News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Advanced Medical Solutions buys Resorba. Roche picks up Verum Diagnostica. Invacare enters discussions for consent decree.
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Invacare Compliance Challenges, Product Delays Impact Q3 Results
Talks with FDA are ongoing about compliance with quality system regulations and a proposed consent decree that would shut down certain operations at a wheelchair manufacturing plant in Elyria, Ohio, executives said during the firm’s Oct. 25 earnings call.
Regulatory News In Brief
Fiscal 2012 budget cuts: White House Office of Management and Budget Director Peter Orszag and White House Chief of Staff Rahm Emanuel are directing federal agencies to find ways to cut their fiscal 2012 budgets by 5%, according to a June 8 1memo and budget 2guidance. Agencies should identify programs "that have the lowest impact on your agency's mission," the memo states. Fiscal 2012 budget submissions are due to OMB by Sept. 13. The Obama administration has pledged to freeze non-security discretionary spending through fiscal 2013
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.