Europe

Showing 15 posts of 198 posts found.

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Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy

September 24, 2018
Research and Development, Sales and Marketing CHMP, Duchenne Muscular Dystophy, EMA, Europe, Exondys 51, pharma, sarepta

Sarepta Therapeutics has been rocked by a hurdle in its pursuit of regulatory approval in Europe, as the company revealed …

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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 …

drug_safety

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 …

Europe-wide policy could boost generics market, study suggests

September 5, 2018
Research and Development Europe, generics, growth, markets, pharma

A Europe-wide policy covering the generic pharmaceutical market would facilitate significant growth in the pharmaceutical sector according to a new …

European Commission authorises first-ever rare blood condition drug

September 4, 2018
Manufacturing and Production, Sales and Marketing Europe, Sanofi, approvals, cablivi, eu commission

Sanofi have announced that the European Commission granted marketing authorisation for Cablivi (caplacizumab) for the treatment of adults experiencing an …

janssen_latest_logo_on_sign

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 …

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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 migraine prevention drug scores EU approval

July 31, 2018
Manufacturing and Production, Sales and Marketing Aimovig, Europe, Novartis, migraine, pharma

Novartis is celebrating the news that its calcitonin gene-related peptide receptor (CGRP-R) pathway therapy Aimovig (erenumab) has been approved by …

medicinal_cannabis_uk_review

European cannabis market set to be worth €115.7 billion by 2028

July 16, 2018
Sales and Marketing Europe, Legislation, cannabis, medicinal marijuana

The European cannabis market is set to be worth €115.7 billion by 2028, according to a report released by the …

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EMA issues global recall of heart drugs over cancer risk contamination

July 10, 2018
Manufacturing and Production EMA, Europe, heart disease, pharma, valsartan

Several drugs designed for the treatment of high blood pressure and heart conditions have been recalled across Europe over fears …

merckincweb2

MSD’s ulcerative colitis drug scores expanded indication in Europe

July 9, 2018
Sales and Marketing Europe, MSD, pharma, ulcerative colitis

New Jersey-based multinational MSD have announced that the European Commission (EC) has approved Simponi (golimumab) for early dose optimisation in …

Pfizer’s Xeljanz scores EU approval for active psoriatic arthritis

June 29, 2018
Medical Communications, Sales and Marketing EU, Europe, Pfizer, Xeljanz, pharma, psoriatic arthritis

Pfizer has announced that the European Commission (EC) has approved Xeljanz in combination with methotrexate (MTX) for the treatment of …

gilead-sciences

European Commission greenlights Gilead’s Biktarvy for HIV-1

June 25, 2018
Sales and Marketing Biktarvy, EU, Europe, European Commission, HIV, HIV-1, pharma

Good news for Gilead and HIV patients across the European Union today as the prominent pharma firm announced that its …

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AB Science will not seek review of masitinib rejection in Europe

May 29, 2018
Manufacturing and Production, Sales and Marketing EMA, Europe, ab science, als, masitinib, pharma

AB Science has U-turned on its pursuit of a do-over on its marketing application of masitinib in Europe after the …

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