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BioWorld - Saturday, April 1, 2023
Home » Topics » Infection » Coronavirus

Coronavirus
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FDA urges makers of tests marketed under COVID-specific policies to waste no time

March 31, 2023
By Mark McCarty
No Comments
With the public health emergency for the COVID-19 pandemic rapidly winding down, the U.S. FDA has published guidance for the transition of COVID-specific diagnostic tests and other articles to conventional premarket review mechanisms.
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Benefits of recombinant COVID-19 vaccine Bimervax outweigh risks, EMA finds

March 31, 2023
By Caroline Richards
No Comments
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
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In the clinic for March 30, 2023

March 30, 2023
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Affimed, Biogen, Bioxytran, Caribou, Corcept, Evaxion, Harmony, Netris, Precigen, Rapt.
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Free access to BioWorld coronavirus articles

March 30, 2023
No Comments
The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added three critical tables, which are continuously updated:

Vaccines and therapeutics in development
Diagnostics with U.S. FDA emergency use authorization
Clinical trials of biopharma products affected by COVID-19
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US agencies pressed on shortages, research and patent thickets

March 29, 2023
By Mari Serebrov
No Comments
U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
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Pros and cons of broader COVID-19 IP waiver aired at USITC hearing

March 29, 2023
By Mari Serebrov
No Comments
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
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Infection

Hokkaido University and Shionogi & Co. jointly develop Mpro inhibitors for SARS-CoV-2 infection

March 29, 2023
No Comments
Hokkaido University and Shionogi & Co. Ltd. have prepared bicyclic nitrogen-containing...
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In the clinic for March 28, 2023

March 28, 2023
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Baudaxbio, Eyepoint, Imvax, Ionis, Janssen, Neuraly, Novartis, Novo Nordisk, Nrx, Ocugen, Olix, TME, Unity, Yishengbio.
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Creative rendition of SARS-CoV-2 virus particles.
Biomarkers

Nasal anti-CD3 antibody targets T cells to reduce COVID-19-associated inflammation

March 28, 2023
No Comments
COVID-19 complications involve activated T cells that contribute to inflammation. Foralumab, a fully human anti-CD3 monoclonal antibody, targets the T-cell receptor and regulates T-cell function to suppress inflammation. In a pilot trial, foralumab reduced lung inflammation, serum IL-6 and C-reactive protein in cases of moderate COVID-19.
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China gives conditional nod to Zhongsheng’s COVID-19 oral pill

March 27, 2023
By Doris Yu
No Comments
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro).
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