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Shire’s lyophilised Oncaspar receives positive CHMP opinion for ALL in Europe pharmaceufical-technology
October 17, 2017
The CHMP's positive opinion recommends the marketing authorisation of lyophilised Oncaspar as a component of antineoplastic combination therapy in ALL in paediatric patients from birth to 18 years and in adult patients.
CHMP backs one generic and six label extensions pharmatimes
October 17, 2017
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended just one generic medicine for approval at its October meeting.
Janssen reveals positive CHMP opinion, long-term data for psoriasis drug guselkumab pharmafile
September 20, 2017
Janssen has announced that its psoriasis drug guselkumab has been awarded a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP)
GSK and Innoviva receive positive opinion from CHMP for Trelegy Ellipta to treat COPD pharmaceufical-technology
September 19, 2017
Trelegy Ellipta is the proposed brand name for fluticasone furoate / umeclidinium / vilanterol (FF / UMEC / VI), which is co-developed by GlaxoSmithKline (GSK) and Innoviva.
CHMP backs 13 treatments for EU approval pharmatimes
September 19, 2017
Thirteen new therapies - including two biosimilars - have been backed for approval in Europe.
After 7 years, EC grants approval for Merck KGaA’s MS drug pharmafile
August 28, 2017
Pharmacovigilance is a science of understanding drug safety through identification, assessment, and prevention of adverse drug reactions (ADRs).
Novartis receives positive CHMP opinion for Rydapt cphi-online
July 25, 2017
If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU.
CHMP Issues Positive Opinion for Avelumab for Metastatic Merkel Cell Carcinoma americanpharmaceuticalreview
July 24, 2017
Merck and Pfizer announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab...
Cladribine Tablets receives positive CHMP opinion for treatment of relapsing forms of MS cphi-online
June 27, 2017
Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.
Merck’s Isentress receives CHMP positive opinion to treat HIV-1 infection pharmaceutical-technology
May 27, 2017
Merck’s Isentress (raltegravir) 600mg film-coated tablets have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the treatment of HIV-1 infection in adults and paediatric

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