Patricia Van Arnum was executive editor of Pharmaceutical Technology.
AstraZeneca Agrees to $1.1-Billion Settlement to US and UK Tax Authorities
March 31st 2011AstraZeneca has been informed that the UK and US governments? tax authorities have agreed to the terms of an advance-pricing agreement regarding transfer-pricing arrangements for AstraZeneca?s US business for the 13-year period from 2002 to the end of 2014.
SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
March 17th 2011The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.
AstraZeneca Discontinues Pulmicort Production
March 10th 2011AstraZeneca announced this week that it will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product.
SOCMA Urges Congressional Action on Chemical-Site Security Standards
February 24th 2011The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US House Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, called for Congressional action to pass a three-to-five year authorization of current Chemical Facility Anti-Terrorism Standards (CFATS), which are scheduled to expire Mar. 4, 2011.
GlaxoSmithKline Responds to 60 Minutes Segment on Manufacturing Issues
January 6th 2011GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico.
DCAT President Discusses the Pharmaceutical Supply Chain
January 5th 2011Pharmaceutical Technology discusses the key issues and trends facing the pharmaceutical supply chain with Bob Kanuga, executive director of the external manufacturing organization with Merck & Co. Inc. and president of the Drug, Chemical and Associated Technologies Association (DCAT).