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The FDA’s Center for Drug Evaluation and Research (CDER) has issued two newly updated manuals aimed at the agency’s staff, but useful for the regulated community as they allow a window into how FDA is planning to handle certain internal activities. Read More
Merck and Miami, Fla.-based Ridgeback Biotherapeutics are starting a phase 3 clinical trial of molnupiravir, which is intended to stop infection with COVID-19 after a person has been exposed. Read More
Pfizer began dosing yesterday in a phase 2/3 study evaluating its oral COVID-19 antiviral PF-07321332 in non-hospitalized symptomatic patients who are not at increased risk of progressing to severe disease. Read More
A New York bankruptcy judge has provisionally approved OxyContin maker Purdue Pharma’s controversial reorganization settlement, affording the family who owns the company immunity from future opioid-related litigation, a protection usually reserved for companies, not individuals. Read More
The FDA has updated its guidance on conducting clinical trials during the COVID-19 pandemic, advising sponsors to use a risk assessment to see if they need to re-monitor remotely monitored data using in-person site visits after pandemic restrictions are lifted. Read More
A county judge in Ohio has issued a court order forcing a Cincinnati hospital to give the anti-parasitic ivermectin for three weeks to a man suffering with COVID-19. Read More
Overdoses of ivermectin are linked with low blood pressure, decreased consciousness, confusion, hallucinations, seizures, coma and even death. Read More
In a separate contamination incident, Japan last week halted the use of 1.63 million Moderna doses distributed to vaccination centers due to possible contamination. Read More
Pfizer said Monday that its atopic dermatitis treatment abrocitinib had demonstrated efficacy in a late-stage clinical trial that compared the treatment with Sanofi and Regeneron’s Dupixent (dupilumab). Read More
The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have come together to try to conquer the problem of big data. Read More
The FDA has reissued its emergency use authorization (EUA) for Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab for treatment of COVID-19 — but only for certain states. Read More