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Susan C. Winckler has been named the agency's acting chief of staff.

Lipoxen PLC (London, UK, www.lipoxen.co.uk) has agreed to license its "PolyXen" drug delivery technology to Baxter International Inc. (Deerfield, IL, www.baxter.com) to develop improved, longer-acting forms of Baxter's blood-clotting factors, such as Factor VIII.

Roche (Basel, Switzerland, www.roche.com) will apply the "Enhanze" technology of Halozyme Therapeutics (San Diego, CA, www.halozyme.com) to its biological therapeutic compounds.

Genentech, Inc. (San Francisco, CA, www.genentech.com) and AC Immune, Ltd. (Lausanne, Switzerland, www.acimmune.com), a Swiss Biotech company developing therapies against Alzheimer's disease, have entered into an exclusive global license agreement and research collaboration for the development of anti-beta-amyloid antibodies for the potential treatment of Alzheimer's disease and other human diseases.

The biopharmaceutical industry's identity management community has advanced significantly in the last year, as demonstrated by several member companies of SAFE-BioPharma Association, the non-profit association that manages the Signatures and Authentication For Everyone (SAFE) digital identity and signature standard.

Invitrogen (San Diego, CA, www.invitrogen.com) believes that scaledown technologies can significantly improve clone selection and cell culture media development.

William Fallon has been appointed vice president of manufacturing and operations for Halozyme Therapeutics, Inc. (San Diego, CA, www.halozyme.com).

Introgen Therapeutics (Austin, TX, www.introgen.com) has acquired a new license from the University of Texas MD Anderson Cancer Center for a nanotechnology delivery system, covered by US Patent application 20060251726, dated November 9, 2006, for proteins and peptides.

Generex Biotechnology Corporation (Toronto, Canada, www.generex.com) has received an Australian patent for its micellar system for delivering macromolecules through the buccal lining.

An old saying goes, "Success has a thousand fathers; failure is an orphan."

Dr. Arzu Selen joins FDA's Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics.

Genentech (South San Francisco, CA, www.gene.com) announced on November 9 that it will acquire Tanox, Inc. (Houston, TX, www.tanox.com), a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology.

Dr. Roberto Machuca has been named operations manager at Ace BioSciences (Odense, Denmark, www.acebiosciences.com).

A recent study by the Tufts Center for the Study of Drug Development (CSDD, http:csdd.tufts.edu) shows that development costs are higher for biotechnology products than previously estimated development costs for traditional pharmaceuticals.

Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com) will purchase Sirna Therapeutics (San Francisco, CA, www.sirna.com), a biotechnology company developing a new class of medicines based on RNA interference (RNAi) technology, for $1.1 billion.

Lyle Flom has been promoted to senior director of site operations for San Antonio at DPT Laboratories, Ltd. (San Antonio, TX, www.dptlabs.com).

William Slikker, Jr., PhD, has been appointed Director for the National Center for Toxicological Research (NCTR, www.fda.gov/nctr).

The US Food and Drug Administration (FDA) issued a new guidance September 28 to help manufacturers develop safe and effective cell-based viral vaccines.

Gilead Sciences, of Foster City, CA (www.gilad.com), has agreed to acquire Myogen for about $2.5 billion, a move aimed at gaining ownership of Ambrisentan, a treatment for pulmonary arterial hypertension that is in late-stage clinical trials.

Dutch biotechnology company Crucell N.V. (Leiden, The Netherlands, www.crucell.com) has purchased Florida-based Berna Products Corp. from Acambis.

The US Food and Drug Administration says the final version of "Quality Systems Approaches to Pharmaceutical Good Manufacturing Practice (cGMP) Regulations," issued September 29, will help manufacturers maintain consistent high quality while allowing them to make technological improvements more easily.

GTC Biotherapeutics (Framingham, MA, http://www.gtc-bio.com) and LFB Biotechnologies (France) have signed an agreement to collaborate in the development of selected recombinant plasma proteins and monoclonal antibodies using GTC's transgenic production platform.

Pfizer has agreed to purchase PowderMed (London, England, www.powdermed.com), a British company that develops DNA-based vaccines.

XOMA Ltd. (Berkeley, CA, http://www.xoma.com) and Affimed Therapeutics AG (Heidelberg, Germany, www.affimed.com) have signed a cross-license and collaboration agreement for antibody-related technologies.

Malcolm Rollins, PhD, has been appointed manager of projects and process development at QSV Biologics (www.qsvbiologics.com).

A new pharmaceutical industry benchmarking study found that better manufacturing performance results when operations staff make key decisions.

Leonard Kanavy joins Genentech (www.gene.com) as vice president of commercial operations.

A new biotech consortium in the UK believes it can develop tools to improve biopharmaceutical process development.

Celsis International plc (Chicago, IL, www.celsis.com) has acquired In Vitro Technologies, Inc. (Baltimore, MD, www.invitrotech.com).

Pfizer (New York, NY, www.pharmtech.com) will license TransTech Pharma's (High Point, NC, www.ttpharma.com) portfolio of large- and small-molecule compounds that target the receptor for advanced glycation end products (RAGE), which have potential use in treating Alzheimer's disease.