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Acambis and Bavarian Settle Disputes
August 21st 2007Acambis (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.
FDA Highlights Responsibilities for Finished Biologics Manufacturers
August 21st 2007The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing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.
Lonza Acquires Zyentia’s Aggresolve Technology
August 21st 2007Lonza (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.
SemBioSys Produces Commercial Levels of Recombinant Apo AI Using Plants
August 21st 2007SemBioSys 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.
Wyeth Recognized for Prevnar Vaccine
August 21st 2007A 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.
Genentech Inks Pacts with Tercica and Abbott
July 24th 2007Genentech, 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.
USP Extends Time to Meet Residual Solvent Standards
July 24th 2007The 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.
Novartis to Boost US Flu Vaccine Supply, Gains Access to Intercell's Technology
July 24th 2007Novartis 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.
Roche Enters RNAi Therapeutics Race
July 24th 2007Roche (Basel, Switzerland, www.roche.com) and the biopharmaceutical company Alnylam Pharmaceuticals, Inc. (Cambridge, MA, www.alnylam.com), have entered into a major alliance in which Roche obtains a nonexclusive license to Alnylam's technology platform for developing RNAi (RNA interference) therapeutics.
Merck Serono's Pergoveris Approved in EU
July 24th 2007In late June, the European Commission granted marketing authorization for Merck Serono S.A.’s (Geneva, Switzerland, www.serono.com) Pergoveris, the first biologic intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.
Operations Excellence: Optimizing Efficiency
July 1st 2007In the April issue of BioPharm International, the article "BioPharmaceutical Operations Roadmap," provided a summary of the key industry gaps executives would like to close in the next 10 years. These goals came to my mind while I was attending Interphex this April in New York.