BioPharm International Editors

A vaccine against the most common and deadliest strain of avian flu, H5N1, has produced a strong immune response in mice and protected them from death following infection.

James A.D. Smith, president, chief executive officer, and director of Genelabs Technologies, Inc. (Redwood City, CA) has resigned.

Bayer HealthCare (Leverkusen, Germany) has withdrawn the current liquid formulation of Leukine marketed in the US following consultation with the US Food and Drug Administration (FDA).

Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), biosimilars, or biogenerics.

Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices.

Venture capitalists will largely direct their investments to the greentech and biotech industries in the coming year.

Sinovac Biotech Ltd., (Beijing, China), has announced positive results of a completed Phase 2 clinical trial of its pandemic influenza (H5N1) whole viron inactivated vaccine.

The Parenteral Drug Association (PDA, Bethesda, MD) has announced its 2008 board of directors and officers.

Hawaii Biotech, Inc., (Honolulu, HI), has been notified by the United States Food and Drug Administration (FDA) that it may initiate a 24 patient safety study in healthy human volunteers with its recombinant, subunit West Nile vaccine.

BioPharm International’s second annual salary survey assesses not only how much people earn, but also how they feel about it.

The US Food and Drug Administration has published for public review and comment two annexes to the International Conference on Harmonization’s (ICH) Q4B guideline, Evaluation of Pharmacopeial Texts for Use in the ICH Regions.

The International Conference on Harmonization has released an Annex to its Q8 guideline, Pharmaceutical Development.

The US Food and Drug Administration is soliciting public comments on the report issued by the Science Board Advisory Committee on December 3, 2007.

Crucell NV (Leiden, The Netherlands), has announced that it will receive up to $5 million from the Aeras Global TB Vaccine Foundation (Rockville, MD), to support the development of its AdVac- and PER.C6-based tuberculosis vaccine candidate.

Acambis plc (Cambridge, MA), has announced that, subsequent to the US Centers for Disease Control and Prevention (CDC) order of September 2007, it completed delivery of the entire 2.7 million doses of its ACAM2000 smallpox vaccine to the CDC on December 28, 2007.

Crucell N.V. (Leiden, the Netherlands) has signed an exclusive collaboration and commercialization agreement with Sanofi Pasteur (Lyon, France) for Crucell’s rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

Merck Serono (Geneva, Switzerland), a division of Merck KGaA, will collaborate with Flamel Technologies (Lyon, France) to investigate the applicability of Flamel’s Medusa technology for the extended release of a therapeutic protein in Merck Serono’s portfolio.

Nektar Therapeutics (San Carlos, CA) will work with subsidiaries of Baxter International, Inc. (Deerfield, IL), to develop new PEGylated therapeutics for hemophilia.

Apitope Technology Ltd. (Bristol, UK), has announced the completion of dosing for all six multiple sclerosis (MS) patients in a Phase 1/2a trial of ATX-MS-1467

AM2 PAT, Inc., (Angier, NC) has initiated a nationwide recall of one lot of prefilled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.

On December 26, 2007, President Bush signed into law H.R. 2764, which gives the FDA nearly $1.73 billion in funding for fiscal 2008.

The FDA has announced that it is seeking a director for the Center for Drug Evaluation and Research (CDER).

International Society for Pharmaceutical Engineering (ISPE, Tampa, FL), a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has announced its 2007 award winners.

Nashville–based GenHunter Corporation has been granted a US patent (7,268,116) for a new protein expression technology.

Maxygen, Inc. (Redwood City, CA), has announced the licensing of its proprietary dengue virus antigen technology to Sanofi Pasteur (Lyon, France).

MorphoSys AG (Munich, Germany) and Novartis (East Hanover, NJ) have formed a comprehensive strategic alliance for the discovery and development of biopharmaceuticals.

Under a new agreement with ProGenetics LLC (Blacksburg, VA), GTC Biotherapeutics (GTC, Framingham, MA) will expand its portfolio to include protein therapeutics produced in the milk of transgenic pigs.

The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs).

Eden Biodesign, Ltd. (Liverpool, UK), has appointed Derek Ellison, PhD, vice president of development and manufacturing. Ellison, a co-founder of Eden, had previously held the title of business development director.

Sartorius Stedim Biotech has developed SARTOFLOW Alpha plus, a flexible modular benchtop crossflow filtration system, which provides semi-automatic micro-, ultra-, and diafiltration, and is especially suited for process development, clinical testing, and smaller production processes.