Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced that the FDA cleared the company to proceed with a Phase 3 clinical trial using the investigational EV drug ExoFlo to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19.
ReutersWorldwide 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.
The Chinese government halted the recommendation of an herbal supplement used as a traditional Chinese treatment for mild cases of COVID-19.
The 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.
Reuters HealthThe U.S. Food and Drug administration granted priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
Regeneron Pharmaceuticals Inc. on Feb. 4 reported fourth-quarter 2021 revenue that beat analysts’ estimates, boosted by demand for the blockbuster drugs Dupixent and Eylea, coupled with higher sales of the company’s COVID-19 therapy.
Novartis dropped out of the company’s deal to fund Mesoblast’s floundering COVID-19 treatment.
Samsung Biologics Co. Ltd. said on December 13 the company would continue its partnership with AstraZeneca Plc on manufacturing biopharmaceuticals.
Regeneron Pharmaceuticals Inc. reported a better-than-expected quarterly profit on May 6 and expects demand for the company’s Covid-19 antibody therapy to hold up even as vaccination efforts across the United States intensify.
GSK and Vir Biotechnology filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage Covid-19 infections, the drugmakers said on March 26.
