FDA conducted 163 inspections of foreign API manufacturers in 2005.

The reason for reading the report is to inoculate ourselves against error.

Branded pharmaceutical companies have long been immune to the cost pressures faced in other industries. With robust research and development pipelines, long periods of patent protection to ensure continued high margins, and a regulatory environment that has virtually eliminated the threat of overseas competition, pharmaceutical companies have traditionally considered spend management an afterthought. Recent changes in the pharmaceutical industry, however, have begun to erode Big Pharma's once-imperious position.

While e-mail is quick and convenient, it's too easy to hide behind and, ultimately, faceless.

Applied Biosystems, Aptuit, Barr, Bioenvision, Bioject, Bionomics, Charles Ross, Connetics, Curalogic, Cytogen, Doxa, Eli Lilly, FDA, Imclone, Laureate, Luciano Packaging, Microtest, Orexo, PLIVA, SAFC, Sanofi-Aventis, SSCI, SSI, Stiefel, Teva

Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases.

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Growth in the global pharmaceutical market is expected to slow in 2007, based on the industry's increasing reliance on niche and specialty products and greater generic drug penetration, according to a forecast by IMS Health. Generic drugs, along with biotechnology and specialist-initiated products, are expected to outperform the overall market in 2007. Despite slower growth in the United States and Europe, growth in emerging countries, including China, is projected in the double digits.

The US Food and Drug Administration's Center for Drug Evaluation and Research executed 45 Class I, 193 Class II, and 128 Class III recalls of human drugs between Oct. 1, 2005 and Sept. 30, 2006.

Boehringer Ingelheim, Chemir Analytical Services, Millennium Pharmaceuticals

Indianapolis, IN (Oct. 17)-Eli Lilly and Company agreed to acquire ICOS Corporation (Bothell, WA) for $2.1 billion.

Washington, DC (Oct. 13)-In a four-year study of pharmaceutical manufacturing, two business scholars found that initiative and information correlate with high productivity.

New York, NY (Oct. 19)-Pfizer, Inc. plans to implement a new company-wide cost-cutting initiative in 2007 as part of strategy to improve operating performance. The cuts are in addition to a previous cost-reduction program that Pfizer launched in 2005.

CPhI Worldwide, Paris (Oct. 3)-Archimica, participating in its first CPhI Worldwide exhibition since being launched as new company earlier this year, outlined manufacturing expansions, technology additions, and recent projects at its facilities in the United States and Europe.

CPhI Worldwide, Paris (Oct. 3-5)-CPhI Worldwide, the large exhibition of pharmaceutical ingredient suppliers held in Paris last week, revealed two important themes.

Langley, BC, Canada (Oct. 10)-AnorMED Inc. has determined that Genzyme's US $580 million offer to acquire all outstanding AnorMED shares at US $13.50 a share is a "superior proposal."

Altana, Macroflux, Pfizer CentreSource

CPhI Worldwide, Paris (Oct. 3)-The Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field.

Cramlington, UK (Oct. 9)-Aesica, a supplier of active pharmaceutical ingredients (APIs), announced it had acquired a chemical-manufacturing facility at Ponders End, UK from Merck Sharp and Dohme Limited, the British subsidiary of Merck and Co., Inc.

CPhI Worldwide, Paris (Oct. 3)-Exhibitors at CPhI Worldwide reported expansions, enhancements in technology, and new projects last week in Paris.

CPhI Worlwide, Paris, (Oct. 5)-Following its recently announced acquisition of EaglePicher Pharmaceutical Aptuit, Inc. plans further investment in infrastructure and staff in building its capabilities in manufacturing active pharmaceutical ingredients (APIs).

CPhI Worldwide, Paris (Oct. 3)-Carbogen Amcis AG, a subsidiary of Dishman Pharmaceuticals and Chemicals Ltd., is planning several investments in its pharmaceutical chemical development and manufacturing activities.

New York (Oct. 9)-Pfizer has positioned itself to enter the DNA-based vaccine market with its agreement to acquire UK-based PowderMed Ltd., which holds a pipeline of DNA-based influenza vaccines currently in clinical development for treating both seasonal and avian flu.

CPhI Worldwide, Paris (Oct. 3)-NPIL Pharma has formed a new dedicated unit, NPIL Innovations or NPIL(i), to focus on developing and applying new technologies used in process development and production of active pharmaceutical ingredients (APIs).

Foster City, CA (Oct. 2)-Gilead Sciences, Inc. has agreed to acquire the biopharmaceutical company Myogen, Inc. for $2.5 billion.

Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

SAFC, the custom manufacturing group of Sigma-Aldrich Corporation, announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.