CHMP
CHMP recommends cancer ‘smart bomb’
September 23, 2013Research and Development, Sales and Marketing CHMP, Cancer, EMA, Kadcyla, Roche
Remicade copies set for European entry
July 1, 2013Sales 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 …
Sanofi’s Lemtrada nears EU approval
July 1, 2013Sales 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, 2013Sales 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 …
EU approval for meningitis vaccine
January 23, 2013Sales 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 eye drug nears approval
January 21, 2013Sales 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, 2013Sales 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, 2012Sales 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 …
CHMP turns down Kynamro
December 17, 2012Sales 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, 2012Sales 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, 2012Research 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 receives nod in AF
September 24, 2012Sales 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 …
New possibility for Lilly erectile drug
September 24, 2012Sales 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 …
Afinitor’s new UK indication launched
September 20, 2012Sales 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 …
Salmonson is new chair of CHMP
September 19, 2012Business 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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