Despite expectations that Bristol-Myers Squibb/Pfizer’s novel oral anticoagulant apixaban would sail through FDA on the strength of the superior efficacy and safety compared to warfarin in the ARISTOTLE trial, study conduct issues led to a nine-month delay in approval.
Concerns surrounding the conduct of the ARISTOTLE pivotal trial twice led FDA to delay approval of Bristol-Myers Squibb Co./Pfizer Inc.’s antithrombin Eliquis (apixaban).
The oral anticoagulant’s approval was delayed by nine months, from its original PDUFA date of March 28, 2012 to its...
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.
The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.
The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.
The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.
