BioPharm International Editors

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has announced that the reorganization of the Office of Surveillance and Epidemiology (OSE) has been completed.

Franz B. Humer has stepped down as chief executive officer (CEO) of the Roche Group (Basel, Switzerland), after holding that title for 10 years.

PDL BioPharma, Inc. (Redwood City, CA) announced on March 4, 2008 that it will no longer actively pursue the sale of the company or of its biotechnology discovery and development assets.

Laureate Pharma, Inc. (Princeton, NJ), has appointed Gary Swan vice president of operations.

Pfizer, Inc. (New York, NY) will acquire Serenex, Inc. (Durham, NC), a biotechnology company with a Phase 1 clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), a target in the fight against cancer.

Sangamo BioSciences, Inc. (Richmond, CA) has entered into a second research and license agreement with Genentech, Inc. (South San Francisco, CA), expanding on the original agreement to include additional targets for potential improvement of production cell lines using Sangamo's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology

A recent study conducted by scientists at NanoBio Corporation (Ann Arbor, MI) and the University of Michigan (Ann Arbor, MI) has demonstrated that their nasally delivered vaccinia vaccine can protect animals against 77 times the potentially lethal dose of smallpox, and without the safety risks of current vaccines for smallpox.

EUSA Pharma (Oxford, UK) has out-licensed the exclusive worldwide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK, Middlesex, UK) for consideration of up to $44 million

Saint-Gobain Performance Plastics Corporation (Aurora, OH) has acquired the assets of J & J Scientific Products, Inc. (Tampa, FL), a manufacturer of disposable plastic products for the biopharmaceutical market.

Novozymes (Bagsvaerd, Denmark) will collaborate with Upperton Limited (Nottingham, UK), a company specializing in novel nanoparticle-based drug delivery systems.

Sanofi Pasteur (Lyon, France) has shipped six million doses of its Stamaril yellow fever vaccine in response to the to the yellow fever epidemic in Latin America.

On March 10, 2008, US Food and Drug Administration Commissioner Andrew von Eschenbach, MD, announced that Janet Woodcock, MD, has been appointed director of the agency's Center for Drug Evaluation and Research (CDER), following a national search.

ESBATech AG (Zurich, Switzerland) has achieved high concentrations of its antibody fragments in all segments of the eye with topical delivery via eye drops.

Most small and mid-size biopharmaceutical companies still handle most regulatory filings on paper, recent industry research shows, despite the fact that larger companies and regulators are rapidly shifting toward an electronic environment.

German authorities have received a cluster of reports of adverse reactions to heparin products that are similar to the reactions previously reported to the US FDA, causing the German authorities to initiate a recall of heparin products.

The FDA has found what it is calling a "heparin-like" compound in the API of heparin that is not heparin.

Following the partial recall initiated on January 25, 2008, Baxter Healthcare has expanded its recall of heparin.

On February 21, 2008, a congressional committee sent letters to Baxter Healthcare and the FDA seeking information related to the recent heparin recall.

Genentech has been notified that their Cabilly patent claim has been rejected by the US Patent and Trademark Office.

Polyplus-transfection (New York, NY), has announced the production of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practices (GMPs).

Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of its rabies vaccine (RabAvert) and diphtheria and tetanus toxoids adsorbed concentrate (without preservative), with regard to bulk lot production and process controls and investigations.

Cobra Biomanufacturing Plc (Keele, UK) has entered into a manufacturing development agreement with GenVec, Inc. (Gaithersburg, MD) for TNFerade.

Eli Lilly and Company (Indianapolis, IN) has completed its licensing and development agreement with BioMS Medical Corp. (Edmonton, Alberta, Canada).

Robert F. Friel has been elected chief executive officer of PerkinElmer, Inc. (Waltham, MA).

Venture capitalists will largely direct their investments to the greentech and biotech industries in the coming year, while China and India remain hot destinations for venture funds, according to a recent survey by the auditing firm KPMG.

Laureate Pharma, Inc. (Princeton, NJ) has entered into a cGMP contract manufacturing agreement with ARIUS Research, Inc. (Toronto, Canada) for its Trop-2 signal transduction antibody program.

BioProfile® FLEX can reduce cell culture analysis time, labor, and operating costs by consolidating up to 15 key cell culture attributes – including chemistry/gases/electrolytes, cell density/viability, and osmolality -- into a single, easy-to-use workstation.

Eden Biodesign Ltd. (Liverpool, UK) and iQur Ltd. (Southampton, UK) have entered into an agreement to develop iQur’s tandem core vaccine for hepatitis A and B.

Sheldon Berkle has resigned as president, chief executive officer, and member of the board of directors of Altus Pharmaceuticals, Inc. (Cambridge, MA).

A needle-free vaccine platform that elicits a robust immune response against a wide array of viruses and bacteria has been awarded a US patent (#7,314,624 B2), held by the University of Michigan (Ann Arbor, MI).