On October 1, 2021, the World Health Organization issued a report on the 22nd Model Essential Medicines List (EML). The new list added four new drugs for cancer, including enzalutamide, but also illustrated the role of high prices as a barrier to access. The WHO noted in a press release that: “A group of antibodies that enhance the immune response to tumour cells, called PD-1 / PD-L1 immune-checkpoint inhibitors, were not recommended for listing for the treatment of a number of lung cancers, despite being effective, mainly because of their exceedingly high price and concerns that they are difficult to manage in low-resourced health systems.Read More →

On Friday July 9, 2021, the Union for Affordable Cancer Treatment (UACT) and Knowledge Ecology International (KEI) filed joint comments with the National Institutes of Health (NIH) regarding a prospective exclusive license for a cancer therapy technology. The Federal Register notice titled, “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies” (86 FR 33326), outlined that the technology is to be licensed to Syncopation Life Sciences Inc. (Syncopation), which is based in Palo Alto, CA. The technology is an anti-CD22 CAR therapy, which has been shown to be effective inRead More →

The National Institute of Standards and Technology (NIST), a part of the US Department of Commerce, proposed a slate of detrimental changes to regulations in the Bayh-Dole Act governing “Rights to Federally Funded Inventions and Licensing of Government Owned Invention.” The public was given the opportunity to comment on the proposed changes, and by the close of the comment period on April 5, 2021 NIST had received over 81,000 comments on the issue. The proposed changes cover a variety of areas that impact policies concerning access to medicines and drug pricing, including patients’ rights to challenge the government’s grant of a taxpayer-funded invention to aRead More →