Washington University in St. Louis

CMS didn’t wait for President-elect Donald Trump to take office before issuing its second list of drugs to be negotiated under the Inflation Reduction Act, even though the agency had until Feb. 1 to release it. CMS officials on Friday explained the decision on a media call, saying the early release ahead of the statutory deadline will provide manufacturers with more time to prepare their data for the negotiations. But once the Trump administration takes over next week, it could move in several different directions to either support or quash drug price negotiations in the future. If the Trump administration were to make changes to the negotiations, a CMS official said Friday that “it would require additional guidance and potential rulemaking and potentially new information.” The incoming administration hasn’t said anything public yet on its direction. Rachel Sachs, law professor at Washington University in St. Louis, told Endpoints News that the Trump administration may not even need to push to repeal the IRA. Instead, the administration could direct its lawyers to walk away from the dozens of court cases from biopharma companies seeking to halt the law. She noted that the Trump administration in its first term declined to defend the constitutionality of the Affordable Care Act in court, but some states later intervened and were successful at the Supreme Court. On the idea floated by Eli Lilly CEO David Ricks that the next administration could pause the IRA’s negotiations process , Sachs noted that the law doesn’t include any mention of a pause. She said the statute is written in a way that once the list of the next round of drugs up for negotiations is released, CMS and manufacturers have to meet certain statutory deadlines. Major changes from the Trump administration’s CMS, to be led by television personality Mehmet Oz, would likely come for the 2028 cycle of negotiations. Tricia Neuman, senior vice president at the nonprofit KFF, wrote the Trump administration could go in three directions with the IRA: “stay the course, water it down or repeal it all together.” Trump has previously railed against pharmaceutical prices in the US, and proposed a most-favored-nations policy to set prices based on other countries, so he may decide to not only stay the course but double down on negotiated drug prices, Neuman said. Both Neuman and Sachs said they don’t know which direction the Trump administration will ultimately take because drug pricing in general wasn’t a major point of his on the campaign trail. ATI Advisory’s Anna Kaltenboeck, former co-author of the IRA’s drug-negotiation section, said Trump’s CMS also could alter its guidance or how it interprets parts of the law, such as how many times it meets with drugmakers, or how many listening sessions it holds. “The degree to which they play hardball with manufacturers in the process could change,” she said. Guidance is coming this spring for the 2028 round of drugs, Neuman told Endpoints, noting that that will be the first glimpse at what this next administration is doing. Sachs also noted that the program changes significantly in 2028, with the addition of Medicare Part B drugs. KFF published a poll on Friday showing bipartisan support for expanding the number of drugs to be negotiated, and weaker support for a repeal. A full repeal of the IRA also “could come at a cost in the court of public opinion and could result in higher Medicare spending and higher drug costs for people with Medicare,” Neuman added.

