Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.
Geneventiv Therapeutics Inc. has been awarded a Direct to Phase II Small Business Innovation Research (SBIR) grant for approximately $2.5 million from the National Heart Lung Blood Institute (NHLBI) at the National Institutes of Health (NIH) to support development of a universal gene therapy for hemophilia A or B with or without inhibitors.
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.