Pharmaceutical Technology Editors

To establish user fees for the 2009 fiscal year, the US Food and Drug Administration is asking pharmaceutical manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16, 2008.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.

Brief pharmaceutical news items for May 2008.

Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

MannKind suspended discussions with potential partners for the commercialization of its "Technosphere Insulin" product.

This issue of Equipment & Processing Report features products from Leistritz and Millrock Technology

Dave Drew, group pharmaceutical director of Matcon (Moreton-in-Marsh, UK), says that lean production is essential for drugmakers to survive in the current environment.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, Jubilant Organosys to acquire DRAXIS Health, PPD's Paul Covington to retire, more...

Combining atomic force microscopy and infrared spectroscopy, scientists at the University of Illinois have demonstrated a method for simultaneous structural and chemical characterization of samples at the femtogram (10-15g) level.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.

One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

In a press release, the University of Texas announced that Mauro Ferrari, of the University?s Health Science Center at Houston, presented a proof-of-concept study of a new multistage delivery system for imaging and therapeutic applications.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

Scientists at the University of North Carolina at Chapel Hill have successfully tested a new inhaled tuberculosis (TB) vaccine.

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

The US Senate passed an amendment to the fiscal year 2009 budget bill that will increase the amount allotted to FDA by $71 million, bringing the agency's total FY 2009 budget increase to $375 million.

Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website.

This issue of Equipment & Processing Report features products from Eriez Magnetics and Netzsch Fine Particle Technology