The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.
Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
α7 nicotinic acetylcholine receptors (α7nAChRs), expressed in neurons and astrocytes at lower levels, have been implicated in neuroinflammatory and neurodegenerative processes associated with Alzheimer’s disease (AD). Evidence suggests that α7nAChRs interact with soluble amyloid-β (Aβ), contributing to reactive astrogliosis and formation of Aβ plaques in AD.
Researchers from Aarhus University and Synuca Therapeutics recently presented a novel drug-like small-molecule inhibitor of sarco/endoplasmic reticulum calcium ATPase (SERCA), SYN-4569, with superior pharmacological properties and evaluated its efficacy in vitro and in vivo. SYN-4569 is an orally available compound with good potency, pharmacokinetics and brain-penetrant properties.
Watchers of the percolating myasthenia gravis space are waiting eagerly for data from Dianthus Therapeutics Inc.’s phase II Magic study testing DNTH-103, an active C1s inhibitor, compared to placebo in patients with anti-AChR-positive generalized disease.
At the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (ADPD), researchers from Rutgers University investigated the therapeutic potential of CJRB-302, a live biotherapeutic product derived from healthy human gut microbiota, to improve PD motor symptoms and pathology.
At the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (ADPD), researchers from Beijing Joekai Biotechnology LLC presented the discovery process and preclinical results for 50561.