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Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced. 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 COVID-19 vaccine won’t be widely available nationwide until late in the second quarter or in the third quarter of 2021, Robert Redfield, director of the Centers for Disease Control and Prevention (CDC), said yesterday at a subcommittee hearing of the Senate Appropriations Committee. But President Trump disputes that timeline. 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
Two plans — one from Operation Warp Speed and one from the Centers for Disease Control and Prevention — for distributing a COVID-19 vaccine are short on crucial details and leaves much of the distribution to state and local authorities. 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
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
The FDA has hit Mallinckrodt Pharmaceuticals with a second complete response letter (CRL), denying approval of its new drug application (NDA) for terlipressin for the treatment of adults with hepatorenal syndrome type 1(HRS-1) and calling for more data. Read More