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.
Lancaster Laboratories Inc., (Lancaster, PA, www.lancasterlabs.com), part of Thermo Fisher Scientific Inc., (Walthan, MA), has acquired Microchem Laboratories, located in County Waterford, Ireland.
A new DNA vaccine made by Bayhill Therapeutics (Palo Alto, CA, www.bayhilltherapeutics.com/ ms.html), has passed a Phase I trial in patients with multiple sclerosis (MS) and is set to enter the next development stage.
Merck&Co., Inc. (Whitehouse Station, NJ, www.merck.com) has exercised an option for the exclusive use of the PER.C6 technology, owned by Crucell N.V. (Leiden, The Netherlands, www.crucell.com), and an option for access to Crucell's AdVac vaccine technology in two infectious disease areas.
On August 31, 2007, the US Food and Drug Administration (FDA) approved Somatuline depot (lanreotide) injection 60, 90, and 120 mg for marketing in the United States.
The center of gravity for the pharmaceutical market is shifting to the Asia-Pacific region from the US and Europe, according to an analysis published by PricewaterhouseCoopers (New York, NY, www.pwc.com).
GlaxoSmithKline (London, UK, www.gsk.com) has received another order from the US Department of Health and Human Services (HHS) for 22.5 million doses of bulk H5N1 antigen for the US national stockpile of pre-pandemic vaccines.
Sanofi Pasteur (Lyon, France, www.sanofipasteur.com), the vaccine arm of Paris-based Sanofi Aventis, recently completed construction of its new influenza vaccine manufacturing facility.
The US Food and Drug Administration's Nanotechnology Task Force (www.fda.gov/nanotechnology/ nano_tf.html) has released a report recommending the agency develop guidelines and take other steps to address the benefits and risks of products, including drugs and medical technology, that use nanotechnology.
GeoVax Labs, Inc. (Atlanta, GA, www.geovax.com), has announced an early start of two new acquired immunodeficiency syndrome (AIDS) vaccine clinical (human) trials.
Steven B. Engle has been appointed president, CEO, and director of Xoma Ltd., (Berkeley, CA, www.xoma.com).
Acambis (Cambridge, UK, www.acambis.com) and Bavarian Nordic (Kvistg?rd, Denmark, www.bavarian-nordic.com) have reached a global settlement ending the legal disputes between the two companies on matters relating to smallpox vaccines based on the modified vaccinia ankara (MVA) virus.
The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.
Genzyme Corp. (Cambridge, MA, www.genzyme.com) and the Oswaldo Cruz Foundation (FIOCRUZ, www.fiocruz.br) have announced plans to collaborate on research into new drugs focusing on neglected diseases.
Biotech giant Amgen (Thousand Oaks, CA, www.amgen.com) will shrink its workforce by 12–14 %, or approximately 2,200–2,600 employees, as part of its strategy to save more than $1 billion next year.
Lonza (Basel, Switzerland, www.lonza.com) purchased Zyentia's (Cambridge, UK, www.zyentia.com) Aggresolve technology, a comprehensive in silico protein analysis platform that can be applied to problem solving of protein aggregation, for an undisclosed sum.
New Brunswick Scientific (www.nbsc.com) has incorporated Allen Bradley PLC controls into its BioFlo Pro fermentors and bioreactors for system regulation, as well as easy exchange of data with auxiliary bioprocessing systems.
SemBioSys Genetics, Inc. (Calgary, Canada, www.sembiosys.com) announced that it has successfully produced commercial levels of apolipoprotein AI and its variant apolipoprotein AI(Milano), collectively referred to as Apo AI, in safflower seed lines.
Silence Therapeutics (London, England, www.silence-therapeutics.com) has appointed Jeffrey Scott Vick as Group CEO.
The August 7, 2007, issue of The Wall Street Journal Patent Scorecard ranks Wyeth (Madison, NJ, www.wyeth.com) first among 35 global pharmaceutical companies evaluated for patent-based intellectual property (IP).
The US Pharmacopeia (USP, Rockville, MD, www.usp.org) board of trustees has elected René H. Bravo, MD, as president of the USP convention for the remainder of its 2005–2010 cycle.
