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  Pharmaceutical Technology Europe E-Alert
 
1 October 2010
IN THIS ISSUE
FDA clinical trial rule
Pharma must be transparent
Pfizer trial scrapped
EMA suspensions
FDA’s final rule on clinical trials
The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. More...
 
Pharma companies must be more transparent
Pharma companies must ensure that patients have access to “objective, unbiased information” about medicines, according to MEPs of the European Parliament’s Health Committee — this should be a patient right rather than an option for pharma companies. More...
 
Pfizer scraps cancer clinical trial
Pfizer has discontinued a Phase III trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer following disappointing results. More...
 
Suspensions and safety reviews from the EMA
It’s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures. More...
 
Amgen recalls products for glass flakes
Amgen has issued a voluntary recall of certain lots of Epogen and Procrit (Epoetin alfa) vials that may contain thin glass flakes. 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
Avandia banned in Europe
Eli Lilly CEO calls for regional innovation clusters
Sproxil’s Mobile Phone Technology Tracks Medical And Food Donations, Prevents Diversion
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Latest peer-reviewed research
Implementing A Successful Lean Programme: Where Do You Begin?
Use Of RFID Asset Management Systems For Monitoring Analytical Instrumentation
Understanding The Requirements For Effective Nasal Drug Delivery
More articles

Upcoming events
Quality of Medicines in a Globalised World: Dreams and Reality (14–15 October | Czech Republic)
Global Discovery Outsourcing and Collaborations Forum (21–20 October | UK)
Parenterals 2010: Integrating Process, Technology and Regulation (26–27 October | Germany)
More events

Product Profile
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...

Product Profile
Alfa Laval
Compabloc condenser: small is beautiful New biopharm film series
Compabloc is a revolutionary hygienic condenser solution that delivers outstanding reliability and heat transfer efficiency while dramatically reducing the footprint.

Read more...

Product Profile
Tepnel Pharma Services
ICSE 2010 conference
Tepnel Pharma Services will be showing its established and comprehensive range of laboratory testing services supporting small and large molecule analysis from early discovery and pre-clinical to first in man through to phase IV clinical support and post-marketing surveillance.

Read more...

Product Profile
Rotronic

The New Rotronic HygroLog NT data logger – Benefit from 20% discount !
The new HygroLog HL-NT data logger with HygroClip2 sensors and the AirChip3000 is a powerful system when there are many different physical parameters to record. The logger also meets all requirements for FDA, CFR Part 11 and GAMP compliance.

Read more...


Product Profile
Shimadzu

LC-30A Nexera – the cleanest and fastest
UHPLC ever to date

Shimadzu’s new LC-30A Nexera is unsurpassed in high-speed and high-resolution analysis and productivity. It meets the needs of the most demanding markets such as pharmaceutical and the food industry.

Read more...


Product Profile
Wockhardt
Thanks to expert staff, Wockhardt has become a leading global Pharmaceutical Contract Manufacturer. From development to high-volume commercial manufacture, we utilise more than 25 years of contract manufacturing experience to ensure your product is professionally managed all the way to market.

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Event Profile
Intertec
The Intertek Team will be launching some important new and expanded services at ICSE 2010. New services include GMP Microbiology Services and expanded capabilities for Extractable / Leachable studies.

Read more...




 

 
Survey
What is the most important feature of pharma secondary packaging?
Design
8%
Security
35%
Usability
16%
Child-resistance
8%
Environmental impact
20%
Cost
13%

This week we would like to know...

Did your company increase its level of outsourcing for small-molecule development and manufacturing in 2010 compared with 2009?
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