Visx/Alcon Laboratories
This article was originally published in The Gray Sheet
Executive Summary
Firms sign letter of intent under which Visx "for a negotiated fee" will make use of Alcon's "resources and expertise" to guide a voluntary review of Visx clinical investigative sites. FDA recently sent Form 483 inspectional observation reports to two of Visx's 26 investigative sites ("The Gray Sheet" Sept. 12, p. 13). However, Visx maintains that its decision to conduct the independent reviews "was neither requested nor required by the FDA." The agreement also calls for Alcon to provide further "regulatory services" to Visx "on an ongoing basis." In addition, Visx announces that Alcon Chairman, CEO and President Edgar Schollmaier will rejoin Visx' board of directors; Schollmaier served on the Visx board from 1987 to 1993
You may also be interested in...
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.
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.