Immuno-Innovation

Latest from Immuno-Innovation

Immunotherapy treatments such as antibodies targeting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) and PD-1 ligand1 (PD-L1) have shown promise in reactivating weakened immune cells to fight cancer. While these immunotherapies have had a dramatic impact in some cancer patients, the positive results only appear in a fraction of cases. The cost of treatment and potential for immune-related adverse events make it imperative that doctors have protocols to identify patient…
Welcome to Immuno-Innovation, Mayer Brown’s blog reporting at the intersection of Immunotherapy and Intellectual Property law with legal analysis, updates on case law and legislative developments, as well as trend-spotting and best practices. Over the last twenty-five years, immunotherapy has been a fast-moving field (even if its newsworthy advances have appeared to proceed in increments), and the innovations that drive it are an abundant source of potentially valuable intellectual property rights. The goal of Immuno-Innovation…
March 23, 2020 marked the tenth anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which provided the approval pathway for biosimilar products. While it was five years before the first biosimilar—Sandoz’s Zarxio—was introduced in the United States, we now have twenty-six approvals and seventeen biosimilars on the market. With the steep increase in biologic drugs, presently accounting for 50% of sales within the pharmaceutical market, the pace of biosimilar development…
Antibody-based serology tests and PCR tests for coronavirus are being approved at a breakneck pace by the U.S. Food and Drug Administration under newly relaxed guidelines. As recently as May 8th, the FDA issued an emergency approval for another serology test for coronavirus antibodies, an immunofluorescent sandwich assay necessarily developed in under six months. https://www.fda.gov/media/137886/download. Scientists also just reported the identification of neutralizing antibodies that are unique to SARS-CoV-2, which may trigger a flood…