CHMP
Sovaldi combo sees CHMP green light
September 29, 2014Sales 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 …
Mekinist shown EU green light
July 7, 2014Sales 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 …
CHMP approves six drugs including daclatasvir
June 30, 2014Sales 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 …
Biogen gets CHMP thumbs up
May 27, 2014Sales 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 …
Mekinist shown green light by CHMP
April 28, 2014Sales 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 …
CHMP recommends Jardiance
March 24, 2014Research 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 …
Europe poised for generic Symbicort
February 24, 2014Manufacturing 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 …
CHMP breathes new life into GSK, Teva and Novartis
February 24, 2014Research 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 …
‘Compassionate’ use of hep C combo
February 24, 2014Research 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 …
GSK/Theravance lung drug bags CHMP approval
February 21, 2014Sales 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 …
Teva’s Great White Hope knocked back by Europe
January 27, 2014Sales 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 …
EU regulator recommended 81 medicines in 2013
January 21, 2014CHMP, 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 …
Gilead gets CHMP nod
November 25, 2013Research 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 …
Bayer cancer drug gets EU approval
November 18, 2013Sales 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) …
Positive CHMP verdicts for Actelion and Lundbeck
October 28, 2013Sales 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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