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PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges
November 2, 2011–November 4, 2011
Rockville, Maryland
The Pharma Congress
November 2, 2011–November 4, 2011
Washington, DC
Cleanroom Microbiology for the Non-Microbiologist
November 7, 2011–November 8, 2011
King-of-Prussia, Pennsylvania
Quality Risk Management in Clinical Drug Development Conference
November 10, 2011–November 11, 2011
Berlin, Germany
4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California

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Abbott to Split into Medical-Products and Pharmaceuticals Companies
Abbott has unveiled a plan to separate into two publicly traded companies, one focusing on diversified medical products and the other on research-based pharmaceuticals. 
EC Probes J&J and Novartis
The European Commission has launched an antitrust investigation to examine whether contracts between Johnson & Johnson and Novartis were designed to delay the market entry of generic versions of Fentanyl in the Netherlands. 
Merck, Sharpe, and Dohme Announces New Investments in Singapore
Merck, Sharpe, and Dohme (MSD) and Singapore’s Economic Development Board jointly announced plans for significant investments by MSD to improve its existing manufacturing facilities in Singapore, as well as for new manufacturing, marketing, and research activities. 
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Mixer performs under full-scale conditions
Silverson’s Verso In-Line laboratory mixer is equipped with a digital tachometer, integral programmable timer, and simultaneous amp reading, thus allowing the user to monitor power draw and mixer speed over time throughout the mixing process. It operates at variable speeds as high as 8000 rpm. The unit incorporates single or multistage interchangeable workheads and stator screens.
The mixer has a 1-hp drive unit and a self-pumping flow rate of as much as 6.5 gal/min. Its instrumentation is augmented by the Silverson DataLogger program, which allows the user to plot information in a graph and archive readings or integrate them into databases. The Verso is a sanitary mixer designed for clean-in-place capabilities. The unit incorporates the design features of larger mixers in Silverson’s UHS range.
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The CDMO Almac has announced the expansion of its manufacturing capacity to over 30 m3 (1060 ft3) at its European Headquarters in Craigavon, United Kingdom. The upgraded facility will include reactor vessels with cleanroom product isolation and drying equipment to allow highly potent API manufacturing up to 600 kg (1320 lbs) of batch size.
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Boehringer Ingelheim has awarded the CDMO Patheon two projects with a combined revenue of more than $18 million over a three-year period. The projects are both fixed-dose combination drugs in development for the treatment of Type II diabetes.
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Colorcon and BASF have formed a collaboration for the development of film-coating systems using Kollicoat Smartseal 30 D, and a new Colorcon preformulated additive. Colorcon has developed a preformulated additive system for use with Kollicoat Smartseal 30 D which enables efficient preparation and application of this polymer in taste-masking applications. The preformulated additive lowers the number of materials to be dispensed by 50% and reduces the preparation time by almost 40%.
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Single-us disposable filling needles are now available for Bosch and TL fillers. Disposable needles eliminate cleaning, and cross contamination concerns and reduce issues with bent needles. Available presterilized or autoclave ready. Needles are available
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Ferring Pharmaceuticals, a biopharmaceutical company, has completed the purchase of the specialty pharmaceutical company Cytokine PharmaSciences and its United Kingdom subsidiary Controlled Therapeutics, a biopharmaceutical company with a particular focus in obstetrics.
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Merck KGaA plans to return all rights for safinamide, a treatment for Parkinson’s Disease, to Newron Pharmaceuticals. Merck had acquired exclusive worldwide rights to develop, manufacture, and commercialize safinamide pursuant to its agreement with Newron, which was signed in 2006. The termination of this agreement will become effective in April 2012 and will result in approximately EUR 40 million ($55.8 million) of additional costs for the Merck Serono division in the fourth quarter of 2011. These costs will be excluded from both the division’s and the Merck Group’s fourth quarter underlying core operating result.
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The CDMO Norwich Pharmaceuticals has increased its pilot-scale production capabilities, including a facility expansion that doubles its current capacity for pilot-scale development and manufacturing. The additions at the Norwich, New York, facility include equipment, surface area, and staff.
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Silverson Ultra Sanitary In-Line high shear mixers are designed for facilities where clean-in-place (CIP), as well as sterilize-in-place (SIP) is required. Silverson is the only mixer manufacturer of its kind offering mixers certified to meet both 3-A Third Party Verification sanitary standards and the European Hygienic Engineering Design Group (EHEDG) standard considered the international benchmark for sanitation. Contact Silverson for a Free trial.
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Novartis has announced the reduction of approximately 2000 jobs. The company said 1100 jobs will be cut in Switzerland, and an additional 900 jobs cut in the United States. Novartis plans to add approximately 700 new positions in low-cost countries such as India and China.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Bend Research, a CDMO, has appointed John McLeod as chief financial officer. McLeod was formerly director of business development with Mt. Bachelor Ski Resort for six years.
Sanofi has appointed David Meeker as CEO of its subsidiary Genzyme, effective Nov. 1, 2011. He will report to Sanofi CEO Christopher A. Viehbacher and will join the group management committee. Viehbacher will retain the position of chairman of Genzyme.
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Small-Molecule API Outsourcing
In your company for 2012, how do you anticipate the level of outsourcing for small-molecule API development and manufacturing will change compared with 2011?
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