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 Analytical system yields high-resolution images
The Cedex HiRes system from Roche Innovatis (Bielefeld, Germany) performs automated cell counts and analyses. It measures cell concentration, viability, cell diameter, compactness, specific growth rate, and aggregate ratio. The system stains and mixes cell samples automatically, and its multisampler can analyze 20 samples in sequence. The unit’s liquid-management and flowcell cleaning procedures are also automated. The instrument can be controlled remotely with software that can be integrated into an automated process easily, according to the company. The software ensures compliance with current good manufacturing practices.
The HiRes system incorporates moving microscope technology that scans the whole measurement chamber in one step. The technology has an identifiable-diameter range of 1–90 µm and provides a geometrical resolution of 0.8 µm.
In addition, the system stores measurements in a database, and measurements can be retrieved by parameters such as date, reactor number, or sample number. The product exports measurement data in various formats for use on other HiRes systems or workstations.
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EMC and Glemser
The FDA recently announced a June 2009 implementation date for SPL
Release 4, the latest update to the Structured Product Labeling standard
for submission of labeling content.
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BioSante Pharmaceuticals (Lincolnshire, IL) and Cell Genesys (South San Francisco, CA), entered into a definitive merger agreement under which BioSante will acquire Cell Genesys for $38 million. The merged company will operate as BioSante Pharmaceuticals.
Eisai (Tokyo) opened a new European Knowledge Center in Hertfordshire, United Kingdom, after investing approximately EUR 117 million ($165 million) in the region to help develop new medicines for cancer, Alzheimer's disease, Parkinson's disease and epilepsy. The company's first European manufacturing facility will also be based at the center.
GlaxoSmithKline (London) and Chroma Therapeutics (Oxford, UK) signed a pact to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process. Chroma is eligible to receive a potential $1 billion in milestones, option fees, and royalties based on compounds arising from the collaboration.
Helsinn (Lugano, Switzerland), a pharmaceutical group announced changes to its manufacturing operations in Ireland and Switzerland. Helsinn invested more than EUR 13 million ($18 million) this year to build a center of excellence for research and development for oral solid dosage at one of its facilities near Dublin, Ireland. Recently, the Helsinn Chemicals Organization (Biasca, Switzerland) is planning to expand the development and manufacturing services in the Swiss Helsinn Advanced Synthesis site. The company’s reorganization plan includes the sale of the Helsinn Chemicals Ireland Ltd. plant in Dublin to Medinco C.F.M. Group (Milan, Italy), a chemical pharmaceutical company.
Mylan (Pittsburgh, PA) entered an agreement with Biocon (Bangalore, Karnataka, India), to collaborate on the development, manufacturing, supply, and commercialization of multiple follow-on biologic compounds. Mylan and Biocon will share development, capital, and other costs to bring products to market. Mylan will have commercialization rights in the US, Canada, Japan, Australia, New Zealand, and in the European Union. Mylan will have coexclusive commercialization rights with Biocon in all other markets around the world. Financial terms were not disclosed.
Optimata (Ramat Gan, Israel), a provider of predictive computerized tools, signed a collaboration agreement with Teva Pharmaceutical Industries (Tikva, Israel) focused on clinical development of drug candidates for solid tumor cancers. The agreement is intended to enable clinical development of drug candidates that have been discontinued by their originator pharmaceutical companies, using Optimata’s biosimulation technology known as the Optimata Virtual Patient. Optimata will receive upfront payments, development milestones, and royalty payments. In a separate agreement, Teva made an undisclosed equity investment in Optimata.
Sanofi-aventis (Paris) announced a new research and development (R&D) model that is designed to transform the company's R&D and increase innovation. Sanofi-aventis will change the way it groups researchers and will emphasize recruiting and training. The company also announced this week that it appointed Christian Lajoux as president for sanofi-aventis in France. Lajoux is a member of the group management committee, and reports to Hanspeter Spek, executive vice-president of sanofi-aventis.
The contract research and manufacturing organization Syntagon (Södertälje, Sweden) will open a new office in Shanghai focused on providing clinical trial materials. The Shanghai offices will complement the company’s existing operations in Södertälje, Sweden, and Riga, Latvia.
Wyeth Pharmaceuticals, a division of Wyeth (Madison, NJ) and Catalyst Biosciences (South San Francisco, CA) will collaborate on development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions. Total payments under the collaboration, including an upfront payment of $21 million, research funding and milestone payments, could exceed $500 million, exclusive of royalty payments.
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The US Food and Drug Administration released Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.. The guidance document informs manufacturers of procedures for annual reviewing and updating of susceptibility test information in antibacterial drug product labeling.
The European Medicines Agency issued a guideline on genomic biomarkers,Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions.The guidance covers the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to drug response and reviews the five sections of a submission that should be included: regional administrative information, summaries, quality, nonclinical study reports, and clinical trial reports.
FDA said in the July 1, 2009 Federal Register, it is seeking public input on the implementation of its authority over tobacco products. The President signed the Family Family Smoking Prevention and Tobacco Control Act on June 22, 2009, allowing FDA to regulate tobacco products. Public comments can be made at http://www.regulations.gov and are due Sept. 29, 2009. More information about the legislation can be found on FDA’s website.
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Adeona Pharmaceuticals (Ann Arbor, MI), a specialty pharmaceutical company focused on subclinical zinc deficiency and chronic copper toxicity in the mature adult population, appointed Max Lyon CEO and president. Lyon has led six medical diagnostic and therapeutic companies, five of which he cofounded, including Confirma (Bellevue, WA) and CG Therapeutics (Seattle, WA).
Catalent Pharma Solutions (Somerset, NJ) appointed Sharon Johnson senior vice-president of quality and regulatory affairs, effective August 2009. Johnson will work at the company’s headquarters in Somerset, New Jersey. Ed Thiele, the current holder of the title, plans to retire in early 2010.
Danisco (Copenhagen, Denmark), a provider of food ingredients, enzymes, and biobased solutions, appointed Jeffrey Hogue vice-president of corporate sustainable development. Hogue brings 16 years of experience in sustainability and social responsibility from both Genencor, a Danisco division, and from other companies. Hogue replaces Søren Vogelsang, who retired.
Horizon Therapeutics (Northbrook, IL), a biopharmaceutical company, appointed Jeffrey W. Sherman executive vice-president and chief medical officer. Sherman joins Horizon from IDM Pharma (Irvine, CA), which was recently purchased by Takeda Pharmaceuticals (Tokyo).
Michael Reitermann was appointed CEO of Siemens Healthcare's (Malvern, PA) US organization, effective July 1, 2009. Reitermann will lead the marketing, sales, and service functions for Siemens Healthcare in the US, including the medical imaging, therapy, and healthcare information technology businesses. Reitermann succeeds Heinrich Kolem, who will assume the role of global head of Siemens Healthcare's angiography, fluoroscopy and X-ray business unit, based in Forchheim, Germany.
Sundia MediTech (Shanghai), a pharmaceutical and biotech research and development outsourcing company, appointed Tong Xu vice-president of process chemistry services. Xu previously worked at La Jolla Pharmaceutical (San Diego, CA), a biotechnology company, for 12 years, receiving promotions from his initial position of research scientist to associate director of process development.
TapImmune (Bellevue, WA), a biotechnology company, appointed Glynn Wilson executive chairman as part of an overall corporate restructuring plan. Wilson, who succeeds Alan Lindsay, will lead efforts to round out a new board of directors, management team, and technical and clinical advisory groups. Also associated with the restructuring, Pat McGowan resigned as CFO and board member. Denis Corin will vacate his position as CEO, retain his role of president, and assume a seat on the board.
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