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More than 100 nongovernmental organizations (NGOs) have urged the World Trade Organization (WTO) to extend a waiver of intellectual property rights to help developing nations access COVID-19 treatments and vaccines during the pandemic. Read More
The FDA is unlikely to help Merck’s chances of getting a positive recommendation from the agency’s Oncology Drugs Advisory Committee today for its blockbuster drug Keytruda (pembrolizumab) for a new indication. Read More
Pfizer said it can cut the time it takes to manufacture its COVID-19 vaccine by almost half from 110 days to an estimated 60 days, a change that should significantly increase the speed of U.S. vaccinations. Read More
Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More
Despite new study findings suggesting that the AstraZeneca (AZ)/University of Oxford COVID-19 vaccine provides only “minimal protection” against mild-to-moderate infection from the South African variant, Western governments still have faith in the vaccine as a valuable weapon against the pandemic. Read More
The FDA has revised its Emergency Use Authorization (EUA) for COVID-19 convalescent plasma, allowing only plasma with high antibody titers and only for hospitalized patients with early infections or patients with impaired immunity. Read More
Merck’s anti-parasitic drug Stromectol (ivermectin) is being studied in multiple clinical trials as a potential COVID-19 treatment, but — at least for now — the company is warning against its use. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s antibody cocktail as a potential treatment for COVID-19 patients who don’t require supplemental oxygen and are at high risk of progressing to severe disease. Read More
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Read More