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PharmTech Europe
03 April 2018

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Top Stories

GSK Buys Out Novartis’ Share of OTC Business

In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.
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bioLIVE to Launch Global Biopharma Country Ranking

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.
/ read more /

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Industry News

Avoiding Complete Response Letters

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
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FDA: Early Stage Drug Development Costs Trigger Higher Drug Costs

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.
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Regulatory News

EMA Recommends Two Biosimilars, One Orphan Drug, for Approval

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
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FDA Warns of the Potential of Contamination at API Facility

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
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Bio/Pharma News

Helix BioPharma Partners with ProMab on CAR-T Therapies

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.
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Helsinn to Acquire Rights to Skin Cancer Drug

Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.
/ read more /


More Bio/Pharma News

Supplier News

Wuxi Biologics to Install Large-Scale Single-Use Bioreactor

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.
/ read more /


Thermo Fisher Expands Clinical Distribution in Europe

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.
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FEATURED TOPICS

MANUFACTURING

Best Practices for Testing Foreign Particulate Matter in Inhaled Products

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.
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SOLID DOSAGE

A QbD Approach to Shorten Tablet Development Time

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.
/ read more /

FORMULATION

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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ANALYTICS

Improving Operations in the Lab

New and emerging products advance bio/pharma laboratory operations.
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Product Profiles

Eurofins BioPharma Product Testing

Comprehensive GMP Laboratory Testing Services
From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
/ Read more/


LIVE WEBCASTS

Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
Live Webcast: April 10 at 11:00am EDT
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now


Improve Data Transparency and Collaboration Across your Manufacturing Network
Wednesday, April 25 at 10:00am EDT
Register now


ON DEMAND WEBCASTS

Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
On Demand
Learn more


Real-Time Process Control for Healthy, High-Purity Water Systems
On Demand
Learn more


Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
On Demand
Learn more


Events

Making Pharmaceuticals 2018

Coventry, UK

24–25 April 2018

ACHEMA 2018

Frankfurt am Main, Germany

11–15 June 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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