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  Pharmaceutical Technology Europe E-Alert
 
7 September 2012

IN THIS ISSUE
Merck job cuts
Paediatric medicines
BMS recall
Janssen lawsuit
FDA inspections

Merck KGaA To Axe 10% of its German Workforce
Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015 — almost 10% of the company's 10,900 German positions. More...
 
EMA Seeks to Identify R&D Gaps in Paediatrics
The European Medicines Agency (EMA) has launched a public consultation concerning its inventory of paediatric medicines with the aim of highlighting where further R&D efforts are required. More...
 
Bristol-Myers Squibb Recalls Overfilled Vials of Chemotherapeutic Agent
Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) in the US that were previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company. More...
 
Janssen Pharmaceuticals to Pay $181 Million in Consumer-Protection Lawsuit
Johnson & Johnson's subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree in the US with regards to allegations related to the company's marketing and promotional practices for Risperdal (risperidone), which is used to treat schizophrenia and bipolar mania. More...
 
FDA Eyes More Foreign Inspections
It’s common knowledge that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to, but this situation is set to change in the near future. More...
 
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Key Topics:

Latest blog posts
FDA Eyes More Foreign Inspections
How Post-Market Feedback can Influence Compliance when Using a Quality Management System
IMS Predictions Foretell Positive Change
More blog posts

Latest articles
Regulatory Intervention in Paediatric Medicines
Tackling Tablet Sticking
Pre-use Filter-Integrity Testing: To Test or Not To Test?
More articles

Upcoming events
Biosimilars and Biobetters (24–25 September | UK)
Biological Production Forum (24–26 September | Germany)
Interphex Puerto Rico (4–5 October | Puerto Rico)
More events

Products/Service Profiles
Agilent

Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn more at www.agilent.com/lifesciences/realizepharma

 
Agilent

Agilent ICP-MS/ICP-OES
Reliable solutions for regulated pharmaceutical laboratories

Complying with new elemental impurity limits as defined by draft USP methods <232>/<233> could pose a significant challenge. You need to choose qualified hardware and software, ensure verification, and maintain electronic records. But there is a simple answer – Request a free copy of our primer on Elemental Impurity Analysis to learn more.

 
BASF SE, G-ENP/K

Soluplus® delivers new levels of solubility and bioavailability for poorly soluble APIs.
Exhibiting high flowability and extrudability, Soluplus® shows superior performance in forming solid solutions, especially in hot-melt extrusion processes. Read more

 
Shimadzu

Three new triple quads achieve a new global standard in mass spectrometry
Three new triple quadrupole mass spectrometers LCMS-8040, LCMS-8080 and GCMS-TQ8030 complete Shimadzu's UFMS series consisting of seven powerful systems. The UFMS product family provides higher sensitivity, greater excellence in data quality, increased analytical throughput and a wider range of applications. Read more

 

Event Profile

Bio-Europe
November 12-14 2012
Hamburg, Germany

BIO-Europe® is the preeminent partnering conference for the life sciences. BIO-Europe brings together international decision makers from the biotechnology, pharmaceutical and financial sectors, offering networking opportunities, workshop and panel participation, a high profile exhibition, and private, prescheduled one-to-one meetings. Read more

 
Survey
Has your company started implementing procedures and practices required by Europe's new pharmacovigilance legislation?
 
Yes 85%
 
 
No 5%
     
 
We are making progress 10%

This week we would like to know...

What do you think will be the greatest benefit of FDA's Generic Drug User Fees Amendments of 2012 (GDUFA)?

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