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BioWorld - Friday, May 1, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Jan. 12, 2023

Jan. 12, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diacarta.
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In the clinic for Jan. 12, 2023

Jan. 12, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications:  Aclaris, Alvotech, Aprea, Bexion, Bio4t2, Bioxcel, Glaukos, Grifols, Hemab, Hightide, Lipella, Nascent, Panbela, Prokidney, Zenas.
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Moderna vaccine vial and syringe on tray

No US price increases for COVID-19 vaccine, new HELP chair tells Moderna

Jan. 11, 2023
By Mari Serebrov
Sen. Bernie Sanders (I-Vt.), the incoming chair of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, penned a blistering letter that takes Moderna Inc. CEO Stéphane Bancel to task over the company’s plans to more than quadruple the U.S. list price of its COVID-19 vaccine once the government’s supply is depleted.
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Coronavirus, lungs

UK scientists translating COVID sequencing efforts to monitor respiratory infections

Jan. 11, 2023
By Nuala Moran
The success of the U.K. COVID-19 genomics consortium in large-scale sequencing, tracking variants of concern, establishing rates of transmissibility and informing public health decision-making during the pandemic, is to be extended to the monitoring of other respiratory viruses.
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Paxlovid

China drops Paxlovid coverage despite rising COVID cases

Jan. 11, 2023
By David Ho
China's National Healthcare Security Administration will not be adding Pfizer Inc.'s COVID-19 treatment Paxlovid to its list of medicines covered by basic medical insurance schemes in the country, due to its high prices.
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Regulatory actions for Jan. 11, 2023

Jan. 11, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medmira, MTD.
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In the clinic for Jan. 11, 2023

Jan. 11, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acticor, Alterity, Alto, Biofrontera, Genethon, Glycomine, Innovent, Insilico, Journey, Pieris, Rocket, Sutro, Union, Vistagen, Vyne.
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Person using COVID-19 antigen test at home

FDA hits COVID test maker for lack of marketing authorization, quality management lapses

Jan. 10, 2023
By Mark McCarty
U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned.
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Chinese flag and microscopes

China’s clinical trial landscape is evolving quickly toward innovation

Jan. 10, 2023
By Tamra Sami
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
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China grants emergency use authorization for Merck’s COVID-19 drug

Jan. 10, 2023
By Doris Yu
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
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