PERTH, Australia – Australia has recently established new research and discovery centers to study psychedelic treatments for mental health disorders. Headquartered Melbourne, the Psychae Institute is a global research collaboration supported by a AU$40 million (US$29 million) investment from a North American biotechnology company.
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?”
Targeting the toxic alpha-synuclein protein found in the brains of people with Parkinson’s is one of the most promising approaches to treat the disease in the clinic – but getting any drug into the brain is a challenge. Sanofi SA has joined with ABL Bio Inc. to solve this problem, in-licensing ABL-301, a preclinical bispecific antibody that locks on to misfolded alpha-synuclein but also includes a molecular “shuttle” that allows it to penetrate the blood-brain barrier.
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