CV Outcomes and Anoro: An Excerpt From The Summary Review
This article was originally published in RPM Report
Executive Summary
Here is Office of Drug Evaluation II Director Curtis Rosebraugh’s discussion of the decision not to require a cardiovascular outcomes trial for GlaxoSmithKline/Theravance’s Anoro Ellipta (umeclidinium/vilanterol or UMEC/VI) combination inhaler for COPD. The memo is date December 18 and was discussed during the Feb. 12 FDA/IoM workshop on “uncertainty” in risk/benefit analyses.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.