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CHMP

Showing 15 posts of 100 posts found.

Takeda image

Takeda trials Teva Parkinson’s drug in Japan

January 9, 2015
Sales and Marketing Azilect, CHMP, Copaxone, Parkinson's, Takeda, rasagiline

Takeda has begun late stage trials for Teva’s Parkinson’s disease drug Azilect in Japan, with the hopes of bringing the …

News
Ranbaxy image

Ranbaxy launches J&J biosimilar in India

December 5, 2014
Manufacturing and Production, Sales and Marketing CHMP, FDA, India, J&J, JJ, Ranbaxy, Remicade, nlem, nppa

Ranbaxy has launched the first biosimilar of Johnson & Johnson’s Remicade (infliximab) in India, marking the firm’s entry into monoclonal …

News
BI image

CHMP nods several drugs through

November 24, 2014
Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev

Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among …

News
AZ image

AZ oncology drug a ‘Phoenix from the flames’

October 27, 2014
Sales and Marketing AstraZeneca, CHMP, EC, lynparza, olaparib, oncology

As the possibility of a deal with Pfizer fades, AstraZeneca is continuing its argument for independence as a key cancer …

News

Scenesse recommended for rare sun disease in Europe

October 27, 2014
Sales and Marketing CHMP, Clinuvel Pharmaceuticals, EMA, EU, scenesse

The European Medicines Agency is recommending that Scenesse (afamelanotide) be approved for the prevention of severe sun burn in adults …

News

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 …

News
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

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