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

Indianapolis, IN (Jan. 11)-Eli Lilly and Company announced several strategic changes to its global manufacturing operations. The changes include termination of construction of a planned insulin manufacturing plant in Virginia, staff reductions in its operations for small-molecule active pharmaceutical ingredients (APIs), and investments in manufacturing biotech-based drug products

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.

Berlin and Leverkusen, Germany (Dec. 29)? Bayer Schering Pharma AG was officially launched as a new company following the acquisition of Schering AG (Berlin, Germany) by the Bayer Group (Leverkusen, Germany).

ARmark, Chattem, Johnson & Johnson, more.

Stockholm, Sweden (Dec. 15)-As part of a plan to expand its biotechnology production capacity, Pfizer, Inc. commissioned the construction company Skanska AB to build a plant in Strangnas, Sweden for manufacturing Pfizer's human growth hormone product "Genotropin" (somatropin [rDNA origin] for injection).

Hafnarfjordur, Iceland (Dec. 21)-The generic drug manufacturer Actavis Group is expanding its manufacturing capabilities in India and plans to close a facility in Norway.

The recent struggles of Cardinal Health's and Patheon's contract dose manufacturing businesses offer a lesson on good business practices.

Industry will be challenged to embrace new methods of supply chain collaboration.

The closing presentation was perfectly pitched to bring a lump to our throats and have us cheering for fast-track drug development. I and 30 other journalists had spent the day touring a Big Pharma plant, and now sat shoulder to shoulder in a warm conference room, awaiting the final speaker.

Ninety million people live in California, Texas, New York, and Florida. Imagine that, sometime tonight, an unnameable catastrophe carries off everyone in those states over the age of 14. When the sun comes up tomorrow, only the children remain. Eighteen million children, left to care for one another or fend for themselves.

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

The production staff was sure the lab couldn't test their way out of a paper bag.

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.

Astellas Pharma Inc. (Tokyo) will sell three European plants to the Temmler Group (Marburg, Germany), a pharmaceutical company and contract manufacturer. The move is part of Astellas's plan to reduce the number its production sites.

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.

The Dow Chemical Company (Midland, MI) has agreed to acquire Wolff Walsrode, a manufacturer of cellulose products and a business unit of the Bayer Group (Leverkusen, Germany, www.bayer.com).