BioPharm International Editors

Genentech, Inc. (San Francisco, CA, www.genentech.com) has announced the promotions of four vice presidents to senior vice presidents, and the appointment of a new vice president.

Dr. Janet Woodcock will be the chief medical officer at the US Food and Drug Administration (Rockville, MD, www.fda.org).

In its Outlook 2007 report on pharmaceutical and biotech development, the Tufts Center for the Study of Drug Development (CSDD) says drug developers should be optimistic despite a growing list of development challenge including rising R&D costs, increasing regulatory stringency, and mounting public hostility over safety and end-user costs.

Acambis (Cambridge, UK, www.acambis.com) successfully delivered 10 million doses of ACAM2000 smallpox vaccine to the US Centers for Disease Control and Prevention in December 2006, generating revenue of approximately ?16 million, which will be recognized in the last quarter of 2006.

The world's two largest biotechs, Amgen (Thousand Oaks, CA, www.amgen.com) and Genentech (San Francisco, CA, www.genentech.com), have just announced deals to develop small-molecule drugs with respective partners.

The Food and Drug Administration (Rockville, MD, www.fda.org) has announced a public meeting on February 7, 2007, to solicit comments that FDA should consider when developing revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements, and other changes to approved marketing applications for human drugs.

Elusys Therapeutics, Inc. (Pine Brook, NJ, www.elusys.com), a biotechnology company developing targeted anti-infective antibodies to fight life-threatening infections, has entered into an exclusive collaborative research and license agreement with Pfizer, Inc. (New York, NY, www.pfizer.com) to develop new therapeutics for select infectious diseases using Elusys's HP antibody technology.

The Department of Health and Human Services (HHS) has awarded contracts to three drug makers - Sanofi Pasteur, Novartis and GlaxoSmithKline - for $199.5 million more worth of vaccines against the H5N1 avian influenza virus.

Lonza Group Ltd. (Basel, Switzerland, www.lonza.com) and Bio*One Capital (Centros, Singapore, www.bio1capital.com) have signed a joint venture - Lonza Biologics Tuas - to build a large-scale mammalian cell culture facility in Singapore for the manufacture of commercial biopharmaceuticals.

John Fess has been appointed chief executive officer of Blue Heron Biotechnology (Bothell, WA, www.blueheronbio.com).

Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration (Rockville, MD, www.fda.org), will leave the agency effective January 16, 2007.

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

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.

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.

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.

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).