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Novel Immunotherapeutics Summit
January 30, 2012—January 31, 2012
San Diego, CA, USA
Cool Chain Logistics Europe 2012
January 30, 2012—February 1, 2012
Basil, Switzerland
Computer System Validation - Reduce Costs and Avoid 483s
February 2, 2012—February 3, 2012
Scottsdale, AZ, USA
Pharmaceutical Parallel Trade
February 6, 2012—February 7, 2012
London, United Kingdom
Global ManuCHEM Strategies 2012
February 13, 2012—February 14, 2012
Berlin, Germany 
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European Outsourcing Revenue to Grow by 50%
According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011’s revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion. 
Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply
Sanofi’s subsidiary Genzyme has received FDA’s approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry’s disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.
EMA Releases Pharmacogenomics Concept Paper
The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.
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 Particle-size analyzer facilitates dry-powder measurement
Malvern Instruments’s Mastersizer 3000 particle-size analyzer is designed to extend dry measurements to a wide range of sample types. It provides a 10-KHz data-acquisition rate, and all parameters for dry-powder measurement (i.e., sample feed rate, dispersion pressure, and system cleaning) are controlled through the software by its SOP interface. Its real-time feedback capability helps streamline method development and routine measurement.
The analyzer’s Aero S dry-powder disperser enables users to measure materials from 0.01 to 3500 µm. It disperses dry samples by accelerating particles through a venturi mechanism, using compressed air at a user-defined pressure. The particles then pass through the Mastersizer 3000’s laser for measurement and are collected using a vacuum source. The sample feed rate through the Aero S is closely controlled using a vibrating feeder, which maintains a suitable sample concentration for laser measurement. It is fitted with an interchangeable sample tray that can be configured to ensure the measurement of enough material to quantify the entire size distribution reproducibly. |
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Alnylam Pharmaceuticals, a company specializing in RNA interference (RNAi) drug development has announced plans to implement a corporate restructuring, including an approximate 33% reduction in its workforce, in order to align resources with its clinical-development program. The company is focusing on its Alnylam 5x15 RNAi therapeutic product strategy, which is a company strategy launched in January 2011 to develop and commercialize novel RNAi therapeutics. Two lead programs are ALN-TTR, to treat transthyretin-mediated amyloidosis, and ALN-APC to treat hemophilia. Read More
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FDA has issued a complete response letter to AstraZeneca and Bristol-Myers Squibb regarding the companies' new drug application for the investigational compound dapagliflozin for treating Type II diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the risk–benefit profile for dapagliflozin. This includes clinical-trial data from ongoing studies and may require information from new clinical trials. Read More
The International Society of Pharmaceutical Engineers (ISPE) and Interphex have recognized the 2012 recipients of the Facility of the Year Awards, an annual recognition of innovation and accomplishments in facility design, construction and operation. Awards were given in the following categories: Equipment Innovation: Rentschler Biotechnologie for its REX III manufacturing facility in Laupheim, Germany; Sustainability: Chiesi Farmaceutici for its R&D center in Parma, Italy; Project Execution: Eisai Pharmatechnology & Manufacturing for its integrated R&D and manufacturing complex in Visakhapatnam, India; Facility Integration: Merck & Co. for its vaccine bulk manufacturing facility in Durham, North Carolina; Operational Excellence: Roche Diagnostics for its expansion of its therapeutic proteins project; and Special Recognition for Novel Collaboration: National Institute for Bioprocessing Research and Training (NIBRT) for its medium-scale bioprocessing plant in Dublin, Ireland. For additional details of the project work, Read More
Merck & Co. has agreed to resolve all claims related to Vioxx (rofecoxib) in Canada. The agreement was signed by Merck and plaintiffs’ representatives and is pending approval by courts in Canada’s provinces. If the agreement is approved and specified conditions are met, Merck will pay a total amount of at least C$21.8 million ($21.7 million) but not more than C$36.9 million ($36.7 million). This would resolve all Vioxx certified class actions, putative class actions, other litigation and claims related to Vioxx in Canada. The amount to be funded for Vioxx users in Canada will be between C$11.3 million ($11.2 million) and C$26.4 million ($26.2 million) and will be determined by the final number of eligible claimants. Read More
In other news:
Abbott's Starlims laboratory information management system technology will be installed in FDA testing laboratories.
Almac has successfully completed MHRA inspections at its facilities in Craigavon (headquarters), Northern Ireland, and Elvingston, Scotland.
Genzyme and Veracyte have agreed to copromote Veracyte's Afirma thyroid fine-needle aspiration analysis for thyroid patients.
Congresswoman Mary Bono Mack (R-CA) has written a letter criticizing FDA for lack of oversight of Novartis's Novartis's consumer-healthcare manufacturing facility in Lincoln, Nebraska.
Novo Nordisk has established a Type I diabetes R&D center in Seattle, Washington.
Patheon adds soft-gel capsule capabilities through new partnership with Procaps.
Pharmaceutics International has begun construction of a new aseptic fill–finish manufacturing facility.
Roche has agreed to acquire Illumina, a provider of DNA sequencing systems, for $5.7 billion, as part of genetic testing, diagnostics, and drug-development efforts.
Sartorius Stedim Biotech and Refine Technology have announced an agreement to develop a high-density cell-cultivation platform.
Sartorius Stedim Biotech and G-Con partner to provide advanced and flexible biopharmaceutical production platforms.
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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API Manufacturing
What is the most important change that has influenced chemical API manufacturing during the past 10 years?
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