Pharmaceutical Technology Editors

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2011 edition from BETE Fog Nozzle and Continental Disc.

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.

Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

The International Federation of Pharmaceutical Manufacturers and Associations issues a Framework for Action for noncommunicable diseases.

The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain.

Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.

FDA Publishes Final Guidance on Dissolution Testing.

Roche Establishes R&D Institute in France; Sanofi Appoints Peter Guenter as Senior Vice-President, Europe; and More.

President Obama unveiled an Advanced Manufacturing Partnership designed to reinvigorate the country's manufacturing sector.

The European Medicines Agency (EMA) has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation's execution.

FDA Issues Warning Letter to Dr. Reddy's Following Inspection of the Company's Mexico-Based API Manufacturing Plant.

The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study.

Array BioPharma Restructures to Focus on Development of Clinical Programs; AstraZenica Plans Russian Expansion; and More.

Biogen Idec Receives Approval for the Avonex Pen; Xceleron Makes Several Senior Appointments; and More.

FDA Issues Consent Decree of Condemnation, Forfeiture, and Permanent injunction Against H&P Industries, the Triad Group, and Three Individuals.

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release.

The author describes the benefits and challenges inherent to cleaning in place (CIP). The article also describes the development and validation of a CIP cycle.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2011 edition from Meissner and Telstar.

Our company is getting low and unpredictable cycle life out of our diaphragm valves. This problem has caused us to implement standard operating procedures for frequent replacement of the diaphragms, which is costly and time consuming. What could be happening, and what are our options?

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company's Philadelphia Business Center.

Aveo Forms Drug-Development Pact with Centocor Ortho Biotech; Generic Pharmaceutical Association Appoints Jim Fenton as Senior Vice-President of Government Affairs; and More.

FDA Issues Final Guidance to Amend IND Reporting Requirements.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

An independent report released by the European Medicines Agency highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines.

FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.

Valeant agrees to acquire Sanitas Group; Geron makes several senior appointments; and More.

The greatest challenge faced by the EMA is the continuing expansion of the EU.

FDA held a joint meeting of its Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee to discuss whether new dosing information for oral over-the-counter drug products containing acetaminophen should be added to the label for children under age 2.