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BioWorld - Thursday, February 19, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Sept. 28, 2021

Sep. 28, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
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Long COVID study suggests new symptoms months after initial infection

Sep. 28, 2021
By Nuala Moran
LONDON – A large-scale analysis of U.S. data shows that 57% of patients with a recorded diagnosis of COVID-19 subsequently presented to their physicians with symptom(s) of long COVID.
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Bat
Anything but BANAL

Close SARS-CoV-2 relative strengthens natural origin theory

Sep. 28, 2021
By Anette Breindl
Horseshoe or Rhinopolus bats in Laos carry coronavirus species with a near-identical receptor binding domain to SARS-CoV-2, according to a paper posted on the preprint server Research Square by investigators from the Pasteur Institutes of Paris and Laos.
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Child getting a shot

Pfizer-Biontech heads for an EUA request for vaccinating children against COVID-19 while the competition languishes

Sep. 28, 2021
By Lee Landenberger
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.
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Regulatory actions for Sept. 28, 2021

Sep. 28, 2021
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.
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Other news to note for Sept. 28, 2021

Sep. 28, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adial, Arrowhead, Biocytogen, Biovaxys, Bone, Bostongene, Cue, Diaprost, Eli Lilly, Envigo, Genelux, Implant, Janssen, J&J, Kannalife, Life, Lobe, Mitochon, Neuropathic, Newsoara, Pancella, Radiopharm, Signalchem, Sinopia, Viewpoint Molecular.
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In the clinic for Sept. 28, 2021

Sep. 28, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acasti, Acurx, ADC, Anheart, Aslan, Astrazeneca, Biohaven, Blue Lake, Cyanvac, Evelo, Harbour, Hua, Innovent, Intra-Cellular, Janssen, JW, Merck, Nrx, Pfizer, Phathom, Pulmotect, RDIF, Senhwa, Tyme.
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3D illustration of heart cross section

EACH lobbies for comprehensive EU cardiovascular disease policy

Sep. 27, 2021
By Nuala Moran
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.
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3D dollar sign

My Next Health gathers $150M capital from private investment group

Sep. 27, 2021
By Catherine Longworth
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.
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Equity needed for COVID-19 therapies, as well as vaccines

Sep. 27, 2021
By Mari Serebrov
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.
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