News

Sandoz (Holzkirchen, Germany), the generics arm of Novartis (Basel, Switzerland), received approval from the US Food and Drug Administration (Rockville, MD) for "Omnitrope" (somatropin [rDNA origin]), a follow-on version of a previously approved recombinant human growth hormone (rhGH) product.

Bristol-Myers Squibb Company (BMS, New York, NY) selected Devens, Massachusetts as the site for its new, large-scale, multiproduct bulk biologics facility.

China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.

The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .

Schering-Plough Corporation (Kenilworth, NJ) announced plans to phase out manufacturing operations at its Manati, Puerto Rico site, expecting to discontinue operations there by the end of 2006.

On May 26, AstraZeneca (Wilmington, DE) announced it would invest $100 million in research and development in China over the next three years.

I always suspected that our purchasing manager had agreed to this just to save money . . .

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Pharmaceutical Science & Technology News

Does "personalized medicine" mean personalized treatment or personalized molecules, custom made for a patient's specific biology?

To fully optimize MS performance, corresponding enhancements are required in the other functional components of the integrated LC/MS platform.

This column provides a summary of the key trends that are occurring within pharma–biotech alliances, as well as looking at biotech–biotech. It will explore the changing balance of power in pharma and biotech deals, providing examples and insights into which areas alliances are becoming increasingly popular.

Xethanol Corporation's (New York, NY) subsidiary CoastalXethanol signed a letter of intent with Pfizer Inc. (New York, NY) to purchase Pfizer's pharmaceutical manufacturing complex in Augusta, Georgia.

Abraxis BioScience Inc., Bristol-Myers Squibb Company, Cambrex Corporation, Sigma-Aldrich Corporation, SkyePharma

Rutgers, the state university of New Jersey (New Brunswick, NJ), the New Jersey Institute of Technology (Newark, NJ), Purdue University (West Lafayette, IN), and the University of Puerto Rico (Mayag?ez, PR) won a $15-million, five-year grant from the National Science Foundation (Arlington, VA) to improve the manufacturing of pharmaceuticals, food, and agricultural products.

The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.

Chemir Analytical Services (Maryland Heights, MO) acquired Gateway Chemical Technology, Inc., (St. Louis, MO), a provider of custom synthesis and process development services.

Spectrum Laboratory Products (Gardena, CA) recalled its active pharmaceutical ingredient, tacrolimus, after learning that some lots of the ingredient are subpotent. At least one injury has been reported.

Research and Markets (Dublin, Ireland) has released ?Annual Investment Analysis Report of the Chinese Pharmaceutical Logistics Industry, 2005-2006.? The report provides analysis of the pharmaceutical logistics characteristics, conditions, pharmaceutical market and pharmaceutical retail dynamics.

The US Food and Drug Administration (Rockville, MD) seeks volunteers to take part in a pilot project to test a Health Level 7 (HL7) data-interchange standard for submitting product stability data.

Boehringer Ingelheim, Crucell, Eisai, Laureate Pharma, Pall Corp., Tunnell Consulting

AstraZeneca PLC (London, England) has agreed to acquire the biopharmaceutical company Cambridge Antibody Technology Group PLC (CAT, Cambridge, England).

Roche (Basel, Switzerland) has entered into a nonexclusive agreement with Aspen Pharmacare (Port Elizabeth, South Africa) to speed up production and supply of a generic version of oseltamivir ("Tamiflu") for Africa.

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER, Rockville, MD) formally put into action its reorganization plan, effective May 15.

Seven automation suppliers have joined with users on the Instrumentation, Systems, and Automation Society (ISA, Research Triangle Park, NC) "Wireless Standards for Automation (SP100)" committee to develop wireless network structures for manufacturing plants.

Merck & Co Inc. (Whitehouse Station, NJ) has agreed to acquire two biologics companies: GlycoFi Inc. (Lebanon, NH), a specialist in yeast glycoengineering for $400 million, and the biopharmaceutical company Abmaxis Inc. (Santa Clara, CA) for $80 million.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Johnson & Johnson, Mesa Labs, Mar Cor, FDA, Andrx

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

On May 8, Thermo Electron Corporation (Waltham, MA) and Fisher Scientific International Inc. (Hampton, NH) announced they would merge in a tax-free, stock-for-stock exchange.