Pharmaceutical Technology Editors

FDA Clears Infant Rotavirus Vaccine

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Sundlof Resigns as FDA's Head of Food Safety; and More

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

FDA Issues Warning Letter To Pfizer; And More.

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2010 edition from Camfil Farr and K-Tron.

The green movement promises to make life-sciences manufacturing processes more environmentally friendly.

If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.

FDA Issues Warning Letters to Six US Medical Spas; and More.

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.

The US Food and Drug Administration held a public meeting in Rockville, Maryland, on April 12, 2010, to solicit stakeholders' comments about the Prescription Drug User Fee Act program.

FDA Approves New Formulation For OxyContin To Discourage Misuse And Abuse.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.

FDA issued a final rule to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents.

FDA Issues Safety Warning Regarding Zocor; And More.

Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.