While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
South Korea’s Gwangju Institute of Science and Technology (GIST) has completed a preclinical study for a noninvasive therapy for Alzheimer’s disease. The "ultrasound-based gamma entrainment” technique involves syncing up gamma waves, or brain waves above 30 Hz, with an external oscillation of a given frequency. This happens naturally by exposing a subject to a repetitive stimulus, such as sound, light, or mechanical vibrations.
A novel dual-action small molecule developed by a team led by scientists at Kyungpook National University (KNU) in Daegu, South Korea, has been shown to improve the neuropathological features of Alzheimer's disease (AD) in mice, the authors reported in the Jan. 18, 2022, edition of ProceedingsoftheNationalAcademyofSciences.
Investigators have identified structural differences between amyloid-beta (Abeta) aggregates in the postmortem brains of patients with inherited and sporadic Alzheimer's disease (AD), respectively. Moreover, both were different from the aggregates that form when Abeta assembles in vitro.
The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond.
In proposing a national coverage determination to limit coverage of a class of Alzheimer’s drugs to those being used in clinical trials approved by the U.S. Center for Medicare & Medicaid Services or the NIH, CMS appears to be treading in FDA territory. “For the first time ever, Medicare is second-guessing FDA – and not only on work that it has already done, but on work FDA will do in the future,” said George Vradenburg, chair and co-founder of Us Against Alzheimer’s, a patient advocacy group. “HHS [the Department of Health and Human Services] is clearly at war with itself, with one agency approving this class of drugs and another slamming the door shut on treatment. . .. Does CMS no longer trust the FDA’s work?”
“There isn’t a better place to be” now than in Alzheimer’s disease (AD) drug development, said Phyllis Ferrell, global head of external engagement in AD and neurodegeneration at Eli Lilly and Co., during Biotech Showcase’s panel talk titled, “Aduhelm: Stimulating the Next Generation of AD Treatment.”
This could be a make-or-break week for Biogen Inc., with the U.S. Centers for Medicare & Medicaid Services (CMS) expected to announce a draft coverage decision for the company’s Alzheimer’s drug, Aduhelm.
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
There are many companies using artificial intelligence to aid drug development, with a seemingly overwhelming number of “world firsts” being claimed in this quickly evolving field. After signing a three-year neurology drug development deal with Eli Lilly and Co. worth up to $706 million in July, Verge Genomics is also making waves and just raised $98 million in series B financing to support development of its own AI drug development technology.
