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CHMP

Showing 15 posts of 110 posts found.

Sovaldi combo sees CHMP green light

September 29, 2014
Sales and Marketing CHMP, EU, Gilead, HCV, harvoni, hep C, sovaldi

The CHMP is recommending that Gilead’s new combination hepatitis C drug therapy Harvoni should be approved for use across the …

News
gsk image

Mekinist shown EU green light

July 7, 2014
Sales and Marketing CHMP, Cancer, GSK, Tafinlar, braf, mekinist, melanoma

The European Commission has given GlaxoSmithKline’s melanoma drug Mekinist the thumbs-up following a positive opinion in April from the European …

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BMS image

CHMP approves six drugs including daclatasvir

June 30, 2014
Sales and Marketing BMS, CHMP, HCV, Plavix, daclatasvir, daklinza, ge

A key advisory committee for the European Medicines Agency has given its approval to six new drugs at its latest …

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biogen_austria_238

Biogen gets CHMP thumbs up

May 27, 2014
Sales and Marketing Biogen, CHMP, Gazyvaro (obinutuzumab), Nuwiq, Octapharma, Orphan, Roche, chronic lymphocytic leukaemia, plegridy

Biogen Idec is celebrating after the Committee for Medicinal Products for Human Use (CHMP) gave its multiple sclerosis drug Plegridy …

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gsk image

Mekinist shown green light by CHMP

April 28, 2014
Sales and Marketing CHMP, Cancer, GSK, mekinist, oncology, trametinib

GlaxoSmithKline’s melanoma drug Mekinist is virtually nailed on to be given approval in the European Union following a positive opinion …

News

CHMP recommends Jardiance

March 24, 2014
Research and Development, Sales and Marketing Boehringer, CHMP, EU, diabetes, jardiance, lilly

Boehringer Ingelheim and Eli Lilly’s type 2 diabetes treatment Jardiance is among nine medicines which the Committee for Medicinal Products …

News

Europe poised for generic Symbicort

February 24, 2014
Manufacturing and Production, Sales and Marketing AstraZeneca, CHMP, COPD, Symbicort, Teva, breo, generics

The CHMP has given Teva Pharmaceutical Industries a lift by recommending that its generic version of AstraZeneca’s lung drug Symbicort …

News
GSK image

CHMP breathes new life into GSK, Teva and Novartis

February 24, 2014
Research and Development, Sales and Marketing CHMP, COPD, EMA, GSK, Gilead, Teva, asthma, onoro

The CHMP has given its backing to a number of new treatments for respiratory diseases, which include two from London-based …

News
Gilead image

‘Compassionate’ use of hep C combo

February 24, 2014
Research and Development, Sales and Marketing CHMP, EMA, Gilead, hep C, ledipasvir, sovaldi

A key adviser to the European regulator has said that Gilead Sciences’ fixed-dose combination of Sovaldi and ledipasvir can be …

News
gsk image

GSK/Theravance lung drug bags CHMP approval

February 21, 2014
Sales and Marketing CHMP, COPD, GSK, Theravance, anoro

The CHMP has given its backing to GlaxoSmithKline and partner Theravance’s new chronic obstructive pulmonary disease medicine Anoro. The treatment …

News
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 …

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