The question of prices for a COVID-19 vaccine have raged in recent days. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), told members of a Senate committee that vaccines developed with the help of taxpayer funding will come with an appropriate reduction in price. However, CDC Director Robert Redfield emphasized that the cold-chain distribution system for those products requires the same kind of at-risk investment that is used for vaccine development.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
Keeping you up to date on recent developments in oncology, including: New microfluidic platform enables deeper analysis of role of angiogenesis in cancer; P53 'glue' gums up cancer cells; New blood test could aid in hepatocellular carcinoma screening.
Ethicon U.S. LLC has prevailed in a preliminary action seeking a temporary restraining order against Advanced Inventory Management (AIM) Inc., of Mokena, Ill., which is accused of having imported and sold surgical supplies falsely bearing the Ethicon trademark. Ethicon, a subsidiary of Johnson & Johnson of New Brunswick, N.J., further alleges the sutures were bacterially contaminated and defective.
Conventional wisdom has it that recent expansions in coverage of telehealth will never be fully reversed. The addition of artificial intelligence (AI) into telehealth could solve several issues faced by doctors and hospitals. There is some concern, however, that the blending of AI and telehealth will industrialize the practice of medicine, dissuading patients from seeking critically needed care.
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
The Supreme Court has declined to hear three cases that questioned the inter partes review (IPR) process for patent litigation, although the petition for cert for the Arthrex Inc. v. Smith & Nephew Inc.; Arthrocare Corp.; and the United States of America case is still pending. Should the Supreme Court pass on Arthrex, the remaining affected IPR cases will have to be relitigated at the Patent Trial and Appeal Board (PTAB), which may give those patent holders another chance to restore their patents.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
Keeping you up to date on recent developments in oncology, including: Focused ultrasound may help thwart glioblastoma; Manipulating the macrophage for cancer therapy; FDA’s oncology center initiates patient voice program; FDA’s oncology center initiates patient voice program; Sedentary behavior predictive of cancer mortality.