Alzheimer's Patent Battle May be Brewing
Executive Summary
Nova Molecular’s plans to run an Alzheimer’s diagnostic service could infringe on an exclusive worldwide licensed granted to Athena Neuroscience.
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Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.