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Home » antivirals

Articles Tagged with ''antivirals''

Digital illustration of U.S., coronavirus

Demand for COVID-19 rapid tests may spike for use with FDA-approved therapies

Nov. 30, 2021
By Mark McCarty
While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.
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Earth threatened by virus

Omicron scrambles vaccine development as markets rise

Nov. 29, 2021
By Lee Landenberger
While the world grapples for a clear picture of the Omicron variant and how to handle it, Moderna Inc., Biontech SE and Adagio Therapeutics Inc. stepped out with stock advances, building on momentum from the end of last week, while eyeing 2022 as a launch date against the variant.
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Microscope and coronavirus illustration

Omicron a potential shadow over molnupiravir adcom

Nov. 29, 2021
By Mari Serebrov
With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections.
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Merck posts disappointing data from COVID-19 pill ahead of key FDA meeting

Nov. 29, 2021
By Richard Staines
Molnupiravir, the take-at-home pill from Merck & Co. Inc. hailed as a potential game-changer against COVID-19, is not as effective as previously thought, according to newly released trial data from the company.
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Virus and drug illustration

Roche steps away from COVID-19 development deal with Atea

Nov. 17, 2021
By Lee Landenberger
Roche Holding AG is walking away from a deal with Atea Pharmaceuticals Inc. to co-develop the COVID-19 oral antiviral treatment AT-527 after the mid-October failure of a global phase II study testing the medicine in non-hospitalized adults with mild or moderate disease missed its primary endpoint. Roche’s decision tosses the rights and licenses back to Atea so it can continue its development and commercialization efforts.
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Patient recruitment to stop in Molecular Partners’ COVID-19 phase III study of ensovibep

Nov. 16, 2021
By Lee Landenberger
A futility analysis of Molecular Partners AG’s ensovibep for treating hospitalized COVID-19 adults prompted an independent data safety monitoring board to recommend discontinuing recruitment of patients in the phase III ACTIV-3 study.
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Favipiravir falls short in Appili's phase III COVID-19 trial

Nov. 12, 2021
By Michael Fitzhugh
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said.
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Drug capsules in petri dish

Pfizer adds fresh evidence to EUA filing for new COVID-19 pill

Nov. 5, 2021
By Michael Fitzhugh
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
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Molnupiravir capsules

UK authorizes high-profile COVID-19 pill

Nov. 4, 2021
By Michael Fitzhugh
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
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Merck lurks after phase II Moonsong dirge; Atea’s COVID-19 Morningsky to brighten?

Oct. 19, 2021
By Randy Osborne
Phase II results from Atea Pharmaceuticals Inc. with AT-527 in COVID-19 treatment had pundits scrambling to stack the odds of success for the direct-acting oral antiviral against those of Merck & Co. Inc.’s molnupiravir, though cross-trial comparisons are beset by the usual hurdles, with two especially dramatic ones.
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