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  Pharmaceutical Technology Europe E-Alert
 
11 February 2011

IN THIS ISSUE
Innovation failure
Stem cell guidance
Indian biosimilars
US patent reform

 
Regulations causing innovation failure
According to the UK’s Economic and Social Research Council (ESRC), the closure of Pfizer’s UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals. More...
 
EMA speaks out on stem cell products
The EMA has released a reflection paper that advises manufacturers on quality control issues regarding the use of stem cells in drug development. More...
 
India to become a biosimilar powerhouse
India is set to become a “biosimilar powerhouse”, with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts Datamonitor. More...
 
US considers patent reform
The US Senate has scheduled the Patent Reform Act of 2011 for debate, which would enhance patent quality and the efficiency, objectivity, predictability, and transparency of the patent system. More...
 
USP moves drug quality pilot program into Sub-Saharan Africa
The United States Pharmacopeial Convention (SP) has launched a 12-month pilot Technical Assistance Program to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines. More...
 
SOCMA issues statement on US TSCA reform
The Society of Chemical Manufacturers and Affiliates (SOCMA) has provided support for a bipartisan review of the US Toxic Substances Control Act (TSCA), which the organization believes is a complex issue that deserves close scrutiny. More...
 
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...

Latest blog posts
Informex 2011: tracking the fortunes of chemically synthesized APIs
Lethal injections and foreign inspections
Pfizer site closure “Shocking Wake-Up Call” for UK
More blog posts

Excipients articles
An update on the EU's plans for excipient regulation
Is there a need for stringent regulations for excipients?
Using excipients in powder formulations
More articles

Upcoming events
Pharmapack (23–24 February | France)
Personalised Medicine — the evolving regulatory landscape (2 March | UK)
Pittcon 2011 (13–18 March | UK)
More events

Product Profiles
Oxoid

QC Organisms for performance qualification of culture media
Quanti-Cult Plus™ quality control micro-organisms are ideal for use in pharmaceutical applications such as growth promotion testing and method validation. They are convenient to use with each aliquot guaranteed to deliver <100 CFU and only 3 passages from the ATCC® strain. Once reconstituted they are stable for up to 8 hours at 2-8C. Read more...

 
Equipnet

Complete Plant Closure: High-End Pharma/API Equipment Available in UK
This project includes 133 listings for tanks, reactors, isolation equipment, boilers, air compressors, thermal oxidizers, and more, constructed from stainless steel, glass, and hastelloy. Read more...


Event Profiles
 
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BioEurope Spring 2011
Milano Convention Centre (MIC)

March 14–16 2011
Milan, Italy

BIO-Europe Spring is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe, and continues the tradition of providing life science companies with high caliber partnering opportunities. Read more...

 
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Chemspec Europe 2011
15-16 June 2011

Hall 1, PALEXPO
Geneva, Switzerland

Europe’s dedicated fine and speciality chemicals event.
With a focused range of exhibits, easily identified feature areas, free-to-attend conferences and seminars in a relaxed atmosphere with quality ‘face-time’, there’s no more direct or attractive place for taking orders in just two days.
Read more...

 

 



Survey
FDA recently was granted the authority to issue recalls for food products. Should the agency have this power for pharmaceuticals as well?
Yes 86%
 
No 14%

This week we would like to know...

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