Pharmaceutical Technology E-Alert:
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  Pharmaceutical Technology Europe E-Alert
 
8 January 2013

IN THIS ISSUE
FDA approvals
EMA workload
Amgen lawsuit
GSK and Vodaphone
Mylan recall

FDA Approvals of NMEs and BLAs Increased in 2012
The year 2012 proved to be a good one for FDA approvals of new molecular entities (NMEs) and new biologic license applications (BLAs), which have outpaced the number of approvals made in 2011. More...
 
EMA Reveals Work Programme for 2013
The management board of the European Medicines Agency (EMA) has endorsed the agency’s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012. More...
 
Amgen Settles False Claims Act Allegations
Amgen has pleaded guilty to a single misdemeanor count for illegally introducing a misbranded drug into interstate commerce and has agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs. More...
 
GSK Partners with Vodafone for Vaccinations
GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa. More...
 
Mylan Recalls Painkiller Pills Due To Risk of Higher Dosage
Mylan has issued a voluntary recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that they may exceed the potency stated on the label. More...
Key Topics:

Latest blog posts
A New Year in Pharma
Roche on Continuous Manufacturing: Industry Case Study
Purchaser of Unapproved Drugs Pleads Guilty
More blog posts

Latest articles
Tracking the Supply Chain
A Lifecycle Approach to Optimizing Cleaning Systems
Development and Commercialization of a Novel Modified Release Tablet Technology
More articles

Upcoming events
Pre-Filled Syringes (28–29 January | UK)
Parallel Trade in Life Sciences (5 February | UK)
iPharma2013 (11–12 February | US)
More events

Products/Service Profiles
Agilent

Together: It's how we work. It's how we help Pharma Succeed
Look to Agilent for real world solutions that help pharmaceutical companies discover more rapidly and more efficiently.
The Agilent RapidFire High-throughput System and 6550 iFunnel Q-TOF mass spec helped one lab reduce a week of work to 4.5 hours, transforming their productivity. Discover more, and request your free ADME Solutions Guide at our new pharma web. www.agilent.com/chem/togetherADME

 
Shimadzu

Nexera X2 – X-ceptional insights
Ultra-high sensitivity, expanded flexibility, increased stability and robustness - the new Nexera X2 UHPLC system targets routine analysis and applications in highly regulated environments demanding complex system setups. Read more


Event Profiles
Bio-Europe Spring

BIO-Europe Spring® 2013 — 7th International Partnering Conference
The seventh annual BIO-Europe Spring® conference is the premier springtime partnering conference for the biotechnology industry. For its 2013 edition, BIO-Europe Spring comes to Barcelona, Spain on March 11–13, 2013. Read more

 
Pharmapack Europe

13-14 February 2013, Grande Halle de la Villette, Paris, France
How Innovations in Pharma Packaging and Drug Delivery Technologies Enhance Patient Safety and Compliance. Read more

Survey
What area of the pharmaceutical industry do you think will experience the most change in 2013?
 
Manufacturing equipment and processes 12%
 
 
Outsourcing Services 16%
     
 
Drug delivery methods 10%
     
 
Information Technology 8%
     
 
Regulation policy and enforcement 18%
     
 
Biosimilars and generics 36%

This week we would like to know...

What area do you think will see increased regulatory attention and enforcement in 2013?

Click here to vote

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