Pharmafile Logo
Pharmafocus logo
Advanced Search

CHMP

Showing 15 posts of 104 posts found.

White blood cells

CHMP recommend white blood cell growth stimulator biosimilar to EMA

July 30, 2018
Sales and Marketing Amgen, CHMP, EMA, Neulasta, biosimilar, chemotherapy, pegfilgrastim

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of two separate …

News
kymriah

CHMP recommends Novartis’ CAR-T therapy Kymriah for EU approval

July 5, 2018
Sales and Marketing CAR-T, CHMP, EMA, EU, Kymriah, Novartis, pharma

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T …

News

Novo Nordisk’s diabetes drug recommended for expanded indication in Europe

June 27, 2017
Research and Development, Sales and Marketing CHMP, EMA, EU, Novo Nordisk, Victoza

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to expand the indication of Novo …

News

Humira set to face new European biosimilar rival

June 26, 2017
Sales and Marketing CHMP, EMA, Samsung Bioepis

A position opinion from the EMA for Samsung Bioepis’ biosimilar of Humira looks set to unleash a second rival to …

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
shutterstock_179291957

CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment

July 25, 2016
Manufacturing and Production, Sales and Marketing BMS, CHMP, Orencia, rheumatoid arthritis

Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion of …

News
shire_image

Shire receives positive EU opinion for pancreatic cancer drug

July 25, 2016
Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire

Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …

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
cancer

Genmab’s CLL drug gets negative opinion from EMA committee

June 24, 2016
Medical Communications, Research and Development, Sales and Marketing Arzerra, CHMP, CLL, EMA, Genmab, blood cancer

Genmab A/S (Nasdaq Copenhagen: GEN) said its drug Arzerra (ofatumumab) received a negative opinion by the Committee for Medicinal Products …

News
biogen_idec_hillerod_2008

Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016
Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis

Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …

News
shire_image_4

Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment

Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …

News
biogen_austria_238

EMA recommends Biogen’s MS treatment Zinbryta

May 3, 2016
Research and Development, Sales and Marketing Biogen, CHMP, EMA, daclizumab, zinbryta

The Committee for Medicinal Products for Human Use (CMHP) has recommended the granting of a marketing authorisation for Zinbryta (daclizumab) …

News
EMA inside

Actelion’s Uptravi and rare bleeding disorder drug get positive EMA decisions

February 1, 2016
Sales and Marketing CHMP, EMA, Uptravi, pulmonary arterial hypertension, selexipag

The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has issued positive opinions on …

News

Samsung beats pharma to develop first EU-approved Enbrel biosimilar

January 18, 2016
Manufacturing and Production Benepali, CHMP, EMA, Enbrel, Samsung, Samsung Bioepis, etanercept, positive opinion

Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar …

News
EU flag

Three AstraZeneca drugs recommended by EMA committee

December 21, 2015
Sales and Marketing AstraZeneca, Brilique, CHMP, EMA, Portrazza, Tagrisoo, lesinurad, lilly

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended several new drugs in its latest meeting, including …

News

Latest content

Merck shares data from phase 3 trial of Keytruda for gastric cancers

May 2, 2024

Verona Pharma to share phase 3 COPD trial data at ATS 2024

May 2, 2024

Beckman Coulter Life Sciences and Watchmaker Genomics enter collaboration

May 1, 2024

Veru announces first patients enrolled in phase 2b trial for weight loss treatment

May 1, 2024

Bayer and Evotec to collaborate on precision cardiology

April 30, 2024