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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
The FDA referred manufacturers to the International Council for Harmonisation’s guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. Read More
The domination of the U.S. active pharmaceutical ingredient (API) supply chain by manufacturers based in China, India and other countries cannot be addressed without the federal government’s long-term intervention, an analysis from the Olin Business School at Washington University in St. Louis concludes. Read More
At least seven U.S. states have rejected a proposed $26 billion settlement with the three largest drug distributors and drugmaker Johnson & Johnson (J&J), possibly putting the proposal in jeopardy as the refusals could cause the companies to leave the negotiating table. Read More
A federal judge pushed back his expected ruling today on Purdue Pharma’s request to approve its controversial opioid settlement in the company’s bankruptcy case, pressing those who stand against the plan to swiftly settle with the company’s owners, the Sackler family, to avoid spending money on appeals efforts later. Read More