Analytics

Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...

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

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.

Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Brief pharmaceutical news items for May 2008.

Recent advances in SEM, particularly the incorporation of automation and software, have made simpler, lower-end SEM instruments easy to operate and have improved the capabilities of larger, sophisticated instruments.

The current trend within the pharmaceutical industry toward more efficient development, manufacturing, and specification is fueling demand for analytical tools that provide highly relevant information. Effective powder characterization has a valuable role to play.

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

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...

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

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.

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

A changing regulatory environment is on the horizon for excipient suppliers and users.

The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.

The FDA itself issues a cry for help. Is anybody listening?

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

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

The US Pharmacopeial Convention announced a revised glycerin monograph in the United States Pharmacopeia.

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