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Brexit – Implications For the Pharma Industry in Ireland

  Brexit – Implications For the Pharma Industry in Ireland

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still

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EMA to Work With Stakeholders to Improve Product Information For EU Medicines

  EMA to Work With Stakeholders to Improve Product Information For EU Medicines

The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients

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New Precision Medicine Centre of Excellence Will Improve Patient Treatment

  New Precision Medicine Centre of Excellence Will Improve Patient Treatment

A £10 million Centre of Excellence in Precision Medicine has been launched by Invest Northern Ireland and Queen’s University Belfast.

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Diaceutics Wins at Export Industry Awards

  Diaceutics Wins at Export Industry Awards

Diaceutics, the Irish data insights and solutions company helping patients receive potentially lifesaving medicine through better testing, won the Small

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Brexit – Key Issues For the Pharmaceutical Industry

  Brexit – Key Issues For the Pharmaceutical Industry

Brexit – the stark reality is that the UK’s EU membership and the application of all EU legislation in the UK

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European Commission Diagnoses the State of Health in the EU

  European Commission Diagnoses the State of Health in the EU

Only by rethinking our health systems can we ensure that they remain fit-for-purpose and provide patient-centred care. This is what

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Anti-Pancreatic Cancer Drug In Research Focus

  Anti-Pancreatic Cancer Drug In Research Focus

Intriguing antitumor activity is found in a very promising class of natural compounds: cyclic depsipeptides, which have a challenging structure

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Biopharma firm Regeneron to create 300 jobs in Limerick

  Biopharma firm Regeneron to create 300 jobs in Limerick

US biopharma company Regeneron Pharmaceuticals is to create 300 new jobs in Ireland as part of a new $100 million

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Brexit: Implications for the Pharma Industry in Ireland

  Brexit: Implications for the Pharma Industry in Ireland

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still

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FDA collaboration uses Organs-on-Chips to improve drug development

  FDA collaboration uses Organs-on-Chips to improve drug development

CN Bio Innovations Limited has announced today that it has entered into a Research Collaboration Agreement with the US Food

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Rapid Micro Biosystems to develop final implementation of rapid sterility test for vaccines

  Rapid Micro Biosystems to develop final implementation of rapid sterility test for vaccines

The company as been awarded the contract by the US Biomedical Advanced Research and Development Authority (BARDA). Rapid Micro Biosystems,

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Ireland and the Life Science Industry – 2017

  Ireland and the Life Science Industry – 2017

The Life Science Industry The manufacturing industry in Ireland is now enjoying a renewed period of growth on the back of

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Tarloxitinib puts tumour-seeking tail on anti-EGFR drug to target lung cancer

  Tarloxitinib puts tumour-seeking tail on anti-EGFR drug to target lung cancer

EGFR is a common genetic target in lung cancer, but not all EGFR mutations are created equal. Patients with a

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Anticoagulant drugs appear to reduce the risk of stroke in patients with AF

  Anticoagulant drugs appear to reduce the risk of stroke in patients with AF

Blood-thinning drugs not only reduce the risk of stroke in patients with atrial fibrillation (AF) but are also associated with

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Responsibilities of the Marketing Authorisation Holder

  Responsibilities of the Marketing Authorisation Holder

Marketing Authorisation Holder: EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime

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Biogen takes up option to co-develop Eisai AD drug

  Biogen takes up option to co-develop Eisai AD drug

Biogen and Eisai have expanded their existing collaboration agreement to develop and commercialise investigational therapies for Alzheimer’s Disease. Eisai has

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Ketamine may help treat migraine pain unresponsive to other therapies

  Ketamine may help treat migraine pain unresponsive to other therapies

Ketamine, a medication commonly used for pain relief and increasingly used for depression, may help alleviate migraine pain in patients

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Spotlight on Trends for API Warning Letters from October 2015 – June 2017

  Spotlight on Trends for API Warning Letters from October 2015 – June 2017

API Warning Letters Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued

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Reduce SOP Complexity – Top 10 Tips

  Reduce SOP Complexity – Top 10 Tips

Standard operating procedures (SOP’s) define the essential steps, their order and the instructions necessary to formally repeat a quality performance.

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