Worldwide demand for Pfizer Inc.’s oral COVID-19 antiviral treatment Paxlovid has been unexpectedly light due to complicated eligibility requirements, reduced testing and potential for drug interactions, a Reuters review of data and interviews with experts found.
U.S. FDA extends review of Biologics License Application for REGEN-COV (casirivimab and imdevimab) for treatment and prophylaxis of COVID-19
Biologics License Application (BLA), Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutic, COVID-19 Therapeutics, COVID-19 Therapies, FDA, Pandemics, Regeneron Pharmaceuticals, TherapeuticsThe U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the Biologics License Application (BLA) for Regeneron Pharmaceuticals Inc.’s REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
Roche Says U.S. FDA Grants Priority Review to Actemra for COVID-19
Business, Coronavirus Disease 2019 (COVID-19), Coronavirus Disease 2019 (COVID-19), COVID-19 antibody drugs, COVID-19 antibody therapy, COVID-19 Therapeutic, COVID-19 therapeutic candidates, COVID-19 Therapeutics, COVID-19 Therapies, FDA, Priority Review, R&D, Research & Development, TherapeuticsThe U.S. Food and Drug administration granted priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
Thirty five generic drugmakers around the world will make cheap versions of Pfizer Inc.’s highly effective COVID-19 oral antiviral Paxlovid to supply the treatment in 95 poorer countries, the U.N.-backed Medicines Patent Pool (MPP) said on March 17.
The U.S. Food and Drug Administration said on February 23 GlaxoSmithKline and Vir Biotech’s COVID-19 antibody treatment should not be used in places with circulation of variants that are not susceptible to the drug.
The Centers for Disease Control and Prevention (CDC) awarded Palantir Technologies Inc. a $5.3 million contract to manage distribution of COVID-19 drugs in the United States, the software maker said on February 22.
China’s medical products regulator said on February 12 it has given conditional approval for Pfizer’s COVID-19 drug Paxlovid, the first oral pill specifically developed to treat the disease to be cleared in the country.
Gilead says COVID drug remdesivir shows antiviral activity against Omicron, other variants
Antivirals, Clinical Data, Clinical Trials, Covid-19 Data, COVID-19 Therapeutics, Covid-19 Variants, Delta Variant (B.1.617.2; India), Gilead, Omicron (B.1.1.529) (South Africa), Omicron BA.2, R&D, Remdesivir, TherapeuticsGilead Sciences Inc.’s antiviral drug remdesivir showed antiviral activity against Omicron, Delta and other variants of the coronavirus in laboratory studies, the company said on February 11.
One month after posting positive Phase II data, Novartis and Molecular Partners are seeking Emergency Use Authorization from the U.S. Food and Drug Administration for ensovibep, a DARPin antiviral therapeutic candidate developed to treat COVID-19.
Merck & Co. expects the company’s 2022 sales to increase as much as 18 percent over 2021, mostly on sales of the new COVID-19 pill molnupiravir.