Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
The release by the U.S. CMS of the final national coverage determination (NCD) for Biogen Inc.’s Alzheimer disease (AD) drug, Aduhelm (aducanumab), lit speculation on the meaning for others in the space. CMS is “still being conservative,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “We’re in a new era. It’s unprecedented that Medicare doesn’t pay for a drug that received approval from the FDA,” even though it was not a full but an accelerated clearance.
Neuro-Bio Ltd. has published animal data it says confirms its hypothesis about an underlying cause of Alzheimer's and showing its lead molecule NBP-14 decreases levels of brain amyloid and restores memory in a mouse model of the disease.
Carthera SA reported results from a pilot clinical trial to evaluate the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease (AD). The results, published in Alzheimer’s Research and Therapy, show early promise of the treatment in reducing the amyloid load of AD and potentially other neurological conditions as well as to stimulate neurogenesis and improve cognitive performance.
A new study from researchers at Aevisbio Inc. and the National Institutes of Health on the effect of 3,6’-dithiopomalidomide on neuroinflammation adds new detail to what might one day become a significant new therapeutic strategy to treat Alzheimer's disease and other neurological disorders.
The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.
A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.
A new study from researchers at Aevisbio Inc. and the National Institutes of Health on the effect of 3,6’-dithiopomalidomide on neuroinflammation adds new detail to what might one day become a significant new therapeutic strategy to treat Alzheimer's disease and other neurological disorders.
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.
Abbvie Inc. has paid $130 million up front to acquire Syndesi Therapeutics SA, a company working on a new mechanism to mitigate synaptic dysfunction associated with cognitive deficits. The deal includes up to $870 million in milestone payments for Syndesi's first-in-class modulators of the synaptic vesicle protein 2A, which Abbvie said could have applications across a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder.
