BioPharm International Editors

The US Food and Drug Administration (Rockville, MA, www.fda.gov) commemorated its 100th anniversary in 2006 as America's premier public health agency aimed at protecting and promoting public health.

The Biotechnology Industry Organization (BIO, Washington, DC, www.bio.org) has elected Pfizer (New York, NY, www.pfizer.com) Chairman and CEO Jeffrey B. Kindler to BIO's board of directors.

Cougar Biotechnology, Inc. (Los Angeles, CA, www.cougarbiotechnology.com), has appointed Richard B. Phillips, PhD, as VP of regulatory affairs and quality assurance.

GlaxoSmithKline (London, UK, www.gsk.com) has announced clinical trial data from two new studies, which show that its pre-pandemic flu vaccine, formulated with GSK's proprietary adjuvant system, works against diverse strains of H5N1.

BioCryst Pharmaceuticals, Inc. (Birmingham, AL, www.biocryst.com) and Shionogi & Co., Ltd. (Osaka, Japan, www.shionogi.co.jp) have signed an exclusive license agreement to develop and commercialize BioCryst's lead influenza neuraminidase inhibitor, peramivir, in Japan for the treatment of seasonal and potentially life-threatening human influenza.

Vasogen, Inc. (Ontario, Canada, www.vasogen.com), has appointed Terrance H. Gregg to succeed David G. Elsley as president and CEO of Vasogen.

Sartorius AG (Goettingen, Germany, www.sartorius.com) has acquired a substantial stake in the biopharmaceutical supplier Stedim Biosystems S.A (Aubagne, France, www.stedim.com) and combined its biotechnology division with Stedim.

The Group of Seven (G7) industrialized nations plans to sign an agreement to provide $1.5 billion dollars to develop vaccines for diseases including HIV/AIDS, tuberculosis, and malaria that largely affect developing countries, reported Reuters on February 6, 2007.

Laureate Pharma (Princeton, NJ, www.laureatepharma.com) has signed an agreement with Boehringer Ingelheim (BI, Ingelheim, Germany, www.boehringer-ingelheim.com) for access to BI's comprehensive manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture.

Manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims, HHS announced on January 1.

Waters Synapt High Definition MS System from Waters Corporation (www.waters.com) is designed for researchers working at the limits of conventional mass spectrometry and who need to further characterize and define complex samples.

A new ?9.5 million R&D program has been launched by ITI Life Sciences (Dundee, Scotland, www.itilifesciences.com) to develop an automated process to produce high-quality human stem cells.

Wyeth Pharmaceuticals, a division of Wyeth (Madison, NJ, www.wyeth.com), has signed agreements with Nautilus Biotech (Evry, France, www.nautilusbiotech.com) and MediVas LLC (San Diego, CA, www.medivas.com), a biomaterials company specializing in improved delivery of biologics.

Oncolytics Biotech (Calgary, Canada, www.oncolyticsbiotech.com) has appointed Mary Ann Dillahunty as VP, Intellectual Property.

Pharmalink Consulting (Berkshire, UK, www.pharmalinkconsulting.co.uk) has named Paul Kuiken head of North America operations, based out of the New York office.

Baxter International (Deerfield, IL, www.baxter.com) has signed a Memorandum of Understanding with the government of Indonesia to provide a framework for future discussions and negotiations related to potential formal collaboration or supply agreements for pandemic vaccines.

Vincent F. Simmon, PhD, has joined Xytis Pharmaceuticals, Inc. (Irvine, CA, www.xytis.com) as president, CEO, and member of the board of directors.

Eli Lilly and Company (Indianapolis, IN, www.lily.com) has announced several strategic changes to its global manufacturing operations to better support the company's current product portfolio and evolving drug pipeline.

Two Baxter International Inc. (Deerfield, IL, www.baxter.com) manufacturing facilities will be recognized with the 2007 Shingo Prize for Excellence in Manufacturing. Baxter's North Cove facility in Marion, NC, and its Cuernavaca facility in the Mexican state of Morelos, are being honored for their achievements in driving higher quality and improvements in productivity, manufacturing cycle time, and customer lead time.

Pfizer Inc. (New York, NY, www.pfizer.com) will acquire BioRexis Pharmaceutical (Pennsylvania, PA, www.biorexis.com) Corporation, a privately-held biopharmaceutical company with a number of diabetes candidates and a novel technology platform for developing new protein drug candidates.

The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls.

GlaxoSmithKline (London, UK, www.gsk.com) has been awarded a $63.3-million contract from the US Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines.

The Biotechnology Council of New Jersey (Trenton, NJ, www.biotechnj.org) has elected three new members to its board of trustees.

Dr. Uwe Gottschalk, vice president of purification technologies at Sartorius AG (Goettingen, Germany, www.sartorious.com) and member of BioPharm International's editorial advisory board, will now also be a lecturer at the University of Duisburg-Essen, for the first Master's degree program in pharmaceutical medicine.

The Canadian biotechnology company SemBioSys Genetics Inc. (Calgary, AB, www.sembiosys.com) will proceed with an abbreviated regulatory path for its proprietary plant-produced insulin, which has been demonstrated in animal models to be chemically, structurally, and functionally equivalent to US pharmaceutical-grade human insulin.

Daronrix, GlaxoSmithKline (GSK) Biologicals' (London, UK, www.gsk.com) first-generation, alum-adjuvanted, inactivated, whole-virus candidate flu vaccine for one-time use in a pandemic has received a positive opinion from Europe's Committee for Medicinal Products for Human Use.

The KrosFlo Research II TFF System from JM Separations (www.jmseparations.com)is suitable for performing and monitoring the filtration of volumes ranging from 2 mL to 10 L.

Genentech (San Francisco, CA, www.genentech.com) and Seattle Genetics, Inc. (Bothell, WA, www.seattlegenetics.com) have signed an exclusive worldwide license agreement to develop and commercialize SGN-40.

The FDA has approved MedImmune's (Gaithersburg, MD, www.medimmune.com) new refrigerated formulation of FluMist (influenza virus vaccine live, intranasal), which is used to help prevent influenza in healthy children and adults from 5 to 49 years of age.

Pharmaceuticals giant Novartis (Basel, Switzerland, www.novartis.com) has chosen Cambridge, MA, as the global headquarters for its vaccines and diagnostics division.