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  Pharmaceutical Technology Europe E-Alert
 
11 November 2011

IN THIS ISSUE
Genentech violations
GSK settlement
Amylin and Lilly
Ophthalmic medicines

 
FDA notes violations at Genentech plant
The FDA has sent Genentech a Form 483 that lists several violations at the company’s South San Francisco plant, including problems with investigations into batch failures, inappropriate equipment design and insufficient protection against contamination. More...
 
GSK settles US investigations with $3 billion
GlaxoSmithKline has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. More...
 
Lilly and Amylin terminate diabetes alliance
Eli Lilly and Amylin Pharmaceuticals have mutually agreed to end a 10-year alliance relating to the diabetes medication exenatide. More...
 
EMA eyes ophthalmic medicines
Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, the European Medicines Agency has recently, and for the first time, brought together eye-disease experts from Europe, Asia, Japan and the US for a two-day workshop. More...
 
SOCMA lends support for measures addressing nontariff barriers
The Society of Chemical Manufacturers and Affiliates (SOCMA) has issued a statement to support a recently introduced bill intended to help the US federal government deal with market-access barriers more effectively. More...
 
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Latest blog posts
Accelerated approvals could raise risks for patients
Sanofi could be top by 2012
DHHS weights in on drug shortages
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Latest articles
Under continuous consideration
Applying universal anticounterfeiting technologies
Focus on standardisation, quality by design and regulatory GMP
More articles

Upcoming events
Downstream Bioprocessing & Single-use Systems Asia 2011 (1 December | Singapore)
FT Global Pharmaceutical and Biotechnology Conference (5–6 December | UK)
Serialization 2/0 - Getting Prepared for the Future of Pharma Supply Chain Security (13 December | Webinar)
More events

Product/Service Profiles
Oxoid

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.
Read More

 
Rapid Micro Biosystems

The Growth Direct™ System is purpose built for microbial quality control in pharmaceutical manufacturing, detecting contamination earlier and automating the analysis of growing colonies. The device is non-destructive and easy to validate. Read more


Event profiles

Cool Chain Logistics Europe 2012
30th January – 1st February
Basel, Switzerland
Over the past 11 years, CCLE has become the stomping ground for temperature control logistics and QA professionals in Europe to shape ideas for the future. Read more


 
Survey
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?
Increase 60%
 
Decrease 12%
     
Stay the same 28%

This week we would like to know...

What is driving manufacturers to reformulate or reinvent currently marketed solid dose pharmaceutical products?

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