Pharmaceutical Technology Editors

FDA conducted 163 inspections of foreign API manufacturers in 2005.

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'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.

Cambrex Corp. signed a definitive stock-purchase agreement to sell two of its human-health facilities to a holding company controlled by International Chemical Investors II S.A. (Frankfurt, Germany).

Boehringer Ingelheim, Chemir Analytical Services, Millennium Pharmaceuticals

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

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

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.

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.

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

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.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

Amgen, Ash Stevens, Aveo, Millipore

London (Sept. 29)-GlaxoSmithKline will invest more than ? 500 million in a vaccine-manufacturing plant in St-Amand-Les-Eaux, France. The investment will expand the company?s production capacity in formulation, filling, freeze-drying, and packaging in response to increasing worldwide demand for pediatric and adult vaccines.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.

Bentley, Cardinal, Saltigo, Sanofi pasteur

UCB SA has offered EUR 4.4 billion ($5.64 billion) in cash and stocks to acquire Schwarz Pharma AG.

In a move that continues the consolidation trend in the generic drugs market, Hospira Inc. agreed to acquire specialty injectables company Mayne Pharma Limited (Melbourne, Australia) for $2 billion.

Millennium Pharmaceuticals, Inc. entered into an agreement to acquire biopharmaceutical company AnorMED, Inc. (Langley, BC, Canada) for $515 million.

Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.

Altana AG plans to sell Altana Pharma AG and its entire pharmaceuticals business to Nycomed for EUR 4.5 billion (about $5.7 billion).

FDA issued a Warning Letter from its Minneapolis District Office to Hawkins, Inc., part of a diversified chemical company and pharmaceutical repackager here.

As with pharmaceutical manufacturing as a whole, a risk-based approach is important in manufacturing highly hazardous or potent compounds. Industry groups are working with US Food and Drug Administration (Rockville, MD) to develop a baseline guide for a risk-management approach to determine containment controls required to minimize cross contamination.

Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America upon the resignation of Peter R. Dolan.

AstraZeneca, Schering AG, Bioxel Pharma

Specialty Pharmaceutical Company Bentley Pharmaceuticals has entered into an agreement with Cardinal Health for the scale-up of clinical supplies for Bentley's intranasal insulin product candidate.

Baltimore, MD (Sept. 10)-Researchers at Johns Hopkins University have devised a new controlled-delivery system that applies an electrical pulse to release drug molecules, nanoparticles, biopolymers such as peptides and proteins, and protein assemblies such as viruses from thin fabricated gold electrodes. Developers hope the technique will allow biocompatible implantable chips for precisely dispensing small amounts of drug into the body.