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  Pharmaceutical Technology Europe E-Alert
 
15 April 2014
IN THIS ISSUE
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Featured Topics
Increased Efficiency Key to Competitiveness in Downstream Bioprocessing
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing. More...
 
Navigating the Regulatory Landscape of Combination Products
Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products. More...
 
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas. More...
 
Medicare Payment Data Raises Questions About Drug Costs
Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices. More...
 
Top Stories
Takeda, Lilly to Challenge $9 Billion Verdict in Diabetes Drug Case
Takeda Pharmaceuticals and Eli Lilly announced that they plan to challenge a $9 billion judgment in a lawsuit that alleged Actos caused a patient's bladder cancer. More...
 
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
A new report from PhRMA outlines potential growth trajectories affecting the biopharmaceutical industry. More...
 
FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines
FDA develops an assay that could speed the release of pandemic influenza vaccines. More...
 
Center for Biologics Evaluation and Research Relocates
CBER will move to the FDA White Oak campus in Silver Spring, Maryland. More...
 
Industry News
PolyTherics and MacroGenics Extend ADC Collaboration
ThioBridge linker technology to attach different payloads to a range of antibodies. More...
 
Desktop Human Body Developed for Toxicity Testing
The Advanced Tissue-engineered Human Ectypal Network Analyzer project team is developing realistic human organs for testing. More...
 
Fette Appoints New President
 Fette appoints Sean Scully as its new president. More...
 
uniQure Announces Management Changes
uniQure appoints a new COO and vice president, Medical affairs. More...
 
Molecular Profiles Invests in Hot Melt Extrusion Technology
Molecular Profiles expands technology with GMP hot melt extrusion. More...
 
Webcasts
Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Tuesday, April 22, 2014 at 11 AM-Noon EST
Tuesday, April 29, 2014 at 10:00-11:00 AM CET

Sponsored by: SGS Life Science Services
 
Life Cycle Management Opportunities In Softgel Technologies: Regulatory and Technological Aspects
Wednesday, May 21, 2014 at 11:00 AM EDT
Sponsored by: Patheon
 
Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach
On Demand
Sponsored by: Mettler Toledo
 
More Webcasts

Product Profiles
Agilent
Agilent Solutions for Quality by Design
Agilent’s new QbD Solutions Guide provides information about Agilent tools and technologies to help you minimize variability in analytical method development and analytical method transfer, and support quality by design implementation.   Agilent strives
to provide solutions you need to be successful, and to earn
your trust as a partner in implementing solutions. Download your guide here
Colder Products Company
Make sterile connections faster, easier and safer with genderless connectors
Simplify single-use systems with AseptiQuik® genderless connectors from CPC. Innovative design eliminates separate male and female components to reduce system complexity and inventory requirements, while increasing process flexibility. Read more
Optima Pharma GmbH
Meeting highest requirements of the pharmaceutical sector - OPTIMA pharma
The concept offers an immensely diversified and innovative range of filling and packing machines for pharmaceutical products, e.g. sterile liquids and powders, non-sterile liquids and powders, pharmaceutical freeze-drying as well as isolation and containment technology. Read more
Powder Systems Ltd
Universal Multi-Mill Glovebox
The Universal Multiple Mill Glovebox for Multiple Mill Systems is part of the Contained Powder Handling product range from original pioneers of high containment technology Powder Systems Limited. PSL’s multiple mill isolator can accommodate different mills in a single glovebox. Read more
 
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Reference Library

Pharmaceutical Technology Outsourcing Guide
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. ... Click here


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