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EC clears new class of anaemia therapy
pharmatimes
June 29, 2020
The European Commission has approved BMS’ blood disease therapy Reblozyl (luspatercept) for the treatment of transfusion-dependent anaemia associated with myelodysplastic syndromes (MDS) or beta thalassaemia.
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Janssen gets EC approval for subcutaneous use of daratumumab
pharmaceutical-business-review
June 09, 2020
Johnson & Johnson’s Janssen Pharmaceutical has secured approval from the European Commission for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of multiple myeloma in adult patients.
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Sanofi gets EC approval for Sarclisa to treat multiple myeloma
pharmaceutical-technology
June 04, 2020
Sanofi has received approval from the European Commission (EC) for the use of Sarclisa (isatuximab) with pomalidomide and dexamethasone (pom-dex) to treat adults with relapsed and refractory multiple myeloma (MM).
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Bristol Myers Squibb receives EC approval for Zeposia in adults with RRMS with active disease
pharmaceutical-business-review
June 01, 2020
Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
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Takeda gets expanded EC approval for lymphoma drug Adcetris
pharmaceutical-business-review
May 19, 2020
Takeda Pharmaceutical has secured expanded approval from the European Commission (EC) for its Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
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EC approves subcutaneous formulation of Entyvio as maintenance therapy in ulcerative colitis or Croh
pharmaceutical-business-review
May 13, 2020
Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab).
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EC approves Nilemdo™ (bempedoic acid) for lowering cholesterol
europeanpharmaceuticalreview
April 10, 2020
The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
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EC offers €80m to CureVac for COVID-19 vaccine development
europeanpharmaceuticalreview
March 20, 2020
The European Commision (EC) has announced €80 million of support to aid in the R&D and production of a COVID-19 coronavirus vaccine.
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EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
europeanpharmaceuticalreview
March 16, 2020
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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European Commission Grants AbbVie Marketing Authorization for Shorter MAVIRET Treatment
americanpharmaceuticalreview
March 09, 2020
AbbVie announced that the European Commission has approved a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration ...