EU

Showing 15 posts of 252 posts found.

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MHRA to consult on potential for no-deal Brexit

October 5, 2018
Medical Communications EU, MHRA, brexit, uk politics

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on how its legislation and regulatory processes would …

European countries unprepared for Alzheimer’s innovations, study shows

October 1, 2018
Sales and Marketing Alzheimer's dementia, Alzheimer’s & dementia, EU, Euroepan Union, RAND corporation, research

European healthcare systems are not prepared for new developments in preventative therapies for Alzheimer’s disease, according to research conducted by …

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EMA says pharma industry now more prepared for Brexit

September 27, 2018
Manufacturing and Production, Medical Communications EMA, EU, brexit, products, qppv

In July of this year the European Medicines Agency (EMA) identified significant gaps in the pharmaceutical industry’s preparedness for Brexit. …

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EU approval for Mylan and Fujifilm’s Humira biosimilar

September 21, 2018
Medical Communications, Sales and Marketing EU, Europe, Humira, Mylan, biosimilar, pharma

The European Commission has approved its fifth biosimilar of the world’s best-selling drug, Abbvie’s Humira (adalimumab), granting marketing authorisation to …

Novo Nordisk stockpiles 16 weeks’ worth of insulin in preparation for hard Brexit

September 10, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, Novo Nordisk, UK, brexit, insulin, pharma, stockpiles

Danish multinational Novo Nordisk has announced that they are increasing their stocks of insulin products to ensure that there are …

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Drug safety: UK and EU post-Brexit

September 10, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, Europe, MHRA, UK, brexit, drug safety, pharmacovigilance

What does Brexit mean for drug safety in Europe and the United Kingdom? Louis Goss looks into Britain’s exit from …

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Keytruda scores ground-breaking European approval in lung cancer subgroup

September 10, 2018
Sales and Marketing Cancer, EU, Europe, MSD, Merck, NSCLC, keytruda, lung cancer, pharma

Keytruda (pembrolizumab) has chalked up yet another approval for MSD, this time in Europe in combination with permextred and platinum-based …

Puma Biotech’s breast cancer drug authorised by European Commission, despite prior concerns

September 5, 2018
Research and Development Cancer, EU, breast cancer, ec approval, puma biotechnology

Puma Biotechnology have received European Commission marketing authorisation for Nerlynx (neratinib) despite prior concerns as to the safety and efficacy …

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Europe approves Janssen’s Darzalex in frontline multiple myeloma

September 4, 2018
Manufacturing and Production, Research and Development, Sales and Marketing EU, Europe, J&J, JJ, Janssen, darzalex, multiple myeloma, pharma

Janssen has revealed that its CD38-targeting biologic drug Darzalex (daratumumab) has received approval from the European Commission, authorising its use …

Pfizer says Brexit will cost the company $100 million

September 4, 2018
Manufacturing and Production EU, Pfizer, UK, brexit, pharma

The US multinational Pfizer has said that Brexit will cost the company $100 million in costs associated with the transference …

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AstraZeneca’s once-weekly auto-injector Bydureon BCise wins EU approval in type 2 diabetes

August 30, 2018
Research and Development, Sales and Marketing AstraZeneca, Bydureon, EU, Europe, diabetes, pharma, type 2 diabetes

AstraZeneca has announced that its auto-injector Bydureon BCise (exenatide 2mg prolonged-release suspension) has been approved by the European Commission for …

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Novartis’ Kymriah & Gilead’s Yescarta become first EU-approved CAR T therapies

August 28, 2018
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, Cancer, EU, Gilead, Kymriah, Novartis, UK, Yescarta, blood cancer, pharma

Almost one full year since the treatment was given a “historic” approval in the US, Novartis’ CAR T therapy Kymriah …

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Government publishes no-deal Brexit guidance, health secretary tells pharma companies to stockpile medicines

August 24, 2018
Medical Communications ABPI, EU, UK, brexit, government, stockpiling

The British Government has published a document offering guidance as to what should be expected in the case of a …

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ABPI Chief warns of Brexit impact on EU

August 10, 2018
Medical Communications ABPI, EU, UK, brexit, trade lobby

The head of the Association of the British Pharmaceutical Industry (ABPI) has warned that European governments have failed to recognise …

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MHRA sets out Brexit implementation period plan

August 7, 2018
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, MHRA, UK, brexit, implentation period

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have released an update which sets out what pharmaceutical and healthcare …

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