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FDA Unveils PREDICT System for Import Inspections
Margaret Hamburg, FDA commissioner, unveiled a new program to improve the efficiency of import inspections. 
Pfizer, Bayer, and BMS Advance Personalized-Medicine Products
Personalized medicine is still an emerging field for the pharmaceutical industry, but several large companies recently reported developments in this area.
GSK Plans Further Restructuring in R&D
GlaxoSmithKline Chief Executive Andrew Witty outlined the company’s strategic priorities for 2010, which include further diversification into emerging markets, consumer healthcare, and vaccines.
EMA Statistics Reveal Generic Dominance
European Medicines Agency statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009.
GlaxoSmithKline Creates New Unit for Rare Diseases R&D
GSK launched a stand-alone unit that will specialize in the research, development, and commercialization of medicines for rare diseases. |
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analytica, March 23 – 26, 2010 in Munich, Germany
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at  www.analytica.de/en
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 Lifter accommodates various production needs
The Wash Down Series ergonomic lifter from RonI (Charlotte, NC) is designed for pharmaceutical cleanroom applications. The lifter’s base is made of electropolished stainless steel, and its lift mast profile and lift carriage are hard anodized aluminum. This construction allows the lifter to withstand washdown using cleaning solutions and hose or power washing. The lifter safely handles cytotoxic products, and operators can clean it for other cleanroom or noncleanroom applications as required.
A slip clutch eliminates kickback on the lifter’s downward stroke, thus preventing damage to products and equipment. A stainless steel ball screw lifts and lowers loads. Users can attach a series of end-effectors to the lifter and retrofit the machine with various lift masts. These features enable the machine to perform various load-handling applications and meet many production needs. The lifter can handle totes, drums, carboys, and rolls. |
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AB SCIEX (Foster City, CA), a designer and manufacturer of mass spectrometers, reorganized as a new company dedicated to life-science analytical technologies. The company said its new operating structure will increase speed to market and expand service and support to the scientific community.
Generic-drug manufacturer Actavis (Hafnarfjordur Iceland) will expand its manufacturing site in Hafnarfjordur, Iceland. The expansion will increase the site’s capacity to approximately 1.5 billion tablets per year and create 50 new jobs. Production is expected to start at the new facility by the end of 2010.
AnaptysBio (San Diego, CA), a privately held therapeutic-antibody platform and product company, will collaborate with Merck & Co. (Whitehouse Station NJ) to develop antibody therapeutics to an undisclosed disease target. AnaptysBio will generate antibodies to a specified disease target using its somatic hypermutation technology platform. Merck will receive worldwide rights to develop and commercialize antibodies optimized by AnaptysBio. which received an upfront sum and will receive milestone payments and royalties associated with products from the collaboration.
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TOC Wet Chemical Analyzer Ensures Ultra-pure Water
Utilizing the exclusive Heated-UV-Persulfate oxidation method to provide rapid, efficient breakdown of hard-to-oxidize compounds, Shimadzu’s TOC-VW ensures ultra-pure water for pharmaceutical applications. Reduce analysis time with such features as random-access autosampler control and a high-sensitivity NDIR detector that eliminates false peaks. In addition, reduce the cost of ownership with low-cost consumables.  Learn more. |
Gorbec Pharmaceutical Services (Durham, NC), a contract developer and manufacturer of prescription pharmaceuticals, will open a good-manufacturing-practice compliant analytical laboratory in Yantai, China. The facility, scheduled to open in May 2010, is expected to improve Gorbec’s efficiencies and reduce costs.
The biopharmaceutical company International Stem Cell (Oceanside, CA) announced that its new-cell production facility passed its final building inspection. The company will develop and manufacture clinical-grade stem-cell products at the facility, which is located close to fertility clinics that provide donated human eggs and also near prominent research institutions.
Clinical-stage biotechnology company Novavax (Rockville, MD) ended collaboration negotiations with ROVI Pharmaceuticals (Madrid) to develop Novavax’s virus-like-particle-based vaccines against influenza. Novavax is free to seek a new partner for its pandemic and seasonal-influenza vaccine.
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Why clean the cleanroom? We are disinfecting it!
This is the most popular question we hear. Owners and operators often assume that normal cleaning procedures are optional or even unnecessary because they are disinfecting.
The accumulation of dust and particles in cleanrooms offer protection for microbes from disinfectants. Much like an umbrella does for us in the rain. Surviving microbes have the potential to destroy the product and affect batch yields.
Cleaning in addition to disinfecting is not an option, but should be considered in conjunction with disinfecting to ensure product safety. Clean products directly relate to higher profits.
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more...
