BioPharm International Editors

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

Acambis plc (Cambridge, UK) has appointed Elizabeth Jones chief financial officer (CFO) and an executive director of the board.

Sanofi Pasteur (Lyon, France) has announced positive results from Phase 2 trials of its dengue vaccine candidate based on technology licensed from Acambis plc (Cambridge, UK).

Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1.

Wyeth (Madison, NJ) has elected Bernard Poussot president and chief executive officer (CEO), effective January 1, 2008.

Sanofi Pasteur (Lyon, France) has produced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, has announced a $29-million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel

The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology.

Bristol-Myers Squibb (Princeton, NJ) will acquire privately held Adnexus Therapeutics (Waltham, MA), the developer of a new therapeutic class of biologics called Adnectins.

Idenix Pharmaceuticals, Inc. (Cambridge, MA), has announced a strategic restructuring and an amended collaboration agreement with Novartis Pharma AG related to Sebivo (also marketed as Tyzeka), an oral treatment for patients with chronic hepatitis B.

Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination.

Steven Galson, MD, has been appointed acting surgeon general beginning October 1, 2007.

Sandoz (Holzkirchen, Germany), a division of the Swiss pharmaceutical company Novartis, has become the first company to receive European Commission approval for a biosimilar of epoetin alpha.

Cees de Jong will take the position of Chief Operating Officer at Crucell N.V. (Leiden, The Netherlands, cws.huginonline.com).

The BIOSTAT Cultibag RM is a disposable bioreactor that combines rocking motion mixing technology with Sartorius engineered control capabilities.

Jerzy Gruhn has been appointed president of the US affiliate of Novo Nordisk Inc., (Princeton, NJ, www.novonordisk.com), and senior vice president of Novo Nordisk North America.

Small biotechnology companies often need guidance during the development of new therapies-particularly when it comes to manufacturing.

PDL BioPharma (Fremont, CA), has announced that three-month internal investigation of the company's chief executive officer (CEO), Mark McDade, found no credible evidence to substantiate the allegations made by shareholders.

MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), has licensed its proprietary reverse genetics intellectual property to Novartis (Basel, Switzerland, www.novartisvaccines.com), to support the development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic, and pandemic influenza vaccines.

Theresa Mullin, PhD, will join CDER on September 24, 2007, as the associate director for analysis and strategic initiatives.

Eden Biodesign Limited, (Liverpool, UK, www.edenbiodesign.com), and Borean Pharma (Aarhus, Denmark, www.boreanpharma.com), have signed an agreement under which Eden will manufacture MBP-DC-SIGN, a novel therapeutic candidate for the treatment of a range of cancers, for Borean to use in preclinical studies.

According to a new report published by Informance International (Chicago, IL, www.informance.com/pharmstudy, registration required), high performance pharmaceutical manufacturers outpace their peers in operational metrics such as asset utilization, overall equipment effectiveness, and operational availability by identifying and measuring key performance indicators in and across facilities on an ongoing basis.

ISPE (Tampa, FL), a not-for-profit association of pharmaceutical manufacturing professionals, has just released its latest technical publication, "GAMP Good Practice Guide: Electronic Data Archiving."

Microbix Biosystems Inc. (Toronto, Canada, www.microbix.com), is establishing a special workgroup for applied technology transfer (SWATT) that will help manufacturers significantly boost the amount of flu vaccine produced throughout the world.

Frank A. D'Amelio has been named senior vice president and chief financial officer of Pfizer (New York, NY, www.pfizer.com), effective in mid-September.

Baxter International Inc., (Deerfield, IL, www.baxter.com), has entered into an advanced supply agreement with the Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization (WHO) declares a pandemic.

LFB (Les Ulis, France, www.lfb.fr) plans to incrementally acquire MAbgène (Alés, France, www.mabgene.com), through the development of a new entity for €6 million.

The US Food and Drug Administration (FDA) has approved the ACAM2000 vaccine made by Acambis (Cambridge, UK, www.acambis.com), for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.