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Merck’s anti-parasitic drug Stromectol (ivermectin) did not help speed recovery in patients with mild COVID-19, researchers in Cali, Colombia, found in a small clinical trial. Read More
The test showed it could detect a SARS-CoV-2 T cell mediated immune response in patients who tested positive for coronavirus, even when they had negative serology test results for antibodies. Read More
The assay runs on the company’s Alinity m system, a polymerase chain reaction (PCR) platform that that offers a turnaround time for assays of less than 115 minutes. Read More
As authorized COVID-19 vaccines are modified to protect against emerging strains of the pandemic disease, the UK will require only short clinical trials enrolling small numbers of volunteers to prove the altered vaccines are safe and effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
Germany’s CureVac has partnered with pharma giant Novartis to potentially manufacture hundreds of millions of doses of the small company’s COVID-19 vaccine candidate, CVnCoV, which is now under review by the European Medicines Agency (EMA). Read More
The European Medicines Agency (EMA) has begun a rolling review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Research Institute, but the European Commission doesn’t appear in a rush to secure doses. Read More
The Government Accountability Office (GAO) released a new report yesterday warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools and address its lack of foreign inspections as soon as possible. Read More
More than two months after Turkey granted emergency approval for the COVID-19 vaccine made by China’s Sinovac Biotech, Turkish researchers have revised the efficacy rate of the shot in preventing COVID-19 to 83.5 percent from 91.25 percent based on finalized phase 3 data. Read More
Polish biotech Mabion has inked a deal to make batches of the antigen Novavax’s COVID-19 vaccine candidate uses as an initial step toward a potential manufacturing contract. Read More
Vir Biotechnology and GlaxoSmithKline (GSK) announced yesterday that they will stop enrolling participants in a U.S. trial arm evaluating their COVID-19 antibody treatment, VIR-7831, which is part of a larger phase 3 study assessing potential coronavirus therapeutics being conducted by the National Institutes of Health (NIH). Read More
The FDA has issued a warning letter to HealthQuilt, the sponsor of a clinical trial evaluating a drug product as a COVID-19 treatment, citing its failure to submit an Investigational New Drug (IND) application for the product being studied, among other problems. Read More