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Eli Lilly and healthcare company UnitedHealth are working together to conduct a pragmatic study of the American pharma titan’s COVID-19 antibody treatment, bamlanivimab (LY-CoV555), a therapy that received Emergency Use Authorization (EUA) from the FDA nearly a month ago. Read More
Moderna is preparing to launch a new phase 2/3 trial in the U.S. to assess its promising coronavirus vaccine in adolescent participants aged 12 to 17, though it’s not yet clear when it will start enrolling volunteers. Read More
AstraZeneca’s (AZ) late-stage U.S. coronavirus vaccine trial is likely to have efficacy data in January that could be enough for the company to request Emergency Use Authorization (EUA), Operation Warp Speed’s chief adviser Moncef Slaoui said this week. Read More
Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday. Read More
The UK’s RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients. Read More
Moderna on Monday submitted a request for FDA Emergency Use Authorization (EUA) for its coronavirus vaccine, mRNA-1273, making it just the second company to date that’s taken a candidate far enough to file an application for emergency clearance. Read More
AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. Read More
German drugmaker BioNTech and China’s Fosun Pharmaceutical Group have announced that the Pfizer/BioNTech COVID-19 vaccine candidate, BNT162b2, will be evaluated in a phase 2 study in China, building on an agreement the companies signed in March. Read More