EU
MHRA to consult on potential for no-deal Brexit
October 5, 2018Medical 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, 2018Sales 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 …
EMA says pharma industry now more prepared for Brexit
September 27, 2018Manufacturing 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. …
EU approval for Mylan and Fujifilm’s Humira biosimilar
September 21, 2018Medical 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, 2018Business 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 …
Drug safety: UK and EU post-Brexit
September 10, 2018Business 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 …
Keytruda scores ground-breaking European approval in lung cancer subgroup
September 10, 2018Sales 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, 2018Research 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 …
Europe approves Janssen’s Darzalex in frontline multiple myeloma
September 4, 2018Manufacturing 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, 2018Manufacturing 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 …
AstraZeneca’s once-weekly auto-injector Bydureon BCise wins EU approval in type 2 diabetes
August 30, 2018Research 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 …
Novartis’ Kymriah & Gilead’s Yescarta become first EU-approved CAR T therapies
August 28, 2018Manufacturing 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 …
Government publishes no-deal Brexit guidance, health secretary tells pharma companies to stockpile medicines
August 24, 2018Medical 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 …
ABPI Chief warns of Brexit impact on EU
August 10, 2018Medical 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 …
MHRA sets out Brexit implementation period plan
August 7, 2018Manufacturing 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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