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PharmTech Europe

5 July 2016

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Top Stories

Pre-exposure to Dengue Virus May Predict Reaction to Zika Virus

Antibodies to dengue may either confer protective immunity to the Zika virus or enhance disease severity in secondary, related infections such as Zika.
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Sanofi and Boehringer-Ingelheim Sign on Business Unit Swaps

The companies agree to exchange ownership of Sanofi's animal health and Boehringer Ingelheim's consumer healthcare businesses.
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EXPERT INTERVIEW

Rajesh M. Dave, distinguished professor at the New Jersey Institute of Technology, sat down with Pharmaceutical Technology to discuss polymer thin films for drug delivery.

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Industry News

ICH Discusses Global Drug Development and Biopharma Guidelines

ICH detailed the highlights of the council's June 2016 meeting.
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NIH Researchers Develop Clinical-Grade Stem Cell Line

The cell lines have the potential to provide new medical applications for patients suffering from Alzheimer's disease, Parkinson's disease, spinal cord injury, diabetes, and muscular dystrophy.
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Regulatory News

EMA Recommends Suspension of Riluzole Alkem

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
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FDA Provides Quality Metrics Technical Conformance Guide

The agency publishes draft reference material for implementation of FDA's quality metrics guidance.
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Bio/Pharma News

Pfizer Builds Biotechnology Facility in China

The facility will be built in approximately 18 months using GE Healthcare's KUBio modular facility solution.
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Mayne Pharma to Acquire US Generics Product Portfolio from Teva and Allergan

Mayne entered into an agreement with Teva and Allergan to acquire 37 approved and 5 FDA-filed products.
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Bio/Pharma in China
New Initiatives, New Opportunities

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Supplier News

MilliporeSigma Collaborates with International Vaccine Institute

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.
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Charles River Acquires Blue Stream Laboratories

Charles River acquired Blue Stream Laboratories, an analytical contract research organization.
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FEATURED TOPICS

MANUFACTURING

PAT: “Gateway Drug” to the 21st Century for the Pharma Industry

Process analytical technology paved the way for continuous manufacturing.
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GMPs

Make Data Integrity Integral to CGMP Training

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
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VIEWPOINTS

Industry Moves Closer to Continuous Manufacturing

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.
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EU REGULATORY WATCH

Biosimilars: Making the Switch Comes with Challenges

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
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Webcasts

Comparing Performance of Gelatin Capsules and the Next Generation of HPMC Capsules

On Demand

New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC's role as a functional excipient.
Sponsored by Capsugel


Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements

On Demand
Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
Sponsored by Mettler Toledo


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Events

14th Annual Pharmaceutical IT Congress

28-29 September, 2016 | London, England

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany


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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.
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More Reference Library

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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