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BioWorld - Sunday, June 4, 2023
Home » Topics » Infection » Coronavirus

Coronavirus
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Now COVA is over, Biophytis vies for a piece of the COVID-19 pie

Feb. 2, 2023
By Caroline Richards
No Comments
Biophytis SA’s investigational treatment for hospitalized COVID-19 patients with severe disease, Sarconeos (BIO-101), reduced the risk of respiratory failure or early death by 44% compared to placebo, final data from a phase II/III COVA trial show, but with the disease not being quite the emergency it once was, the drug’s future could be on shaky ground.
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Regulatory actions for Feb. 2, 2023

Feb. 2, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agile, Artiva, Beactica, Edesa, Ellipses, Flag, Genoscience, Greenlight, Mesoblast, ONL, Roche, Taysha, Xortx.
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Other news to note for Feb. 2, 2023

Feb. 2, 2023
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Additional early-stage research and drug discovery news in brief, from: Engeneic, Sonnet Biotherapeutics, Transcode Therapeutics.
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Coronavirus, mRNA and syringe
Infection

Greenlight cleared to begin first-in-human study of mRNA COVID-19 vaccine candidate GLB-COV2-043

Feb. 2, 2023
No Comments
Greenlight Biosciences Holdings PBC has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a first-in-human phase I/II trial of its mRNA vaccine candidate against COVID-19, GLB-COV2-043, as a booster for previously vaccinated individuals.
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Biden administration to allow pandemic-driven public health emergency to end

Jan. 31, 2023
By Mark McCarty
No Comments
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
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Regulatory actions for Jan. 31, 2023

Jan. 31, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
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China approves two oral drugs to treat COVID-19

Jan. 30, 2023
By Zhang Mengying
No Comments
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
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Regulatory actions for Jan. 30, 2023

Jan. 30, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Argenx, Astrazeneca, Bioaegis, Bloomsbury, Bristol Myers Squibb, Eisai, Eli Lilly, Exegi, Ipsen, Merck, Orion, Regeneron, Sana, Sanofi, Viatris.
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Regulatory actions for Jan. 27, 2023

Jan. 27, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Centessa, Daewoong, Daiichi, Discgenics, Lapix, Syros, Valeo.
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Other news to note for Jan. 27, 2023

Jan. 27, 2023
No Comments
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acerus, Altamira, Celularity, F-star Immusoft, Inbox, Lighthouse Pharma, Liminal, Novavax, Quince, Senti, Sino, Siva, Sona.
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