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FDA on Thursday issued an update on the agency's efforts to combat the companies and individuals who are exploiting or taking advantage of widespread fear during the COVID-19 pandemic and selling unproven medical products.
FDA has approved capmatinib (Tabrecta—Novartis) for the treatment of adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).
In the past 2 days alone, Cohen Children's Medical Center in Long Island, NY, has admitted five critically ill patients—aged 4 years to 12 years—with an unusual sickness that appears to be linked to COVID-19.
Hospital and community compounding pharmacists will have more flexibility thanks to FDA guidances aimed at easing drug shortages during the COVID-19 pandemic. The agency will use discretion in enforcing certain standards around 503A and 503B compounding.
In February, Eisai removed the weight-loss drug lorcaserin (Belviq, BelviqXR) from the market at FDA’s request, which cited a safety clinical trial that found an increase in cancer incidence among people who take the medication. However, lorcaserin’s removal leaves behind multiple options for weight loss. Pharmacists should carefully review the patient’s medication list as many of these drugs may interact with other medications.
FDA on Monday announced commercial coronavirus antibody tests will have to pass agency muster, including meeting standards for quality and accuracy.
Does zinc have any effect on COVID-19 disease? In a recent episode of APhA’s 15 on COVID-19 educational series, Daniel Zlott, PharmD, BCOP, vice president of professional education resources at APhA, provided information on the possible use of zinc to treat COVID-19. The bottom line, said Zlott, is that there is currently no data, either in vitro or in vivo, to support it.
FDA on Friday issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The investigational antiviral drug was shown in a clinical trial to reduce the time to recovery in some patients.
Driven by the spread of COVID-19, research teams have been screening thousands of drugs to see if they have this unexpected potential to fight the coronavirus. They have tested the drugs on dishes of cells, and a few dozen candidates have made the first cut for repurposing.
Federal health regulators are exploring whether to approve the emergency use of the Gilead Sciences drug remdesivir in serious COVID-19 patients, after U.S. government researchers reported the therapy helped the patients recover faster.