Pfizer initiates Phase 1 study of novel oral antiviral therapeutic agent against SARS-CoV-2
Pfizer Inc. (NYSE: PFE) announced that it is progressing to multiple ascending doses after completing the dosing of single ascending doses in a Phase 1 study in healthy adults to evaluate the safety and tolerability of an investigational, novel oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19.
Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks.
Some countries in the European Union have temporarily suspended use of the AstraZeneca COVID-19 vaccine as a precautionary measure based on reports of rare blood coagulation disorders in persons who had received the vaccine. Other countries in the EU - having considered the same information - have decided to continue using the vaccine in their immunization programmes.
Eli Lilly and Company (NYSE: LLY) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.
Novartis has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.