News

AstraZeneca PLC (London, UK, www.astrazeneca.com) has announced the resignation of its CFO Jon Symonds, at the end of July. Symonds joined Zeneca in 1997 as CFO after 17 years at KPMG.

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use.

Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India's first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.

The BioWelder and BioSealer from Sartorius (www.sartorius.com) are suitable for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes.

Kythera Biopharmaceuticals, Inc. (Calabasas, CA, www.kytherabiopharma.com), has appointed Patricia Walker, MD, PhD, as chief medical officer and vice president of clinical development and regulatory affairs.

The FDA has approved Humate-P (antihemophilic Factor/von Willebrand Factor Complex), CSL Behring's (Marburg, Germany, www.cslbehring.com) factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD).

Serum Institute of India Ltd. (SII Ltd., Pune, India, www.seruminstitute.com) has developed a vaccine against Hib (Haemophilus influenza type b) and obtained a license from the Indian Government for its production.

Dutch biotechnology company Crucell N.V. (Leiden, the Netherlands, www.crucell.com), the Aeras Global TB Vaccine Foundation (Rockville, MD, www.aeras.org) and the South African Tuberculosis Vaccine Initiative (SATVI, Cape Town, South Africa, www.satvi.uct.ac.za) at the University of Cape Town, recently announced the launch of a new Phase 1 clinical trial of the AdVac-based tuberculosis vaccine, six months after launching a similar study in the US.

Dutch biotechnology company Crucell N.V. (Leiden, the Netherlands, www.crucell.com) and Novartis Vaccines and Diagnostics, Inc. (Basel, Switzerland, www.novartis.com), have extended a nonexclusive research license agreement for PER.C6.

Although difficult to conceive, the 21st century may see the boundaries of biological knowledge completely defined.

Acambis plc (Cambridge, UK, www.acambis.com) has announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration has voted unanimously that Acambis' ACAM2000 is both safe and efficacious.

The Bio Affinity Company BAC BV (Naarden, the Netherlands, www.bac.nl) has entered into an agreement with Sanofi Pasteur (Lyon, France, www.sanofipasteur.com), the vaccines arm of the Sanofi-Aventis Group, for the use of BAC's CaptureSelect customized affinity ligands for process-scale purification of some of its vaccine products.

Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.

Viragen, Inc. (Plantation, FL, www.viragen.com), and its collaborative partners in the field of avian transgenics-Roslin Institute (Scotland, UK, www.roslin.ac.uk) and (Oxford, UK, www.oxfordbiomedica.co.uk)-have announced a significant breakthrough in the development of the OVA system, an avian transgenic protein expression technology.

Kenneth J. Martin, Wyeth's (Madison, NJ, www.wyeth.com) chief financial officer and vice chairman, has announced plans to leave the company at the end of June.

Millipore Corporation's disposable mixer is designed to help companies mix pharmaceutical ingredients and prepare cell culture media.

Governor Deval Patrick of Massachusetts has proposed a plan for committing $1-billion over the next decade to life-sciences research, including the creation of a stem-cell bank, in an effort to make the state a global leader in biotechnology.

Focetria, a new human vaccine from Novartis (Basel, Switzerland, www.novartis.com) designed for use following the declaration of an influenza pandemic, has received European Union (EU) approval in all 27 member states as well as Iceland and Norway.

James M. Cornelius, who has served as interim chief executive for the past eight months, has been elected chief executive officer of Bristol-Myers Squibb Company (New York, NY, www.bms.com) with a term through the date of the company's annual meeting of stockholders in 2009.

Following the US Senate approval of the FDA Revitalization Act (FDARA, S.1082) in May, the debate over drug safety and the reauthorization of the Prescription Drug User Fee Act (PDUFA) now moves to the House.

AstraZeneca (London, UK, www.astrazeneca.com) has entered into a definitive agreement to acquire MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), in an all-cash transaction.

Major pharmaceutical and biotechnology companies have joined forces under the auspices of the Society for Biological Engineering (SBE, New York, NY, www.aiche.org/SBE) to make use of cell line research that is expected to increase the efficiencies of drug development.

Roche (Basel, Switzerland, www.roche.com) has acquired Therapeutic Human Polyclonals, Inc. (THP, Mountain View, CA, www.polyclonals.com), a privately-owned biotechnology company based in California and Germany.

In March, the US Food and Drug Administration released a new draft guidance, along with its guidance agenda for the year.

DelSite Biotechnologies, Inc. (Irving, TX, www.delsite.com), a wholly-owned subsidiary of Carrington Laboratories, Inc. (Irving, TX, www.carringtonlabs.com), has entered into a non-exclusive technology evaluation agreement with Nastech Pharmaceutical Company, Inc. (Bothell, DC, www.nastech.com), for the purpose of evaluating DelSite's GelSite polymer for enhancing the intranasal delivery of peptide and protein therapeutics.

The FDA's (Rockville, MD, www.fda.gov) first approval in the United States of a vaccine for humans against the H5N1 influenza virus marks an important step forward in protecting the public against a pandemic influenza outbreak.

Intranasal Therapeutics, Inc. (ITI, Montvale, NJ, www.intranasal.com), has appointed Peter F. Young as president and chief executive officer.

Neotropix, Inc. (Malvern, PA, www.neotropix.com), a biotechnology company dedicated to the development and commercialization of virus-based therapeutics for the treatment of cancer and other diseases, received a warning letter (http://www.fda.gov/foi/warning_letters/b6308d.pdf) on March 23, 2007, citing deviations from good laboratory practices (GLP) regulations governing the proper conduct of nonclinical studies as published under 21 CFR Part 58.