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The National Institutes of Health (NIH) has launched a phase 2 clinical trial of Rigel Pharmaceuticals’ fostamatinib for the treatment of hospitalized COVID-19 patients. Read More
Only 1.7 percent of participants given the antibody were later hospitalized for COVID-19 compared to 6 percent of those on placebo — a 72 percent reduction in the hospitalization risk. Read More
Pfizer reported early safety data yesterday from its phase 3 COVID-19 vaccine trial, saying the vaccine prompted mostly mild to moderate adverse reactions in patients. Read More
A mid-stage trial of Eli Lilly’s neutralizing COVID-19 monoclonal antibody LY-CoV555 found that the drug reduced the risk of hospitalization in mild-to-moderate COVID-19 patients by 72 percent compared to a placebo. Read More
Health regulators abroad have begun giving the OK for AstraZeneca to resume its phase 3 COVID-19 vaccine trial following a single unexplained patient illness, but the FDA has still not cleared the trial to start back up, with FDA Commissioner Stephen Hahn saying the agency will engage in “very significant work” with the company to unravel the safety issue. Read More
Sponsors of clinical trials for drugs or biologics to treat eosinophilic esophagitis, a chronic disease in which white blood cells inflame the esophagus, should note a change to how the FDA recommends they analyze the data. Read More
The head biosafety expert for China’s Center for Disease Control and Prevention has claimed that the country could have a vaccine ready for general population use as soon as November, touting the country’s rapid progress on COVID-19 vaccine development. Read More
The National Institutes of Health (NIH) is deeply concerned that an unexplained patient illness under review in AstraZeneca (AZ)’s phase 3 COVID-19 vaccine trial could throw the promising candidate off course, and the NIH has opened its own investigation into the issue, an NIH clinical director has disclosed. Read More
Neurocrine Biosciences has finally launched its once-daily Parkinson’s disease add-on treatment Ongentys (opicapone) in the U.S. following months of delay brought on by the COVID-19 pandemic. Read More