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PharmTech Europe
11 September 2018

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Top Stories

Novartis to Sell Parts of Sandoz

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $1 billion (EUR 900 million).
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FDA Expands NDMA Investigation to All ARB Class Drugs

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
/ read more /

Check out the PharmTech Europe Supplement on APIs, Excipients, and Manufacturing, includes the CPhI Worldwide Planning Guide.

August Supplement 2018
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Industry News

Alcami and UNCW Awarded Biomanufacturing Workforce Development Grant

Alcami and the University of North Carolina Wilmington received a grant worth $1.12 million (approximately EUR 1 million) from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.
/ read more /


Study Finds Candidate for Universal Flu Vaccine Protects Against Multiple Strains

Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.
/ read more /


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Regulatory News

Disputes Over SPC Waivers

The European Commission's proposed amendment on supplementary protection certificates (SPC) waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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EC Approves GSK’s Nucala for Pediatric Treatment of Severe Asthma

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
/ read more /


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Bio/Pharma News

Bayer Sells Prescription Dermatology Unit

Skin-focused company LEO Pharma acquired Bayer’s prescription treatment portfolio.
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Mylan Buys Novartis’ CF Products

The purchase of Novartis’ cystic fibrosis products TOBI Podhaler and TOBI solution for $463 million (EUR 400 million) is expected to strengthen Mylan’s global respiratory portfolio.
/ read more /


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Supplier News

SGS Increases Biopharma Characterization Capabilities

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.
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Sartorius Stedim Biotech and Repligen Corporation Partner to Introduce Perfusion-Enabled Bioreactors

A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.
/ read more /


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FEATURED TOPICS

EXCIPIENTS

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.
/ read more /

 

ANALYTICS

Classifying Potent and Highly Potent Molecules

Determining how much containment is needed for API handling requires evaluation of multiple factors.
/ read more /

EQUIPMENT

Robotics Solve Aseptic Filling Challenges

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.
/ read more /

OUTSOURCING

How to Address Roadblocks During Technology Transfer: A CDMO’s Perspective

Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.
/ read more /


Product Profiles

Thermo Fisher Scientific

Make Compliance a Competitive Advantage
Are you looking to ensure compliance to the latest demanding regulations? Do you need to be able to easily demonstrate control of your data? With Thermo Scientific™ Chromeleon™ CDS software you can rest assured.
/Read more/

Shimadzu

New C2MAP automated pretreatment module
Complete LC/MS solution for cell culture analysis

Celebrating this year the 50th anniversary of its presence in Europe, Shimadzu emphasizes its Excellence in Science approach through the release of the new C2MAP-2000 automated pretreatment module for cell culture media analysis.
/ Read more/

Events

SMi's 9th Annual Biosimilars & Biobetters Conference

London, United Kingdom

26–27 September 2018

CPhI 2018

Madrid, Spain

9–11 October 2018

Cell & Gene Therapy 2018

London, United Kingdom

10–11 October 2018

PDA Europe Pharmaceutical Microbiology

Berlin, Germany

15–16 October 2018


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.

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