The Centers for Medicare and Medicaid Services (CMS), in a final national policy decision, is allowing Medicare to cover the cost of Aduhelm (aducanumab) and other medicines in its class given accelerated approval only for Alzheimer’s disease patients enrolled in qualifying clinical trials. Should Adulhelm or future amyloid-targeting monoclonal antibodies be given standard or full — rather than…
Conditions
Conditions
Myeloma Action Month Reaches More Than 30M Worldwide, Foundation Says
More than 30 million people in 46 countries joined together to participate in Myeloma Action Month (MAM), a campaign in March to raise awareness of the rare blood cancer. The International Myeloma Foundation (IMF), which organized the month-long campaign, says the awareness efforts were a success and helped to inspire “a culture of hope and…
NNI-362 Is Safe, Lowers Alzheimer’s Biomarker in Older, Healthy Adults
NNI-362, Neuronascent’s investigational treatment for Alzheimer’s disease, was safe and reduced blood levels of an Alzheimer’s biomarker in a Phase 1a trial of the therapy in healthy, older adults. The primary goal of the trial (NCT04074837), which enrolled 56 adults between the ages of 50 and 72, was to determine the safety and tolerability of…
Eisai, Geisinger to Test If AI Tool Can Identify Early Dementia Risk
Eisai has partnered with Geisinger to assess whether a machine-learning model can accurately identify people with cognitive impairment — which may suggest early signs of dementia. Machine learning is a form of artificial intelligence (AI) that uses algorithms to analyze data, learn from its analyses, and then make a prediction. The AI tool will be…
Telehealth Added to Latest Digital-friendly NORD State Report Card
The National Organization for Rare Disorders (NORD) has updated its State Report Card to make it more digitally friendly and added telehealth to its categories of rare disease policy issues in a nod to its increased use during the ongoing COVID-19 pandemic. NORD’s report card project began seven years ago with the goal of evaluating…
STAR Molecule Shows Promise in Cell Model of Alzheimer’s Disease
Gain Therapeutics‘ investigational STAR (small-molecule structurally targeted allosteric regulators) candidate lowered toxic amyloid-beta and tau protein levels, both hallmarks of Alzheimer’s disease, in a cellular model of the disease. Treatment with the STAR molecule enhanced the survival and boosted communication between nerve cells, the company announced. The results support the potential of STARs molecules for…
Researchers Identify Potential Antibody-based Myeloma Therapy
Researchers in Japan have identified an antibody that binds to a myeloma-specific form of a common cell surface protein, called CD98 heavy chain, and that prolongs survival when given to a mouse model of multiple myeloma. The findings were detailed in the study, “Selective targeting of multiple myeloma cells with a monoclonal antibody recognizing the…
CogniCann, Potential Cannabinoid Therapy, Being Prepared for Europe
Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs. The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in…
Clinical Trials Show Promise For Araclon’s Vaccine, Diagnostic Test
ABvac40, an investigational vaccine, was safe and led to antibodies forming against the toxic amyloid-beta 40 peptide in people with Alzheimer’s disease, according to data from a Phase 2 trial. ABvac40’s developer, Araclon Biotech, has also made progress in developing a blood test to detect Alzheimer’s in its early stages, Araclon’s lead shareholder, Grifols, reported…
Dosing Begins in Phase 2 Trial of XPro1595, Targeting Inflammation
A first patient has been dosed in a Phase 2 trial of XPro1595, INmune Bio’s candidate therapy for Alzheimer’s disease. The MINDFuL trial (NCT05318976) aims to recruit around 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites in the U.S., Australia, and Canada. Top-line results are expected in 2023. For…
Europe Awaits Proposed New Framework for Sharing Health Data
The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to help encourage evidence-based healthcare, spur…
Biogen Withdraws Application Seeking Approval of Aduhelm in EU
Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products for Human Use (CHMP), but now the…