News

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.

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.

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).

One of the last acts of former Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration (FDA).

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.