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CHMP

Showing 15 posts of 100 posts found.

Teva image

Teva’s Great White Hope knocked back by Europe

January 27, 2014
Sales and Marketing CHMP, EU, MS, Nerventra, Teva

The drug designed to be a follow-up to Teva’s wildly successful Copaxone has been hit by rejection in Europe, leaving …

News

EU regulator recommended 81 medicines in 2013

January 21, 2014
CHMP, EC, EU, FDA, US, rare diseases

Last year the Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing approval, compared with just …

News

Gilead gets CHMP nod

November 25, 2013
Research and Development, Sales and Marketing CHMP, FDA, Gilead, chc, sovaldi

The CHMP has opened the way for Gilead Sciences’ first-in-class investigational chronic hepatitis C drug Sovaldi (sofosbuvir) to get to …

News
Xofigo

Bayer cancer drug gets EU approval

November 18, 2013
Sales and Marketing Bayer, CHMP, EU, Xtandi, Zytiga, xofigo

Bayer’s prostate cancer treatment Xofigo has been shown the green light by the European Commission.  Xofigo (radium Ra 223 dichloride) …

News
Actelion image

Positive CHMP verdicts for Actelion and Lundbeck

October 28, 2013
Sales and Marketing Actelion, CHMP, FDA, Lundbeck

Actelion and Lundbeck both took a step closer to EU approval for two drugs seen as pivotal to their future …

News
ema_building_face_web

CHMP recommends cancer ‘smart bomb’

September 23, 2013
Research and Development, Sales and Marketing CHMP, Cancer, EMA, Kadcyla, Roche

News
Remicade image

Remicade copies set for European entry

July 1, 2013
Sales and Marketing CHMP, Hospira, Janssen, Remicade, arthritis, biosimilar

Janssen’s Remicade could soon come under generic pressure after a landmark recommendation by the CHMP. South Korean biotech Celltrion and …

News
Genzyme image

Sanofi’s Lemtrada nears EU approval

July 1, 2013
Sales and Marketing CHMP, Genzyme, Lemtrada, Sanofi

Sanofi’s multiple sclerosis drug Lemtrada has received a positive recommendation from the CHMP, meaning a European approval is likely just …

News

Pfizer’s Xeljanz rejected in Europe

April 28, 2013
Sales and Marketing CHMP, Humira, Pfizer, RA, Xeljanz, rheumatoid arthritis

Pfizer has suffered a major setback with the rejection of its new arthritis drug in Europe.The EMA’s medicines committee the …

News
novartis image

EU approval for meningitis vaccine

January 23, 2013
Sales and Marketing Bexsero, CHMP, Novartis, meningitis

European regulators have approved Novartis’ Bexsero, making it the first broad coverage vaccine to target the leading cause of meningitis. …

News
Novartis image

Novartis eye drug nears approval

January 21, 2013
Sales and Marketing AMD, CHMP, Jetria, Novartis

Novartis’ eye drug Jetrea has been given a positive opinion by the CHMP, pushing it to the brink of approval. …

News

CHMP nod for Pfizer CML drug

January 21, 2013
Sales and Marketing CHMP, CML, FDA, Pfizer

Pfizer’s cancer drug bosutinib has been given a positive opinion by the CHMP for patients with chronic myelogenous leukemia (CML). …

News

Perjeta recommended in EU

December 18, 2012
Sales and Marketing CHMP, Cancer, Perjeta, Roche

Roche’s breast cancer treatment Perjeta has been given the thumbs up by the CHMP, paving the way for its approval …

News
genzyme image

CHMP turns down Kynamro

December 17, 2012
Sales and Marketing CHMP, Genzyme, Kynamro, Sanofi

Genzyme has expressed frustration at the CHMP’s negative opinion of its novel drug Kynamro, and plans to ask it to …

News

Novartis treatments set for approval

November 19, 2012
Sales and Marketing Bexsaro, CHMP, Novartis, exjade

Two Novartis drugs, meningococcal vaccine Bexsero and iron chelation therapy Exjade, have been given positive opinions by the CHMP, with …

News

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