Pharmaceutical Technology Editors

London, UK (Feb. 1)?Researchers at the University of London?s School of Pharmacy have chemically modified carbon nanotubes to enable them to enter human cancer cells.

Cambrex, Lonza, EaglePicher, more

Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

The injunction blocks rules that required secondary wholesalers to supply pedigrees tracing the chain of custody to the maker.

Akorn, PrimaPharm, ARTEL, FMC, more

Rockville, MD (Jan. 30)?-In response to a set of recommendations made by the Institute of Medicine, the US Food and Drug Administration issued a report detailing a series of initial steps to improve its safety programs.

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

The US Food and Drug Administration announced the creation of the Office of the Chief Medical Officer as well as two important staff changes at the agency.

Abbott, SAFC Pharma, More

Acambis, Baxter, NovoNordisk, more

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