Year-end "Focus on": News and updates on the novel pharmacologic agents reviewed over the past 12 months; Focus on prasugrel; Pharmaceutical pipeline database products
Oxycodone on Packaging Line Leads to Recall of Betaxolol
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
Manufacturing Issues Lead to CRL for Liquid Botulinum Toxin
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.
Medicare Drug Price Negotiations to Move Forward
ICER has weighed in on two of the 10 drugs selected for negotiations: Eliquis and Xarelto, which are among Medicare Part D’s highest spending drugs.
IRA Impact: Lowered Patient Costs, but Also Higher Utilization Management?
Once Medicare’s negotiated price for prescription drugs goes into effect, payers have more of an incentive to steer patients to lower-cost alternatives.
Oncology Drug Exkivity to be Withdrawn from U.S. Market
In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
FDA Assigns Review Date for Gene Therapy for Rare Immune Disorder
FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.
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