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PharmTech Europe
11 April 2017

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Top Stories

Drug Approvals in 2016: Europe vs. US

A drop in US drug approvals was noted but this trend was not yet seen in Europe.
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GlaxoSmithKline Recalls 600,000 Asthma Inhalers in US

The recall was issued because of a defective delivery system; the units affected had possible package leakage.
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Mylan Announces Expansion of EpiPen Recall to the US

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.
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Industry News

EMA to Collaborate More Closely with Academia

EMA has developed a framework and action plan to foster relationships with the academic community.
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Political and Ethical Dilemma's Facing Bio/Pharma Companies in a Global Marketplace

Ben Locwin and Tom Fox discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.
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Regulatory News

EMA Issues Guidance on Periodic Safety Update Reports

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
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Study Compares Regulatory Review at FDA with EMA

A new study in NEJM compares the regulatory review processes of FDA and EMA.
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More Regulatory News

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Bio/Pharma News

Finch and Takeda Collaborate on IBD Therapies

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.
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EMA Grants Orphan Drug Designation to Epidiolex for Treatment of Lennox-Gastaut Syndrome

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.
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Supplier News

Sartorius Acquires Umetrics for $72.5 Million

Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.
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Sharp Invests in Multi-Phase Pharma Facility in Wales

The company has invested GBP9 million (approximately $11.6 million) to fund a new multiple-phase pharmaceutical manufacturing, packaging, and distribution facility in Wales, United Kingdom.
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FEATURED TOPICS

FACILITIES

Using Solar Energy for Process Heating

Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
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SUPPLY CHAIN

Serialization Hits the Home Stretch

As the November 2017 deadline nears, a surprising number of companies still don't have a serialization plan in place. New programs aim to get them compliant in time.
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ANALYTICS

Characterization and Impurity Analysis of Oligonucleotide Therapeutics

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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HIGHLY POTENT

Understanding Containment

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.
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Product Profiles

DIOSNA Dierks & Söhne

Coater Modul for MINILAB XP
The MINILAB XP by DIOSNA is a well-known laboratory processor. With our new Coater Modul we offer a unit with a fluid bed processor and a horizontal coater in one.
/ Read more/

Eurofins BioPharma Product Testing

GMP Laboratory Testing Services
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
/ Read more/

Veltek Associates, Inc.

Process2Clean®: Process Cleaning Detergents
VAI's Process2Clean®, Process Cleaning Detergents, are designed to remove process residues that could contaminate or adulterate further product manufacturing in the pharmaceutical, biotechnology, medical device, and research & development industries.
/ Read more/


UP COMING WEBCAST

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Understanding Pharmaceutical Elemental Impurity Regulations and Laboratory Considerations
Live Webcast: Thursday, April 20 at 11:00am EDT
Register now


Events

Making Pharmaceuticals

Coventry, United Kingdom

25–26 April 2017

Respiratory Drug Delivery (RDD) Europe 2017

Nice, France

25–28 April 2017

OSD Continuous Manufacturing in the Current Regulatory Landscape

Floriana, Malta

8–9 May 2017


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.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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