Advisory group guidance enables nonprofit to be at the forefront of Alzheimer\'s research WELLESLEY HILLS, MA / ACCESSWIRE / January 14, 2025 / Cure Alzheimer\'s Fund announced today that six scientists specializing in Alzheimer\'s disease and related research have joined its Research Leadership Group (RLG).The expertise and active engagement of the RLG guide Cure Alzheimer\'s Fund to support research with the highest probability of preventing, slowing or reversing Alzheimer\'s disease. RLG members provide vital insights into emerging and innovative scientific ideas from labs around the world and are a main source of referrals to promising researchers and their work. Additionally, the RLG plays a crucial role in shaping the nonprofit\'s grant portfolio strategy by providing critical feedback and recommendations. Since its inception in 2004, Cure Alzheimer\'s Fund has distributed more than $219 million in grants.\"Our Research Leadership Group and their collective scientific expertise and knowledge are tremendous assets to our organization,\" said Meg Smith, CEO of Cure Alzheimer\'s Fund. \"Their counsel ensures we fund the most promising avenues of research that will advance our understanding of Alzheimer\'s disease and move us closer to effective treatments.\"Laura M. Cox, Ph.D., is an assistant professor in the Department of Neurology at the Ann Romney Center for Neurologic Diseases at Harvard Medical School and Brigham and Women\'s Hospital. Her lab is currently investigating the role of the microbiome in neurologic diseases, including Alzheimer\'s disease, Parkinson\'s disease, multiple sclerosis and amyotrophic lateral sclerosis. Dr. Cox established her lab in the fall of 2021 and is identifying age-related changes in the gut microbiota that may affect Alzheimer\'s disease by modulating peripheral and central immunity.Alison Goate, D. Phil., is the Jean C. and James W. Crystal Professor and Chair of the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai. She has worked on the genetics of neurodegenerative diseases since 1987. Over the last three decades, Dr. Goate has been part of many gene-finding teams that have successfully identified disease-causing variants for both Alzheimer\'s disease and frontotemporal dementia.Teresa Gomez-Isla, M.D., is a professor of neurology at Harvard Medical School, chief of the Memory Division in the Neurology Department at Massachusetts General Hospital, associate director and clinical core leader of the Massachusetts Alzheimer\'s Disease Research Center and director of the MGH Clinical Fellowship in Dementia Program. Her current research focuses on the study of brain changes associated with aging, especially those that occur very early on in Alzheimer\'s disease; on understanding mechanisms of brain resilience to Alzheimer\'s pathology; and on the validation of novel imaging biomarkers for early disease detection and intervention.Costantino Iadecola, M.D., is the director and chair of the Feil Family Brain & Mind Research Institute and the Anne Parrish Titzell Professor of Neurology at Weill Cornell Medical College. Considered a pioneer in establishing the concept of neurovascular unit, his research focuses on the basic mechanisms of neurovascular function and on the cellular and molecular alterations underlying ischemic brain injury, neurodegeneration and other conditions associated with cognitive impairment.Leonard Petrucelli, Ph.D., is the Ralph B. and Ruth K. Abrams Professor and Chair of the Department of Neuroscience at Mayo Clinic in Florida, and serves as vice chair for the Florida Alzheimer\'s Disease Research Grant Advisory Board, chief scientific adviser for Target ALS and on the Scientific Advisory Board for Science Translational Medicine. His laboratory has been at the forefront of research investigating the cellular mechanisms that cause neurodegeneration in diseases characterized by abnormal protein aggregation like Alzheimer\'s disease.Andrew S. Yoo, Ph.D., is a professor in the Department of Developmental Biology at Washington University School of Medicine in St. Louis. He has a longstanding interest in understanding genetic pathways that specify cell fates during development, and currently studies the role of microRNAs in regulating the activity of chromatin remodeling complexes during neural development and conversion of nonneuronal cells into neurons.Cure Alzheimer\'s Fund is a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer\'s disease. Since its founding in 2004, Cure Alzheimer\'s Fund has provided 918 grants to more than 300 of the world\'s leading researchers and contributed more than $219 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer\'s disease. Cure Alzheimer\'s Fund has achieved a 100% perfect score and a Four-Star rating for 13 consecutive years from Charity Navigator. Cure Alzheimer\'s Fund also received a Platinum Seal of Transparency from Candid, formerly known as GuideStar. Our Board of Directors, Trustees and a core group of other donors direct their donations to our overhead expenses so that 100% of general donations go to our research program. For more information, visit CureAlz.org.Contact DetailsBarbara Chambers+1 978-417-9890[email protected]Company Websitehttps://curealz.orgSOURCE: ALZHEIMER\'S DISEASE RESEARCH FOUNDATION

FRIDAY, Jan. 3, 2025 -- Vagus nerve stimulation (VNS) shows a positive treatment effect and improved quality of life (QoL) among patients with treatment-resistant depression (TRD), according to two studies published online Dec. 18 in Brain Stimulation . Charles R. Conway, M.D., from Washington University in St. Louis, and colleagues conducted a multicenter, double-blind trial involving 493 adults with treatment-resistant major depression who were randomly assigned to receive 12 months of active or no stimulation sham VNS; 88.4 percent of participants completed the trial. The researchers found that the percent time in Montgomery-Åsberg Depression Rating Scale response could not differentiate active from sham VNS. However, antidepressant benefits significantly favored active VNS based on ratings from on-site clinicians and offsite masked raters. Significantly more percent time in response on the Clinical Global Inventory-Impression and Quick Inventory of Depressive Symptomology-Self Report was seen with active VNS. A. John Rush, M.D., from Duke-NUS Medical School in Singapore, and colleagues compared the effects of active versus sham VNS on QoL and function in TRD in a multicenter, randomized study involving 493 adult patients with four or more unsuccessful antidepressant treatment trials. The researchers found that active VNS was superior to sham in terms of mean change from baseline in the seven-item subset of the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Mini-Q-LES-Q) and Work Productivity and Activity Impairment Questionnaire (WPAI) item 6 used as continuous variables; a similar trend was seen for Q-LES-Q. Based on the Mini-Q-LES-Q, WPAI item 6, and Q-LES-Q, active VNS was superior to sham in time spent in clinically meaningful benefit. "What's really important here is that patients themselves were reporting that their lives were improving," Conway said in a statement. Several authors disclosed ties to pharmaceutical and medical technology companies, including LivaNova; LivaNova funded the original study from which these findings were derived. Abstract/Full Text - Conway Abstract/Full Text - Rush Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.