Pharmafile Logo
Pharmafocus logo
Advanced Search

EMA

Showing 15 posts of 383 posts found.

FDA steps up 2018 drug approvals by 11% on previous year

August 1, 2019
Sales and Marketing EMA, FDA, drug approvals, pharma

The FDA continues to excel in the ground it covers as it emerges that the total number of new drug …

News
https__cdn

GW Pharma’s cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy

July 26, 2019
Medical Communications, Sales and Marketing EMA, Epidiolex, Europe, GW Pharma, cannabis, epilepsy

UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s …

News
top_10_image

Top Ten most popular articles on Pharmafile.com this week!

July 19, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMAL Therapeutics, Alzheimer's Ebola, Amgen, AstraZeneca, EMA, FDA, Novartis, pharma

On 12 July news broke that Novartis, Amgen and Banner’s Alzheimer’s Institute were discontinuing a trial into investigational compound CNP520 …

News
ema_logo

FDA and EMA fully implement mutual recognition agreement between US and EU

July 15, 2019
Sales and Marketing EMA, FDA, GMP, Slovakia, mra, mutual recognition, pharma

The FDA has recognised Slovakia’s ability to carry out inspections of manufacturing facilties. The recognition of Slovakia marks the full …

News
astrazeneca_building_white

AstraZeneca’s Farxiga fails to get FDA approval for patients with Type 1 diabetes

July 15, 2019
Sales and Marketing AstraZeneca, EMA, FDA, US, diabetes, farxiga

The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in …

News
janssen_latest_logo_on_sign

Janssen secures two positive CHMP opinions for Imbruvica label expansions

July 1, 2019
Sales and Marketing CHMP, EMA, Europe, Janssen, imbruvica, pharma

Janssen’s Imbruvica (ibrutinib) has racked up two positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human …

News
top_10_image

Top Ten most popular articles on Pharmafile.com this week!

June 7, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biogen, EMA, Janssen, Orkambi, Pfizer

It was revealed this week that Pfizer suppressed findings that their anti-inflammatory Enbrel reduced the risk of Alzheimer’s by 64%. …

News
credit_-_daniel_leal-olivas-afp

Use of Genzyme’s MS drug Lemtrada restricted under ongoing EMA safety review

April 16, 2019
Manufacturing and Production, Sales and Marketing EMA, Genzyme, Lemtrada, multiple sclerosis, pharma

The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues …

News
credit_-_daniel_leal-olivas-afp

CHMP recommendation for bluebird bio’s gene therapy in β-thalassaemia

April 1, 2019
Research and Development, Sales and Marketing Bluebird Bio, CHMP, EMA, Zynteglo, gene therapy, β-thalassaemia

Massachusetts-based bluebird bio has taken a significant leap forward in its pursuit of regulatory authorisation for its first gene therapy, …

News
astrazeneca_building_white

AstraZeneca scores accelerated approval in US and Europe for respiratory syncytial virus drug

February 5, 2019
Manufacturing and Production, Research and Development, Sales and Marketing AstraZeneca, EMA, FDA, MEDI8897, pharma, respiratory syncytial virus

It’s a double victory for AstraZeneca as the company announced its F monoclonal antibody MEDI8897 has been granted accelerated review …

News

EMA rejects Lilly’s Lartruvo in soft tissue cancer following trial failure

January 24, 2019
Sales and Marketing Cancer, EMA, Eli Lilly, Lartruvo, pharma

Eli Lilly has been dealt a blow as the European Medicines Agency announced its recommendation for soft tissue cancer patients …

News
credit_-_daniel_leal-olivas-afp

EMA approves more new active substances in 2018, but total recommendations fall

January 14, 2019
Sales and Marketing EMA, EU, Europe, drug approvals, pahrma

2018 was a strong year for European approvals according to the EMA; the regulator has recently released its Human medicines …

News
novartis_outside_1

Novartis withdraw marketing application for heart drug

December 17, 2018
Sales and Marketing CHMP, EMA, MI, Novartis, pharma

Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events …

News

First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee

November 20, 2018
Manufacturing and Production, Sales and Marketing CHMP, EMA, Europe, Sanofi, fexinidazole, pharma, sleeping sickness

Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a …

News
28246711066_52e38bc591_z

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. …

News

Latest content

Regeneron shares data for multiple myeloma treatment

December 8, 2023

Merck collaborates with Acceleration Consortium for AI experimentation

December 8, 2023

AbbVie to acquire Cerevel Therapeutics for approximately $8.7bn

December 7, 2023

ONK Therapeutics and NAYA Biosciences enter partnership for NK cell therapy development

December 7, 2023

FDA approves Novartis’ Fabhalta for PNH treatment

December 6, 2023