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  Pharmaceutical Technology Europe E-Alert
 
25 November 2011

IN THIS ISSUE
FDA Avastin ruling
Antimicrobial action plan
Ben Venue
Counterfeiting penalties

 
FDA removes Avastin breast cancer indication
The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use. More...
 
European action against antimicrobial resistance
The European Commission (EC) has unveiled a comprehensive action plan against antimicrobial resistance that includes provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorizations. More...
 
Ben Venue suspends manufacturing at Bedford plant
Ben Venue Laboratories has voluntarily and temporarily suspended the manufacture and distribution of products made at its Bedford (Ohio, US) facility as an internal review of documentation at the site indicated that routine preventive maintenance and requalification of manufacturing equipment was overdue. More...
 
US bill will stiffen penalties for drug counterfeiters
A bill that would increase penalties for those convicted of trafficking in counterfeit drugs has been introduced in the US House of Representatives. More...
 
SOCMA Raises Concern Over Proposed Legislation for TSCA Reform
The Society of Chemical Manufacturers and Affiliates (SOCMA) has issued a statement supporting the evaluation of national chemical-control laws, but specifically opposing the US Safe Chemicals Act, which was introduced earlier this year. More...
 
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Latest blog posts
Could Ben Venue's manufacturing suspension have been avoided?
FDA revokes breast cancer indication for Avastin
Keeping it clean
More blog posts

PTE Digital
Applying universal anticounterfeiting solutions
Frontline defence
Optical character recognition and code verification
More articles

Upcoming events
FT Global Pharmaceutical and Biotechnology Conference (5–6 December | UK)
West Coast Forum on Clinical Supply Chain Management (6–7 December | USA)
Serialization 2/0 - Getting Prepared for the Future of Pharma Supply Chain Security (13 December | Webinar)
More events

Product/Service Profiles
Oxoid

Harmonized Culture Media for MLT
Oxoid and Remel, the world leading microbiology brands of Thermo Fisher Scientific, have introduced a complete portfolio of culture media for the microbiological examination of non sterile pharmaceutical products, as recommended in the Harmonized Microbial Limit Tests chapters in the Ph. Eur, USP and JP (current editions). Read more...


Future Podcasts

Vetter's Chicago Facility Fully Operational
In 2010, Vetter brought you up to date on the company’s plans to expand its Vetter Development Service operations by opening its first manufacturing site outside of Germany. Just recently, Vetter announced that the site, located in Chicago at the Illinois Science + Technology Park in Skokie, is fully operational. Read more

 
Survey
What is driving manufacturers to reformulate or reinvent currently marketed solid dose pharmaceutical products?
Need to renew patents 49%
 
Availability of new excipients 11%
     
Opportunity to improve efficacy and patient compliance 40%

This week we would like to know...

Do you support a generic-drug user fee for industry?

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