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Research-sciences company Peakdale Molecular (Chapel-en-le-Frith, UK) will supply synthetic-chemistry services to Pfizer (New York) at the company's laboratories in Sandwich, UK. The collaboration will involve more than 50 synthetic chemists from Pfizer and 90 from Peakdale. The collaboration will provide on-site chemistry resources for Pfizer and resources for other companies in the vicinity.
Biopharmaceutical company Poniard Pharmaceuticals (South San Francisco, CA) announced a 57% cut in its workforce to reduce operating costs. The cuts were effective Feb. 5, 2010 and reduced the company’s total employees to 21. Poniard expects the cuts to produce $4 million in reduced-annualized operating expenses in 2010.
Roche (Basel) announced a strategic alliance with Singapore’s scientific and medical institutions to create a translational research hub in Singapore. Called the “Hub for Translational Medicine,” the research hub is designed to further understanding of how scientific advances from preclinical research can be transferred in practice to patients. It will employ about 30 scientists.
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Informex
What better way to learn what is needed as you plan your sales and marketing strategy than by speaking with the pharma decision makers on the other side of the table?
At Informex you’ll have that opportunity – join us February 16, 2010 for an interactive panel discussion with top executives from leading, global pharmaceutical giants.
This is an unprecedented opportunity that will focus on pressing issues such as outsourcing, restructuring and consolidation.  Register
Today
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sanofi-aventis (Paris) will enter the consumer healthcare market in China through an agreement with Minsheng Pharmaceutical Group (Hangzhou, China). The new venture will focus on vitamins and mineral supplements, which is China’s largest consumer healthcare segment, and sanofi-aventis will hold a majority equity stake.
Therapure Biopharma (Toronto) completed the commissioning and validation of its commercial-scale, pharmaceutical-grade, freeze dryer and now offers lyophilization for contract manufacturing of biopharmaceuticals. In other news, Therapure Biopharma signed a toll-manufacturing agreement with the biopharmaceutical company LFB Biomedicaments (France).
Thermo Fisher Scientific (Waltham, MA) agreed to acquire Finnzymes (Espoo, Finland), a provider of integrated tools for molecular-biology analysis, including reagents, instruments, consumables, and kits. Finnzymes, which has 90 employees and generated $20 million in revenues in 2009, provides comprehensive solutions for high-performance polymerase chain reaction (PCR), reverse transcription and real-time quantitative PCR.
The shareholders of biopharmaceutical company VaxGen (South San Francisco, CA) rejected a proposed merger with OXiGENE (South San Francisco, CA), a biopharmaceutical company focused on cancer and eye diseases. While more shareholders voted to approve the merger than to reject it, the number of approval votes fell short of the majority required to approve the merger.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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 Vetter Development Service Chicago
Peter Soelkner
Managing Director, Vetter Pharma International GmbH
Listen to this podcast recorded live from the show floor of AAPS 2009. Clinical development is key for new drugs. In order to minimize risks and take advantage of opportunities, you need comprehensive know-how and years of experience. Vetter, as a specialist in the aseptic filling of injection systems, will provide with its new facility the manufacturing of preclinical, Phase I and Phase II clinical batches in Chicago. We invite you to find out more about Vetter Development Services USA Inc.
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Genzyme (Cambridge, MA) appointed Scott Canute president of global manufacturing and corporate operations. Canute was formerly the manufacturing head at Eli Lilly (Indianapolis, IN).
GlaxoSmithKline (GSK, London) appointed Philippe Fauchet president of GSK Japan. Philippe will report to Marc Dunoyer, who was appointed chairman of GSK Japan. Philippe joined GSK from sanofi-aventis where he was senior vice-president, business development.
Poniard Pharmaceuticals (South San Francisco, CA) appointed Ronald A. Martell chief executive officer. He succeeds Jerry McMahon, who will remain non-executive chairman of the board. Michael S. Perry was named president and chief medical officer. |
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PAT: A New Dawn for Drug Product Quality |
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| Angie Drakulich and Patricia Van Arnum |
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A technical forum moderated by Angie Drakulich and Patricia Van Arnum.
Coming Soon: PharmTech's March cover story addresses fill-and-finish
technologies for parenterals.
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| DCAT Rolls Out Educational Programming |
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| Patricia Van Arnum |
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The rising importance of generic drugs, evolving requirements in the ever-more global supply chain, and supplier-management strategies in biologics manufacturing are key topics to be addressed during DCAT Week.
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CMO Market
What factor do you think will be most significant in 2010 for determining the health of the market for contract manufacturing of active pharmaceutical ingredients?
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View the poll archive. |
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