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PharmTech Europe

11 August 2015

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Top Stories

2015 CPhI Pharma Awards

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development. Deadline extended to 14 August, 2015.
/ read more /


Shire Proposes Combination with Baxalta

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxaltadeclines to discuss the proposal.
/ read more /


Ebola Vaccine Shows 100% Efficacy in Phase III Trial

World on the verge of an effective Ebola Vaccine according to WHO.
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FDA Approves First 3D-Printed Drug Product

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
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Bio/Pharma News

Shire Acquires Foresight Biotherapeutics for $300 Million

The acquisition strengthens Shire’s ophthalmics portfolio.
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Merck Signs Licensing Deal to Use Codexis’ Protein Engineering Technology

Codexis’ protein engineering platform will be used to develop novel enzymes for the manufacture of Merck’s pharmaceutical products.
/ read more /


More Bio/Pharma News

Supplier News

Xcelience Makes Investment in Powdersize

The investment adds particle-size control solutions to Xcelience’s capabilities.
/ read more /


EMD Millipore Collaborates with celares GmbH to Offer Pegylation Services

The new offering includes feasibility studies, process and analytical development, and scale-up services.
/ read more /


More Supplier News

Regulatory News

Indian API Manufacturer Cited for Recordkeeping Failures

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
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FDA Outlines Fees for Drug Compounding Companies

Companies that register as a drug-compounding outsourcing facility are required to pay fees to the agency.
/ read more /


More Regulatory News

Industry News

Silicone Rubber Pieces Spur Recall of Teva Product

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
/ read more /


FDA Issues Dissolution Testing Guidance

The guidance provides recommendations for immediate-release tablets and capsules that contain highly soluble drug substances.
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FEATURED TOPICS

EUROPEAN REGULATIONS

Regulation of Medical Devices and Companion Diagnostics

The trend towards personalized medicines requires a more integrated framework for the approval of devices and diagnostics.
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TROUBLESHOOTING

Implementing Electronic Production Records

Replacing paper records with electronic records has clear benefits, but making the switch requires careful planning and risk management.
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OUTSOURCING

Outsourcing Becoming More Cost Competitive

Biopharma companies are outsourcing more jobs to cut costs.
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INGREDIENTS

The Potential of Perfusion

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
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Product/Service Profile


Free White Paper: How Risk Management Tools can Improve Product Quality in Today’s Rapid Lifecycles

With the product lifecycle moving so fast, many organizations may ask the question, “how can we effectively measure quality?” What can an organization do to keep up with this new pace of business while ensuring the visibility that quality deserves? The answer is Risk Management.
/ Read More /



Webcasts

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

On Demand

Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by: Thermo Fisher Scientific


Practical Implementation of the New Elemental Impurities Guidelines

On Demand

The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs.
Sponsored by: SGS Life Science Services


more webcasts

on pharmtech tv

PharmTech TV

Application of External Lubrication in Tablet Production

Feeding Powders in Pharmaceutical Processes

Focus on Biobetters

Events

Swiss Biotech Innovation Day

August 19, 2015 | Zug, Switzerland

CPhI Korea 2015

September 7–9, 2015 | Seoul, Korea

Particles in Parenterals—State-of-the-art visual inspection of sterile medicinal products

September 16-17, 2015 | Berlin, Germany


more events

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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 /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.


more ebooks
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