Pharmaceutical Technology Editors

More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner.

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more...

The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week.

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

An outstanding new book reviews alternative solvents with an eye to sustainable pharmaceutical processes.

A second-generation and green manufacturing process for testosterone provided economic and ecological benefits.

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.

On Aug. 19, 2009, the US Food and Drug Administration opened a new Center for Tobacco Products on the agency's White Oak Campus in Silver Spring, Maryland.

Scientists have modified a tobacco plant to produce a vaccine for norovirus, the viral infection sometimes called the "cruise ship virus."

Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...

Also, USP signed a Memorandum of Understanding with the Permanent Commission of the Pharmacopeia of the United Mexican States, more...

Researchers at the University of Illinois (Champaign) have developed a cancer drug delivery system that reportedly kills target tumor cells, spars healthy cells, and has effects that can be reversed to halt potentially hazardous side effects.

Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...

India accounts for approximately 3% of the global outsourcing market, which indicates a significant opportunity for growth, according to a report published by Ernst and Young and the Organization of Pharmaceutical Producers of India.

Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more...

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2009 edition from AEC and Sensor Products.

Cooling water is a critical component in the research and development, bulk manufacturing, and packaging of pharmaceuticals.

Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...

On August 6, the Biotechnology Industry Organization (BIO) filed an amicus brief asking the US Supreme Court to overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit.

The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.

Also, EMEA gives public access to GMP data; SOCMA speaks out on toxic substances; more...

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

The Energy and Commerce Committee of the US House of Representatives approved H.R. 3200, America's Affordable Health Choices Act, last Friday.

The US Food and Drug Administration and European Medicines Agency (EMEA) launched this week a joint initiative to collaborate on international good clinical practice (GCP) inspection activities.

The author of an ambitious book about quality control falls short of reaching his goals.

The author of a book about biopharmaceutical production includes irrelevant information.