Ionis Antisense Platform Safety Questioned After Thrombocytopenia Seen In Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
GSK halts plans for Phase III study of antisense candidate in FAC due to FDA clinical hold for findings of reduced platelet counts in another Phase III trial; Ionis reveals similar findings in Phase III study of another antisense compound.
You may also be interested in...
GSK Bolsters Orphan Drug Discovery By Signing Antisense Deal With Isis
Under the deal, which has all the hallmarks of a GSK option-based alliance, Isis gets $35 million upfront, and will deliver five drugs through PoC.
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.