 2021

Feb. 16, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Adagio, Bluebird, Clene, Diffusion, Equillium, Gensight, Gyroscope, Histogen, Interna, Kodiak, Lysogene, Metacrine, Monopar, Neoimmunetech, Neuren, Noxxon, Realta, Recce, Regenxbio, Sagent, Synairgen.
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Coronavirus vaccine/therapeutics illustration

Tonix looks to the past for the future of COVID-19 vaccines and testing

Feb. 12, 2021
By Annette Boyle
Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine.
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COVID-19 vaccine vials behind U.S. capitol building
Pfizer, Moderna agree to deliver 200M more doses

House committee inks spending package for COVID-19 pandemic

Feb. 12, 2021
By Mark McCarty
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
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Mask with Brazilian flag

Seegene strengthens footprint in Latin America via COVID testing

Feb. 12, 2021
By Gina Lee and Sergio Held
COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.
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Regulatory actions for Feb. 12, 2021

Feb. 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson.
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Other news to note for Feb. 12, 2021

Feb. 12, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aziyo Biologics, Blackrock Microsystems, Clearpoint Neuro, Dexcom, Falcon, Mallinckrodt, Mrs Allergy, Nex Cubed, Picosun Oy, Sharecare, Spineway.
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BioWorld MedTech’s Neurology Extra for Feb. 12, 2021

Feb. 12, 2021
By Andrea Applegate and Anette Breindl
Keeping you up to date on recent developments in neurology, including: Understanding ‘brain fog’ in people with COVID-19; AD diagnostics could become more accessible; Careful with that BBB.
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Regulatory actions for Feb. 12, 2021

Feb. 12, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curevac, Immunitybio, Lysogene, Nantkwest, Regeneron, Seagen, Xeris.
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