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Top news of the day from across the health care landscape.
The FDA will decide on whether to approve a new form of opioid, a 30-microgram pill of sufentanil, for use in hospitals and emergency rooms by November 3, the Washington Post reported. According to the article, the agency recommended approval of the drug, which would be marketed as Dsuvia (AcelRx), in a 10-to-3 vote on October 12. However, the chairman of the committee has publicly urged the FDA to reject the drug application in light of the ongoing opioid epidemic in the United States, the article reported.
President Donald Trump has announced a new plan to lower drug prices, in which Medicare payment for Part B drugs would be based on international prices, the Associated Press reported. According to the article, the president said in the announcement that the plan would stop unfair practices that force Americans to pay more than those in other countries for the same medications. The proposal would only apply to drugs administered in a physician’s office and would be applied as an experiment to half of the country in regions selected to take part, the article reported.
The FDA has declined to approve a pre-filled syringe version of Regeneron’s eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes, Reuters reported. According to the article, the agency asked for the completion of a small study, involving approximately 30 patients, to demonstrate physicians are able to administer the product. Eylea met the main goal in a late-stage trial to treat patients with moderate-to-severe and severe diabetic retinopathy, the article reported.
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa