Pharmaceutical Technology ePT Weekly
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PharmTech
June 30, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

CPhI 2016 Pharma Awards
Pfizer Builds Biotechnology Facility in China
Mayne Acquires Generics Portfolio

Top Stories

Next Steps Uncertain for the UK Pharma Industry Post Brexit Vote

In the wake of Britain's decision to exit the EU, pharma companies face uncertainty.
/ read more /


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.
/ read more /


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.
/ read more /


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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

CPhI Accepting Applications for 2016 Pharma Awards

The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.
/ read more /


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.
/ read more /


More Industry News
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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.
/ read more /


Charles River Acquires Blue Stream Laboratories

Charles River acquired Blue Stream Laboratories, an analytical contract research organization.
/ read more /


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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.
/ read more /


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.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Provides Quality Metrics Technical Conformance Guide

The agency publishes draft reference material for implementation of FDA's quality metrics guidance.
/ read more /


ICH Discusses Global Drug Development and Biopharma Guidelines

ICH detailed the highlights of the council's June 2016 meeting.
/ read more /


More Regulatory News
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For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.
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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.
/ read more /

GMPs

Make Data Integrity Integral to CGMP Training

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


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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
LIVE WEBCAST: Tuesday, July 12, 2016 | 11 am EDT
Free registration



VIEWPOINTS

Industry Moves Closer to Continuous Manufacturing

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.
/ read more /

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.
/ read more /


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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
On Demand
Learn more



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

more webcasts
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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
Read more



Events

MES 2016

August 10-11, 2016

Data Integrity Conference

August 17-18, 2016

PDA/FDA Joint Regulatory Conference

September 12-14, 2016

more events

REFERENCE BOOKS

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /

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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