US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization
To help reduce medication errors that can harm patients and compromise research results, FDA – pushed by clinical trial sites – looks to exert more control of the labels of investigational drug products.
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PBM Reform: Vertical Integration, Specialty Drug Tracking Among Differences In House v. Senate Bills
House Energy and Commerce Committee cleared a PBM bill that seems to contain more transparency loopholes and makes more limited policy tweaks to the drug supply chain middleman than the Senate HELP Committee’s bill, but the House-side legislation would pull back the curtain on specialty-drug reimbursement in a way the Senate version does not.
GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals
From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.
The US VA And Alzheimer’s: A Misunderstood Decision
US Department of Veterans Affairs' head for pharmacy benefits management says her agency’s coverage of Leqembi and Aduhelm is actually closely aligned with that provided by Medicare, in contrast to the initial characterization of the VA taking a different stance on the drugs.