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The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing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.
A team of Wyeth (Madison, NJ, www.wyeth.com) scientists involved in the discovery, development, and manufacture of Prevnar-pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)-was awarded the 2005 National Medal of Technology by President George W. Bush at a White House ceremony in late July.
Roche Pharmaceuticals (Basel, Switzerland, www.roche.com) has named Severin Schwan, PhD, the current head of diagnostic division, new chief executive.
Genentech, Inc. (South San Francisco, CA, www.gene.com), has announced an agreement with Tercica, Inc. (South San Francisco, CA, www.tercica.com), for the development, manufacture, and commercialization of two products containing Genentech?s recombinant human growth hormone Nutropin AQ (somatropin, rDNA origin) and Tercica?s recombinant insulin-like growth factor-1 Increlex (mecasermin, rDNA origin) for the treatment of short stature, adult growth hormone deficiency (AGHD), and potentially other metabolic disorders.
The US Pharmacopeia (Rockville, MD, USP, www.usp.org) recently announced that the implementation period for its USP–NF general notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter <467> has been extended from July 1, 2007 to July 1, 2008.
Karen Daniels has joined Althea Technologies, Inc. (San Diego, CA, www.altheatech.com), as president of the company's bio-services division.
Acambis plc (Cambridge, UK, www.acambis.com) has initiated a Phase 1 clinical trial of its universal influenza vaccine candidate, ACAM-FLU-A.
The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System.
FDA has named Virginia Behr as the Center for Drug Evaluation and Research (CDER, www.fda.gov/cder/) ombudsman.
NanoMed Pharmaceuticals, Inc. (Kalamazoo, MI, www.nanomedpharm.com), has appointed Harry C. Ledebur, Jr., PhD, as the company's vice president of research and development and chief scientific officer.
Novartis Vaccines (Basel, Switzerland, www.novartisvaccines.com) plans to produce approximately 40 million doses of its Fluvirin vaccine for distribution in the US during the upcoming 2007–2008 influenza season-a 30% increase in supply from Novartis compared with the previous influenza season.
The Kobio pump from Bioengineering (www.bioengineering.ch) has three pneumatically actuated diaphragm valves arranged in a series.
Althea Technologies, Inc. (San Diego, CA, www.altheatech.com), has been contracted by GeoVax Labs, Inc. (Atlanta, GA, www.geovax.com), to manufacturer its HIV-1 DNA vaccine.
