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EC approves GSK-Pfizer consumer health JV with conditions
pharmaceutical-technology
July 12, 2019
The European Commission (GSK) has cleared GlaxoSmithKline (GSK) and Pfizer’s proposed merger of respective consumer health businesses to create a joint venture (JV).
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Pfizer secures EC approval for oral PARP inhibitor Talzenna
pharmaceutical-technology
June 26, 2019
Pfizer has secured approval from the EC for Talzenna (talazoparib) as a monotherapy to treat adult patients with germline breast cancer with gBRCA gene mutations.
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EC grants conditional approval for bluebird bio’s Zynteglo
pharmaceutical-technology
June 05, 2019
The European Commission (EC) has granted conditional marketing authorisation to bluebird bio’s gene therapy Zynteglo for the treatment of transfusion-dependent β-thalassemia (TDT).
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Celgene Receives EC Approval for Two Triplet Regimens Based on IMiD Treatments
americanpharmaceuticalreview
May 23, 2019
Celgene announced the European Commission (EC) has approved two new triplet regimens based on Celgene’s proprietary IMiD treatments, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).
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Sanofi gets EC approval for Dupixent to treat severe asthma
pharmaceutical-technology
May 10, 2019
Sanofi’s Dupixent has been approved by the European Commission (EC) as an add-on maintenance treatment for severe asthma in adults and adolescents.
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Dupixent® Approved for Severe Asthma by European Commission
americanpharmaceuticalreview
May 08, 2019
Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) approved a new indication for Dupixent® (dupilumab) in asthma.
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EC grants orphan drug designation for Gilteritinib for the treatment of AML
europeanpharmaceuticalreview
April 29, 2019
The European Commission has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia…
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EC approves Pfizer’s NSCLC drug Vizimpro
pharmaceutical-technology
April 23, 2019
EC approves Pfizer’s NSCLC drug Vizimpro
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AstraZeneca’s Lynparza gets EC approval for breast cancer
pharmaceutical-technology
April 23, 2019
The European Commission (EC) has approved AstraZeneca drug Lynparza (olaparib) as a monotherapy to treat locally-advanced or metastatic breast cancer in adults.
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EC approves Roche’s MabThera for a rare autoimmune disease
biospectrumasia
March 19, 2019
MabThera is the first biologic treatment approved for moderate to severe cases of the rare autoimmune disease pemphigus vulgaris (PV), and the first major advancement in the treatment of the disease in more than 60 years