Pharmafile Logo
Pharmafocus logo
Advanced Search

EU

Showing 15 posts of 252 posts found.

remdesivir_ulrich_perrey

EMA could approve Gilead’s streamlined remdesivir application for COVID-19 “within weeks”

June 9, 2020
Manufacturing and Production, Sales and Marketing COVID-19, EU, Gilead, coronavirus, remdesivir

The European Medicines Agency has received the application from Gilead for the first conditional marketing authorisation (CMA) of its antiviral …

News
bmssyracuseny

BMS’ Zeposia becomes first S1P receptor modulator available in Europe for relapsing remitting multiple sclerosis

May 28, 2020
Sales and Marketing Avonex, Bristol-Myers Squibb, EU, Europe, Zeposia, bristol myers squibb, multiple sclerosis

Bristol Myers Squibb is celebrating after its oral therapy Zeposia (ozanimod), secured European Commission for the treatment of relapsing remitting …

News
800px-european_commission_flags

Positive CHMP opinion for BMS and Acceleron’s Reblozyl in transfusion-dependent anaemia sub-populations

May 1, 2020
Medical Communications, Sales and Marketing Acceleron, Bristol-Myers Squibb, EU, Reblozyl

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal …

News
novartis_outside_1

EU approval for Novartis’ Cosentyx in active non-radiographic axial spondyloarthritis

April 29, 2020
Research and Development, Sales and Marketing Cosentyx, EU, Novartis, axial spondyloarthritis, pharma

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial …

News
boehringer_biberach_germany_copy

Boehringer’s nintedanib approved in Europe for systemic sclerosis-associated interstitial lung disease

April 22, 2020
Research and Development, Sales and Marketing Boehringer Ingelheim, EU, nintedanib, pharma

The European Commission has moved to authorise Boehringer Ingelheim’s nintedanib in Europe for the treatment of systemic sclerosis-associated interstitial lung …

News
europe-1395916_640

Drug launches across Europe will be affected by coronavirus

March 20, 2020
Medical Communications, Sales and Marketing EU, Europe, coronavirus, pharma

The COVID-19 pandemic will affect European launches of drugs for a host of diseases including HIV, cancer and sickle cell …

News
512px-ursula_von_der_leyen

European Commission offers €80m to CureVac to develop coronavirus vaccine

March 17, 2020
Manufacturing and Production, Research and Development, Sales and Marketing CureVac, EU, US, coronavirus

Following confirmation of reports that US President Donald Trump sought to persuade a biotech to provide US-exclusivity for a potential …

News

Sanofi secures expanded European approval for Toujeo in type 1 diabetes

January 10, 2020
Medical Communications, Sales and Marketing EU, Sanofi, pharma, toujeo

Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine 300 units/mL) to include …

News
abbvie_0

AbbVie granted EU marketing authorisation for new arthritis drug

December 19, 2019
Business Services AbbVie, EC, EU, arthritis, rheumatoid arthritis

AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible …

News
shutterstock_138095450

Transactions in the pharma sector: Through the EU merger review looking-glass

December 9, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, feature, mergers & acquisitions, pharma

With mergers and acquisitions back in full swing after a period of drought, Alec Burnside (Partner) and Delphine Strohl (Associate) …

Feature
astrazeneca_sign_sky

AstraZeneca’s Qtrilment scores European authorisation in type 2 diabetes

November 15, 2019
Medical Communications, Sales and Marketing AstraZeneca, EU, Europe, Qtrilmet, diabetes, pharma, type 2 diabetes

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) has secured approval in Europe, its manufacturer AstraZeneca has revealed, as a therapy to …

News

Promising Phase 3 data for Sanofi’s Toujeo secures CHMP recommendation of label expansion in type 1 diabetes

November 4, 2019
Research and Development, Sales and Marketing EU, Sanofi, Type 1 diabetes, diabetes, pharma, toujeo

Sanofi took the opportunity at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts to …

News

European Commission approves Sanofi’s Dupixent in chronic rhinosinusitis with nasal polyposis

October 30, 2019
Research and Development, Sales and Marketing Dupixent, EU, Sanofi, pharma

Sanofi’s Dupixent (dupilumab) has secured European approval for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), it has emerged. …

News
brexit-hintergrund_web

“No deal” Brexit and life sciences: What happens?

October 21, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, Europe, UK, brexit, no deal, no-deal, pharma

Prime Minister Boris Johnson may have agreed a withdrawal agreement with the European Union at the 11th hour, but despite …

Feature
celltrion1

Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation

September 24, 2019
Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …

News
The Gateway to Local Adoption Series

Latest content

STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025