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  Pharmaceutical Technology Europe E-Alert
 
28 April 2015
IN THIS ISSUE
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Featured Content
Predicting Meaningful Process Performance
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. More...
 
FDA Steps Up Foreign Inspections
New legislation and changes in policy at FDA are leading to better control of the API supply chain. More...
 
Will Advances in Controlled Release Open Up New Drug Delivery Opportunities?
Emerging controlled-release technologies could lead to more effective therapies in the near future. More...
 
Top Stories
EMA Recommends Authorization of Melanoma Treatment
The agency has recommended granting marketing authorization for Opdivo. More...
 
Gauging Change in Europe's Sterile Manufacturing Market
The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed? More...
 
Industry News
Dicerna Receives Orphan Drug Designation for PH1 Treatment
Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation. More...
 
EMA Finds Scientific Advice Leads to Stronger Trial Design
The European Medicines Agency releases findings from marketing authorization application analysis. More...
 
Endolysin Technology Presents an Antibiotic Alternative with Broad Applicability
Endolysin technology targets unwanted bacteria, including resistant strains. More...
 
A Franchise Approach to the Modular Industry
Prequalified manufacturing suites could benefit from a new business model, say some industry executives. More...
 
Biosimilars May Spur Improvements in Reference Product Manufacturing Processes
Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market. More...
 
Serialization: Deja Vu All Over Again?
As a special session at Interphex 2015 made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk. More...
 
Hospira Recalls Bupivacaine HCl Injection
The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates. More...
 
Teva Proposes $40 Billion to Acquire Mylan
Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan. More...
 
Combination of Yervoy and Opdivo Shrinks Melanoma Tumors Drastically in NEJM Case Report
The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies. More...
 
L. B. Bohle's Technology Center Merges All Steps of Continuous Production
With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology, and controlling. More...
 
Webcasts
Practical Implementation of the New Elemental Impurities Guidelines
Tuesday, May 5, 2015, 11 am EDT / 15:00 CEST
Sponsored by SGS Life Science Services
 
Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
Thursday, May 14, 2015, 11 am EDT/8 am PDT/16:00 BST/17:00 CEST
Sponsored by Eurofins Lancaster Laboratories
 
Stability Assessment for Shipment of API and Drug Products
Thursday, May 21, 2015, 11 am EDT
Sponsored by Patheon
 
More Webcasts

Product/Service Profile
AirbridgeCargo Airlines

Efficient connections via Russia
AirBridgeCargo Airlines the largest Russian cargo airline provides customers with efficient connections from Asia to Europe and to the United States via Russia onboard Boeing 747 freighters.
Read more

Event Profile
CPhI Istanbul 2015 - The Leading Pharma Event in Eurasia

Date: 3rd - 5th June 2015
Venue: Istanbul Congress Center, ICC
CPhI Istanbul and co-located events P-MEC, InnoPack and ICSE will bring together local Turkish and regional (the Balkans, Central Asia, Middle East and North Africa) drug manufacturers with global suppliers of raw materials, machinery, packaging solutions and contract services (4 events under 1 roof).
Read more
 

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. ... Click here

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