This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

Drug development opportunities, specification development, and new vaccine technologies were highlighted at the AAPS National Biotechnolgy Conference in Boston this week. More than 1100 attendees from 19 countries participated in the event.

Pall Corporation (East Hills, NY) reported strong sales growth in its biopharmaceuticals business in the fiscal third quarter (ending April 30, 2006) and announced plans for a company-wide cost-savings program.

Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.

Avant, Barr, BASF, Degussa, Laureate Pharma, Millennnium Pharmaceuticals, Northfield Labs

Alpharma, Bayer, MicroTest, NexMed, Penwest

Preformulation represents an early-stage opportunity to facilitate the eventual movement of a drug substance into a commercial product. Strategies to optimize the preformulation process were outlined by Harry Brittain, institute director for the Center for Pharmaceutical Physics (Milford, NJ). He spoke at the PharmTech Annual Event in Somerset, New Jersey this week.

The ongoing battle between Bayer AG (Leverkusen, Germany) and Merck KGaA (Darmstadt, Germany) in their respective quests to acquire Schering AG (Berlin, Germany) was resolved this week, with Merck KGaA agreeing to sell its 21.8% stake in Schering to Bayer.

NPIL Pharma, a subsidiary of Nicholas Piramal India Limited (Mumbai, India) has agreed to acquire the Morpeth, Northumberland, UK, manufacturing facility of Pfizer Inc. (New York, NY).

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

Accurate characterization of active pharmaceutical ingredients (APIs) is a critical part of the drug development process. The approaches used to characterize APIs with respect to structure, identification of impurities, and the solid-state were discussed by Andrew C. Kolbert, manager, molecular structure and spectroscopy, Cardinal Health (Dublin, OH).

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

The US Department of Health and Human Services (HHS, Washington, DC) awarded biotech company Cangene (Winnipeg, MB, Canada) a $362-million Project Bioshield supply contract for 200,000 doses of botulinum toxin immune globulin (heptavalent botulism antitoxin).

The Parenteral Drug Association (PDA, Bethesda, MD) finished the second stage of GMP training for representatives from the Republic of Kazakhstan?s Ministry of Health.

Abemarle, Aceto, Nastech Pharmaceutical Company, Novartis, Novo Nordisk, PerkinElmer, Inc.

RNAi therapeutics company SR Pharma plc (London, UK) has developed a process that allows it proprietary liposomal-based siRNA formulations ?AtuRNAi? drugs to be stored at room temperature and reconstituted in one step.

Recombinomics (Pittsburgh, PA) is again urging the World Health Organization to fully release all H5N1 avian influenza sequences, claiming their release would improve the selection of vaccines by helping scientists to identify the origin of the isolates and predict sequence changes.

Degussa AG (D?sseldorf, Germany) and Lynchem Co., Ltd. (Dalian, Liaoning Province, China) signed a contract to establish a custom manufacturing joint venture.

Gilead Sciences, Inc. (Foster City, CA) signed a definitive agreement to acquire the Canadian subsidiary Raylo Chemicals and most of its assets from Degussa AG (D?sseldorf, Germany) for 115.2 million euros ($147 million).

Solutia Inc. (St. Louis, MO) announced that its subsidiary, Solutia Europe SA/NV (SESA), had reached a definitive agreement to sell its pharmaceutical services business, which comprises CarboGen AG and AMCIS AG. Under the terms of the agreement, Dishman Pharmaceuticals and Chemicals Ltd. (Ahmedabad, India) will purchase 100 percent of CarboGen and AMCIS stock and related assets for $74.5 million, subject to a working capital adjustment.

Noting several violations in current good manufacturing practice regulations, the US Food and Drug Administration has issued a Warning Letter to Wyeth Pharmaceuticals?s (Collegville, PA) manufacturing facility in Puerto Rico.

BASF, Bayer, NovaDel, Parexel, Schering

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.