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Restriction of hazardous substances in tattoo inks

15-Mar-2019

ECHA’s Committee for Socio-economic Analysis (SEAC) adopted its final opinion supporting the proposal by Denmark, Italy, Norway and ECHA to restrict the placing on the market of tattoo inks and permanent make-up. Substances within the scope of the restriction include carcinogenic, mutagenic and ...

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Merck Awarded Canadian CRISPR Nickase Patent for Foundational Genome-Editing Technology

05-Mar-2019

Merck announced that the Canadian Patent Office has allowed Merck’s patent application directed to the use of paired CRISPR nickases in eukaryotic cells. The patent provides an important and more specific solution for scientists who need accurate methods when developing treatments for ...

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ECETOC Task Force provides new insights

Toxicity testing of microparticles and poorly soluble liquids in the water environment

15-Jan-2019

A Task Force set up by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) has provided new insights into scientific testing for the impact of undissolved particles in the aquatic environment. ECETOC launched the Task Force in response to increasing concerns among the ...

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Opening the way for global innovation in biotechnology

New agreement supports sharing, innovation and openness

16-Oct-2018

A new easy-to-use legal tool that enables open exchange of biological materials is launched. The OpenMTA is a Material Transfer Agreement (MTA) designed to support openness, sharing and innovation in global biotechnology. Material Transfer Agreements (MTAs) provide the legal frameworks within ...

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Recipharm releases first serialised products to Europe

12-Oct-2018

Recipharm has released its first serialised products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden. In 2016 Recipharm committed to invest 40 million euros in preparing its facilities for the European Falsified Medicines Directive (EU FMD). The release of its first batch ...

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Combined resistance to multiple antibiotics: A growing problem in the EU

17-Nov-2017

On the occasion of the 10th European Antibiotic Awareness Day, the European Centre for Disease Prevention and Control (ECDC) is releasing its latest EU-wide data on antibiotic resistance, as well as its guidance on prevention and control of carbapenem-resistant Enterobacteriaceae (CRE). In 2016, ...

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Focus on Medical Device Regulation

BVMed, Earlybird, High-Tech Gründerfonds and BIOCOM publish “MedTech Radar 9”

15-Nov-2017

The EU Medical Device Regulation heralds a new era for the medical technology sector: in future, any company wishing to bring medical devices to market must face the requirements of this new regulatory framework. This implies a sizeable challenge for the many small and medium-sized enterprises in ...

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EPA to Grant Merck’s Patent Application for CRISPR Technology

Related patent application recently awarded in Australia

04-Aug-2017

Merck announced the European Patent Office (EPO) has issued a “Notice of Intention to Grant” for Merck’s patent application covering the company’s CRISPR technology used in a genomic integration method for eukaryotic cells. The patent will provide Merck’s CRISPR genomic integration technology ...

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EMA prepares for Brexit

Business continuity plan aims to preserve Agency’s ability to protect public and animal health

02-Aug-2017

The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation. “Preparing for the move, managing the ...

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New ISPE Good Practice Guide

Decommissioning of Pharmaceutical Equipment and Facilities

19-Jun-2017

The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guidance document, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. This guide provides an overview of best practices to be used for the decommissioning and ...

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