Pharmafile Logo
Pharmafocus logo
Advanced Search

EMA

Showing 15 posts of 400 posts found.

AZ withdraws European filing for ovarian cancer therapy

September 22, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, EMA, cediranib, ovarian cancer

AstraZeneca is no longer seeker European approval for its oral multi-VEGF receptor inhibitor cediranib for treatment of ovarian cancer after withdrawing …

News
lilly_entrance_web

EU recommendation for Lilly’s soft tissue cancer drug

September 19, 2016
Sales and Marketing CHMP, EMA, Eli Lilly, Lartruvo, soft tissue sarcoma

The Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Lartruvo (olaratumab) for treatment of adults with …

News
bms

European Commission approves new RA treatment from BMS

September 6, 2016
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis

Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first …

News
lab

EMA accepts regulatory submission for proposed Herceptin biosimilar

August 26, 2016
Medical Communications Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab

Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for …

News
ema_inside

New therapy wins EMA orphan drug designation for ALS

August 9, 2016
Manufacturing and Production, Research and Development EMA, Ice Bucket Challenge, ab science, als, masitinib, oprhan drug designation

French pharma company AB Science has announced that the European Medicines Agency has granted orphan drug status to masitinib for …

News
4420456374_64a3d7e6aa

Top ten stories in the pharmaceutical industry this week

August 5, 2016
Medical Communications, Research and Development Actavis, Bioelectronics, CDF, Celgne, EMA, GSK, GlaxoSmithKline, Innovate UK, Medivation, NICE, Novartis, Roche, Sanofi, Teva, appointments, apremilast, biog, breast cancer, brexit, google, pharmaceutical industry, rheumatoid arthritis, sarilumab, top ten

It’s Friday, and we’ve seen some big developments in the industry’s headlines throughout the week, from news of Glaxo-Smith-Kilne’s new …

News
a_scientist_at_work_at_sanofis_immunology_laboratory_in_thailand

EMA accepts MMA for rheumatoid arthritis treatment Sarilumab

August 1, 2016
Research and Development, Sales and Marketing EMA, MAA, Regeneron, Sanofi, sarilumab

Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for …

News
ema_building_face_web

Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends

July 25, 2016
Manufacturing and Production, Sales and Marketing EMA, Novartis, Teva, manufacturing, semler

Following an FDA inspection and WHO investigation earlier this year, the European Medicines Agency (EMA) has recommended the suspension of …

News
ema_inside

EMA recommends two new treatments for advanced kidney cancer

July 22, 2016
Research and Development, Sales and Marketing EMA, Eisai, renal cell carcinoma

The European Medicines Agency (EMA) has recommended two new medicines for the treatment of advanced renal cell carcinoma, or kidney …

News
opdivo_1

Opdivo to go before EU, US regulators in head and neck cancer

July 19, 2016
Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo

Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …

News
samsung

Samsung Bioepis Humira biosimilar gets accepted for EMA review

July 18, 2016
Research and Development, Sales and Marketing EMA, Humira, Samsung Bioepis, application

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application from Samsung Bioepis for their biosimilar version …

News
pfizer_enbrel

New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile

July 7, 2016
Research and Development, Sales and Marketing Amgen, EMA, Enbrel, FDA, Novartis, Sandoz, biosimilars

Sandoz has announced new data confirming the equivalent safety and efficacy profile of their biosimilar version of Enbrel (etanercept) in …

News

Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation

Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …

News
novo_flag

Novo Nordisk says its insulin pump secures EMA marketing authorisation

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Novo Nordisk, insulin pump, marketing, product launch

Diabetes drugmaker Novo Nordisk (NYSE: NYO) said it has secured European Medicines Agency (EMA) marketing approval for its insulin pump.  …

News
msd

MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing CHMP, EMA, MSD, Merck & Co, keytruda, lung cancer

MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive …

News
The Gateway to Local Adoption Series

Latest content

BMS’ Opdivo/Yervoy combination accepted by Scottish Medicines Consortium for colorectal cancer

February 5, 2026

AstronauTx appoints Adam Rosenberg as Chair of the Board

February 5, 2026

Astellas Pharma’s Vyloy accepted by Scottish Medicines Consortium for gastric cancer

February 4, 2026

Angelini Pharma appoints Sergio Marullo di Condojanni as CEO

February 4, 2026

QV Bioelectronics secures £4.5m in funding for brain cancer therapy development

February 3, 2026