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ABPI responds to UK points-based immigration system
The ABPI has outlined how the new immigration system in the UK will affect life science workers and businesses, emphasising the need for regular reviews to remain competitive.
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Legal & Compliance
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European patent upheld for foundational CRISPR-Cas9 intellectual property
Arguments filed in opposition to a patent for foundation CRISPR-Cas9 intellectual property have been broadly rejected by the European Patents Office.
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Boris Johnson announces UK Global Talent visa for researchers
Boris Johnson, the Prime Minister of the UK, has announced a new Global Talent visa for researchers and scientists which will fast track those in certain fields.
whitepaper
Guidelines: 21 CFR Part 11 Compliance Checklist
The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations.
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Global consortium formed to combat unproven cell banking services
The International Society for Cell and Gene Therapy has created a group to tackle the rising number of commercial cell bank services that are misleading patients.
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Video: Ethical and regulatory use of biospecimens in the EU
Unique considerations surrounding the bureaucracy and oversight in the use of human biospecimens in the European Union.
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EU conditional marketing authorisation announced for ZYNTEGLO
ZYNTEGLO™ is the first gene therapy approved for transfusion-dependent β-thalassemia (TDT).
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Decision issued on US stem cell clinics accused of violating the law
The court held that the defendants adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
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US company put on notice for marketing unapproved stem cell products
Arizona company claims their products can treat Lyme disease, diabetes, Parkinson’s disease and more, but have not been approved for any use.
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Drug Target Review: Our 5 Steps to GDPR Compliance
The General Data Protection Regulation (GDPR) is a new set of EU rules governing how a company manages, protects and administers personal data. Whether you are a subscriber, author, advertiser or supplier to our journal, we may hold information about you and we need to keep it private and secure.
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Joint policy document shows the potential impact of Brexit
The associations representing the European and British life science industry have launched a joint policy document on the potential impact of the United Kingdom’s exit from the European Union...
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Budget 2017: Reaction from the UK’s pharmaceutical industry
The Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), Mike Thompson has responded to today's Budget announcement...
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EMA to relocate to Amsterdam, the Netherlands
The EMA will relocate to Amsterdam in the Netherlands. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest...
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Could Milan be the new home for the EMA?
Wayne Pines, President of Healthcare at APCO Worldwide in Washington DC and a former Associate Commissioner of the FDA believes Milan is a logical choice for the relocation of the EMA...
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Pistoia Alliance launches Chemical Safety Library Service
The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, has today announced the launch of the Chemical Safety Library (CSL) Service, which allows hazardous reaction information to be captured, stored and shared, to improve laboratory safety.
