Pharmaceutical Technology Editors

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.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

Abbott Agrees to Acquire Facet Biotech; FDA Issues Black-Box Warning For Plavix; and More.

FDA Issues Warning Letter To Paddock Laboratories; And More.

Three companies joined the University of Pittsburgh Medical Center's 21st Century Biodefense initiative to establish a flexible vaccine development and production facility.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the March 2010 edition from Munters and NETZSCH.

Recent developments demonstrate the importance of biologicals, which usually are delivered through injections, for the drug industry's future. To find out about the process of manufacturing prefilled syringes, and to learn about innovations in filling lines, Equipment and Processing Report talked to Thomas Otto, managing director of Vetter.

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.

Last week, the US Food and Drug Administration and the National Institutes of Health unveiled plans to establish a Joint Leadership Council to address important public-health issues.