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  Pharmaceutical Technology Europe E-Alert
 
19 November 2012
IN THIS ISSUE
November issue
Manufacturing challenges
Alzheimer's challenges
Biosimilar mAbs
News
 
Top Pharma Stories for November
Extractables and leachables are the focus of this month’s issue of PTE Digital. E&Ls can lead to quality defects and more, and must be considered by pharma manufacturers. Other top stories this issue include quality by design, biosimilar mAbs and Alzheimer’s Disease. More...
 
Growing Area of Concern for Pharma Companies
Extractables and leachables are a growing area of concern for pharmaceutical regulators. Our roundtable of industry experts looks at the common types of E&Ls and how pharmaceutical manufacturers are tackling the challenges with analytical testing technologies More...
 
Europe's Alzheimer's R&D Crisis
The pharmaceutical industry is under pressure to deliver new therapies for Alzheimer’s disease, but regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation. More...
 
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
The  European Medicines Agency has released a guideline on biosimilar monoclonal  antibodies (mAbs) that lays down general principles for nonclinical and clinical studies on the  differences between biosimilar and reference mAbs. More...
 
Pharma News Roundup
If you’ve missed out on some of the top pharma news stories recently then our news roundup will update you. Highlights include Novasep’s chromatography plant, Europe’s first facility for cell-based therapeutics, and more. More...

Key Topics:
Latest blog posts
ABPI Issues Call to Improve UK Pharma
Will FDA Gain More Oversight Over Compounders
Changing Trends in laboratory Compliance
More blog posts

Latest news
Raid Captures 82 Million Doses of Counterfeit Drugs in Africa
Boehringer Ingelheim Settles False Claims Allegations
Watson Completes Acquisition of Actavis
More news

Upcoming events
Asia Pharma R&D Outsourcing Congress (26–27 November | UK)
World Drug Manufacturing Summit (26–28 November | Germany)
Pharma Integrates 2012 (28–29 November | UK)
More events

Products/Service Profiles
Shimadzu

Eliminate Ghost Peaks in UHPLC
Shimadzu has introduced the Ghost Trap™ DS-HP Series Columns which are designed to remove impurities from the solvent and system, enabling highly sensitive and reliable analysis.
Read more


Event profile

11th Annual World Drug Manufacturing Summit
26-28th November 2012
Venue: Swissôtel, Düsseldorf, Germany
The Annual World Drug Manufacturing Summit sources and presents leading global case studies from Pfizer, GSK, AstraZeneca, Baxter, Bayer and many more. Read More

Survey
Concerns have recently been raised about the safety of confidential data at FDA. Do you think regulators are doing enough to protect confidential data?
 
Yes 38%
 
 
No 63%

This week we would like to know...

2012 has been touted as a crucial year of the so-called patent cliff. Do you think the impact of patent expiries has been better or worse than expected?

Click here to vote

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