CHMP

Showing 15 posts of 110 posts found.

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 …

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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 …

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 …

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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. …

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. …

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). …

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 …

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 …

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 …

European nod for Sanofi drugs

November 19, 2012
Research and Development, Sales and Marketing CHMP, Sanofi

Two of Sanofi’s key drugs have cleared the penultimate hurdle to approval in Europe with a recommendation from the CHMP. …

Eliquis image

Eliquis receives nod in AF

September 24, 2012
Sales and Marketing BMS, CHMP, Eliquis, Pfizer, Pradaxa, Xarelto

Bristol-Myers Squibb and Pfizer have received a boost with the CHMP’s recommendation that their co-marketed oral anticoagulant Eliquis should gain …

Cialis image

New possibility for Lilly erectile drug

September 24, 2012
Sales and Marketing CHMP, Cialis, ED, hyperplasia, lilly

Eli Lilly’s erectile disfunction (ED) brand Cialis has been recommended to treat benign prostatic hyperplasia (BPH) in Europe. If the …

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Afinitor’s new UK indication launched

September 20, 2012
Sales and Marketing Afinitor, CHMP, Novartis, breast cancer

Novartis’ cancer drug Afinitor has been made available in the UK for patients with the most common form of advanced …

EMA building

Salmonson is new chair of CHMP

September 19, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, MPA, Salmonson

Dr Tomas Salmonson has been elected chair of the Committee for Medicinal Products for Human Use (CHMP) for a three-year …

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