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PharmTech Europe
JUNE 23, 2015
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in this issue

EMA Launches Pediatric Drug Pilot Project
SGS to Open New QC Lab Near Paris
FDA Fights Online Counterfeit Drugs

Top Stories

Allergan Acquires Kythera for $2.1 Billion

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.
/ read more /


BIO Stresses Innovation with Name Change

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
/ read more /


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Industry News

Business Confidence in Pharma and Biotech Sectors Continue

Evaluate Pharma’s report shows upward trends in R&D and drug approvals.
/ read more /


EMA Launches Pediatric Drug Pilot Project

The agency creates initiative to stimulate pediatric drug development.
/ read more /


More Industry News

Supplier News

SGS to Open New QC Lab Near Paris

A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.
/ read more /


MFG Tray Recognizes Distributor

MFG Tray names ChemTech International as its first Master Pharmaceutical Distributor.
/ read more /


More Supplier News

Bio/Pharma News

Teva’s Patent for Copaxone Invalidated

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.
/ read more /


GSK Invests $95 Million in Gene Control Research

GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.
/ read more /


More Bio/Pharma News

Regulatory News

ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage

The International Conference on Harmonization finalizes Q&A document on APIs.
/ read more /


FDA Fights Online Counterfeit Drugs

The agency takes action against websites that illegally sell unapproved medications.
/ read more /


More Regulatory News

FEATURED TOPICS

INGREDIENTS

New Ways Around Hazardous Reagent Chemistry

Safer reagents and reaction conditions are making many hazardous transformations possible.
/ read more /

MANUFACTURING

Designing Clean Zones

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.
/ read more /

REGULATORY BEAT

EU’s New Post-Authorization Variations Framework Comes Under Scrutiny

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.
/ read more /

METHOD DEVELOPMENT

Streamlining Raw Materials Testing

The rapid testing of biologic raw materials can lead to greater efficiency.
/ read more /

DRUG DEVELOPMENT

Penn Announces Gene Therapy Collaboration with WuXi

The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.
/ read more /

OUTSOURCING

Fill/Finish Capacity Use for Biologics

There are significant differences between small molecules and biologics fill/finish capacity.
/ read more /


Product/Service Profiles

Adare Pharmaceuticals, Inc.

Overcoming complex formulation challenges.
Adding value to your products.

Have your medicines reached their full potential? Adare has the ability to solve complex formulation challenges and create or extend IP protection for new or existing medicines.
/ Read more /


Albany Molecular Research Inc.

Listen to AMRI's on-demand webinar, entitled “Trends in Quality Agreements & Communications: A CMO Perspective”, which was held on Tuesday, June 23, 2015 at 11 a.m. ET.
/ Read more /


Shimadzu

Breakthrough in purification
Shimadzu's ASAPrep for RPC (“Automated Scale-up from Analytical to Preparative conditions for Reversed Phase Purification”) predicts success and failure of purification automatically and determines an optimal preparative condition.
/ Read more /


Webcasts

Addressing Formulation Needs With a Different Technology: Say “Hello” to Ion Exchange Resins

Wednesday, June 24, 2015, 09:00 AM EDT

Ion exchange resins have long been in the formulator's toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by: Dow

Best Practices to Overcome Softgel Coating Challenges

(On Demand)

While softgels have become an increasingly popular method for the delivery of pharmaceuticals and dietary supplements, applying a functional coating to softgels is a challenging endeavor requiring precise formulation and finely tuned processing parameters. In this webcast, technical experts from BASF will share expertise on the key aspects of successful softgel coating.
Sponsored by: BASF


more webcasts

on pharmtech tv

PharmTech TV

External Lubrication in Tablet Production

Trends and Concerns in Capsule Production

Focus on Biobetters, Part 2

Feeding Powders in Pharmaceutical Processes

Events

29th Annual Symposium of The Protein Society

June 22–25, 2015 | Barcelona, Spain

42nd Annual Meeting & Exposition of the Controlled Release Society

July 26-29, 2015| Edinburgh, Scotland

PACK EXPO Las Vegas 2015

September 28–30, 2015 | Las Vegas, NV USA


more events

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 /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing eBook

The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, clean rooms, and lyophilization.


more ebooks
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