Pharmaceutical Technology Editors

Pfizer, Stevens Institute of Technology, Sanofi-Aventis...

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit Training Program (RSVP). The program, initiated in 2005, aims to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities and allow CBER staff to directly observe routine manufacturing practices. The objective is to give its staff a better understanding of the biologics industry, including its challenges and operations, and improve communication with CBER staff and industry.

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.

The Chemical Heritage Foundation and the Biotechnology Industry Organization presented the 8th Annual Biotechnology Heritage Award to Alejandro Zaffaroni, PhD, a biotechnology pioneer and entrepreneur. The award was presented on April 10 at BIO 2006 in Chicago.

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Company Notes for Apr. 6, 2006

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

New Biodegradable Polyketals Developed for Drug Delivery

Progress Continues in Vaccine and Antiviral Development

First GenerationNext Awards at Interphex 2006

Spotlight on Products from Interphex

Implementing a PAT Strategy

RFID and the Future of Pharmaceutical Supply Chains

Gottlieb Challenges Manufacturers to Make Processes More Efficient

Interphex FasterCures Keynote Speaker Stresses Communication and Collaboration

Development Begins on Mutated H5N1 Virus Vaccine

Proposed Legislation to Help Fight Counterfeit Drugs

Flu vaccines. Dow veterinary vaccine made in plants. $1.95 billion FDA budget focuses on high-profile programs. Non-injectable insulins win approval. FDA releases guides to dissolution testing, quality overall summary, and new drug-label formats.

A modified modular high-pressure system can form nanosuspensions of model compounds by individually controlling cavitation, impact, and shear forces.

Letter to the Editor: Glen Jon Smith

Transdermal matrix-type patches of Nefopam hydrochloride with a combination of pressure-sensitive adhesives were developed. The polymeric composition provided a controlled and sustained release of the drug from the patches and demonstrated favorable physicochemical characteristics.

FDA Recommends Changes for 2006-2007 Flu Vaccine

Drug Sales Up 5.4%...But Growth Rate Slowing

Warning Letter: Southern Meds

Baxter Wins Contract to Develop Cell-Based H5N1 Vaccine

GPhA Seeks Additional ODG Funding, Not User Fees

Industrial Info Resources reports that North American pharmaceutical and biotechnology companies and life science research institutions are planning a $14.7-billion building boom, with more than 320 active capital projects.

Cambrex (East Rutherford, NJ) to produce Geron (Menlo Park, CA) telomerase anti-cancer vaccine. Generex (Toronto, ON.) files IND for synthetic vaccine to stimulate cell-mediated immunity to avian influenza. Dow Agrosciences (Indianapolis, IN) wins USDA approval for veterinary vaccine, the first manufactured via plant cell culture. G-8 nations pledge billons for vaccine production.

The Pharmaceutical Industry has been slow in adopting radio frequency technology (RFID) to help control diversion and counterfeiting, according to a recent study by ABI Research (Oyster Bay, NY, www.abiresearch.com). In fact, only 10 drug products are expected to be shipped with RFID tags or smart chips embedded in the labeling in the coming year.