Pharmaceutical Technology Editors

Rockville, MD (Jan. 12)-To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use. Though cattle products are used in 75% of pharmaceutical processes and 90% of biotechnology processes, the Agency says that no approved or investigational drug appears to contain bovine material that would be prohibited under the rule.

Brussels, Belgium (Jan. 11)-EPCglobal, the not-for-profit organization dedicated to driving global adoption of the Electronic Product Code (EPC), has ratified the electronic pedigree document specification.

Akorn, Alkermes, Eli Lilly, Cambrex, more

Washington, DC (Dec. 28)-The US Department of Homeland Security (DHS) has proposed regulations for improving security at high-risk chemical facilities, a category that may include some pharmaceutical production facilities.

ARmark, Chattem, Johnson & Johnson, more.

Defects in Herceptin vials stem from a fault in the packaging process.

Dec. 28, 2006 Company Notes: Albemarle, Clinical Data, Crucell, Merck, PDA, QLT, Sanofi Pasteur, Shimadzu

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

Symposium held at 2006 AAPS Annual Meeting in San Antonio

Altus, GSK, Novasep, More

US District Court for the Eastern District of New York Magistrate Judge A. Kathleen Tomlinson's Nov. 30 2006 "Report and Recommendation" supporting a preliminary injuction requested by the plaintiffs in RxUSA Wholesale, et al v. FDA.

US District Court for the Eastern District of New York Judge Joanna Seybert's Dec. 11, 2006 Order granting a preliminary injunction in RxUSA Wholesale, et al, v. FDA, barring FDA from enforcing some drug pedigree rules.

The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.

Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion. As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Rockville, MD (Dec. 12)-Citing serious safety concerns, the US Food and Drug Administration is ordering unapproved quinine drugs from the market, including those containing quinine sulfate and any quinine salt.

Rockville, MD (Dec. 12)-The US Food and Drug Administration is proposing amendments to its final rule regarding labeling requirements for convenience-size over-the-counter human drugs.

Bothell, WA (December 12)?If the shareholders of biotechnology company Icos Corp. approve a proposed buyout by Eli Lilly and Co., all of Icos?s 700 employees will lose their jobs.

Dec. 11, 2006 (Rockville, MD)-Effective Jan. 16, 2007, Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration, will leave the agency and will return to the American Enterprise Institute.

Abbott, Enanta, BASF, Celgene, More

Rockville, MD ( Dec. 4)-The U.S. Pharmacopeia plans to open a 10,500-square-foot site in Shanghai in February 2007. The facility, in Shanghai's Zhangjiang Hi-Tech Park, will support collaborative testing, technical assistance, customer service, and training.

3M, Actavis, Kos, Abbott, more

Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.

Proof of concept is a new development paradigm.

Ann Arbor, MI (Nov.15)-Scientists at University of Michigan?s Comprehensive Cancer Center have devised a nanoparticle system that delivers a photodynamic drug directly to brain-cancer tumors

AAI, Mallinckrodt, ATMI LifeSciences, More

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.

Actavis, Altus Pharmaceuticals, Covance, more

Alcan, China Biopharma, US FDA, MedImmune, more

Alcan, China BioPharma, Illumina, Solexa, more