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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
During a virtual hearing, opioid maker Purdue Pharma told New York bankruptcy judge Robert Drain that the Sackler family, Purdue’s owners, are no longer seeking releases for non-opioid liability as part of their settlement, but are still seeking liability immunity related to opioid claims. Read More
AstraZeneca (AZ) said that its once-daily oral investigational drug, ALXN1840, performed well in phase 3 clinical trial for patients with Wilson disease, a rare, genetic condition, removing excess copper from tissues approximately three times more effectively than standard of care treatments. Read More
The number of new drugs expected to come into the marketplace will drop by 60 over the next 30 years due to effects of the Medicare drug price negotiations bill H.R. 3, the Congressional Budget Office (CBO) said in a new report. Read More