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FDA strategy to improve regulatory science
In an effort to “keep pace with and utilize…new scientific advances” and to promote public health, the FDA has released a strategic plan to advance regulatory science. More... |
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GSK takes £1.25-million stake in new spin out
GlaxoSmithKline has taken a stake worth £1.25 million in its biotech spin out company, Autifony Therapeutics, which aims to develop new treatments for hearing disorders. More... |
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£800 million pledged for translational research in UK
The UK government has set aside a record £800 million in funding for translational research to boost the development of medicines, treatments, and care for patients, particularly in the fields of cancer, diabetes and heart disease. More... |
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Catalent to acquire Aptuit's clinical trial supply business
To further enhance its position in the supply of clinical-trial materials, Catalent Pharma Solutions has agreed to acquire the clinical-trial-supplies business of Aptuit for $410 million on a cash and debt-fee basis.
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Drug shortages loom large in US
In 2010, the FDA recorded almost 180 drug shortages — triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics. More... |
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Join our community on LinkedIn
Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More... |
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| Product/Service Profiles |
| Oxoid |
Genetic Identification and Characterization in less than 8 Hours 
The DuPont Qualicon RiboPrinter® microbial characterization system provides the speed, accuracy and resolution needed to identify bacteria and compare them at the strain level characterization, all in less than 8 hours. This automated system is available in Europe, Canada and Australia alongside Oxoid products.  Read more |
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| Sterilin |
 Non-pyrogenic polystyrene containers
Sterilin non-pyrogenic polystyrene containers are certified endotoxin-free to levels below 0.01EU/ml, making them ideal for use in the pharmaceutical industry for the storage of samples, formulation work, sterility testing and endotoxin testing. Sterilized by gamma irradiation, they are available in a wide range of volumes.  Read more
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| Veltek |
Veltek debuts new sterile clean room wipes, 
including the industry’s first sodium hypochlorite and hydrogen peroxide clean room wipes.
Veltek Associates, Inc., recently debuted four new sterile clean room wipes, including the HYPO-CHLOR® Saturated Sodium Hypochlorite Wipe and the STERI-PEROX®. Saturated Hydrogen Peroxide Wipe.
 Read more |
| Live Webcast |
Preventing Costly Out-of-Specification Investigations
Tues, 20 Sept 2011, 11:00 EST, 4:00 PM BST
Join Dr. Charles Ray, former Associate Director of Analytical R&D at Bristol-Myers Squibb Co. and he will show you how to tackle 50% of the errors that cause Out-of-Specification results by streamlining sample/standards preparation.  More information... |
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| As it creates a plan to implement the US biosimilar pathway, should FDA borrow from EMA's pathway? |
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Borrow heavily from EMA's pathway program? |
45% |
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Borrow lightly from EMA's pathway program? |
26% |
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Create entirely its own pathway program? |
26% |
This week we would like to know...
What is your company's main driver for outsourcing biologics?
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