Biorchestra Co. Ltd. has raised ￦54 billion ($45.1 million) in its latest series C fundraising, which will boost the development of the company’s lead RNA-based candidate for treating neurodegenerative diseases. BMD-001 is Daejeon, South Korea-based Biorchestra’s antisense oligonucleotide candidate for treating Alzheimer’s disease.
With an ambitious goal of bringing 24/7 electroencephalogram (EEG) capabilities to hospitals across the country, Epitel Inc. closed a $12.5 million series A financing round that it plans to use to fund the initial pilot for commercialization of its wearable, wireless EEG platform. The Epilog platform received FDA clearance for use in hospital emergency departments and critical care units last year.
As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.
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.”
