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Indian drugmaker Bharat Biotech has announced that its COVID-19 vaccine candidate, Covaxin (BBV152), proved to be 80.6 percent effective in the initial interim analysis of its late-stage clinical trials. Read More
Merck is planning to launch a new late-stage trial of an experimental COVID-19 treatment, MK-7110 (CD24Fc), because the previous phase 3 study enrolled too few participants to support regulatory clearance from the FDA. Read More
The device is meant to be used as an aid in identifying patients who have an adaptive immune response to the coronavirus in order to detect recent or prior infection. Read More
The European Medicines Agency and Health Canada have both moved to publish the full clinical data they reviewed and found sufficient for authorizing Moderna’s COVID-19 vaccine. Read More
The NIH announced that it has halted a clinical trial evaluating COVID-19 convalescent plasma as a treatment for mild-to-moderate COVID-19 patients placed in emergency departments. Read More
As the global COVAX vaccine-sharing program ramps up distribution, the organization has announced plans to deliver 237 million doses of AstraZeneca/Oxford University’s COVID-19 vaccine to 142 nations by the end of May. Read More
To speed the rollout of COVID-19 vaccine doses, the European Commission (EC) is considering an emergency approval mechanism in lieu of its more time-consuming and stringent conditional marketing authorization process. Read More
With Johnson & Johnson struggling to meet its COVID-19 vaccine supply commitments for the U.S., pharma titan Merck will provide its support to ramp up manufacturing of the one-shot vaccine, the Biden administration said Tuesday. Read More
The World Health Organization’s (WHO) guideline development group has issued a strong recommendation against using the anti-inflammatory malaria drug hydroxychloroquine to prevent COVID-19 infection. Read More
The European Medicines Agency (EMA) is reportedly conducting an audit that could conclude this month of the Serum Institute of India (SII), the largest vaccine manufacturer in the world, as the EU faces delays to AstraZeneca (AZ)/Oxford’s COVID-19 vaccine shipments. Read More
The U.S. has begun vaccinations with Johnson & Johnson’s (J&J) single-dose vaccine following the FDA’s authorization over the weekend but confronting a small initial rollout the drugmaker is accelerating dose production and working with multiple manufacturers in the U.S. and at sites in Europe, India and South Africa to meet its supply commitments. Read More
From March to October 2020, during the height of the COVID-19 pandemic, the FDA conducted just 52 domestic on-site pharmaceutical inspections and all but halted foreign inspections ― moves that have worried some regulatory experts. Read More