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Prominent medical journal The Lancet has tightened its publishing requirements for research papers in response to an embarrassing retraction of a study based on questionable data from multiple trials. The journal said it will now require stronger data reviews for papers based on large, real-world datasets. Read More
AstraZeneca has released the trial protocols for the late-stage study of its coronavirus vaccine candidate, AZD1222, amid mounting calls for transparency as its investigation into an adverse event continues. Read More
A separate phase 3 trial previously found that the rheumatoid arthritis drug failed to provide a benefit for hospitalized COVID-19 patients with severe pneumonia. Read More
Roche’s late-stage COVID-19 trial of Actemra (tocilizumab) showed the rheumatoid arthritis drug reduced the number of coronavirus patients who progressed to mechanical ventilation, suggesting it might be of benefit as a coronavirus treatment although the drug did not meaningfully lower mortality rates. Read More
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