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PCI Pharma Services to open new clinical center of excellence in Berlin

PCI Pharma Services to open new clinical center of excellence in Berlin

PCI Pharma Services, a drug development solutions provider, is set to expand its global clinical trial services with a new clinical center of excellence (COE) at its Berlin location in Germany. The pharma and biopharma outsourcing solutions provider said that the new center will enable it to grow its clinical supply-chain network into continental Europe […]

CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for avapritinib as a monotherapy for certain types of gastrointestinal stromal tumors (GIST). CHMP has recommended conditional marketing authorization of the kinase inhibitor in the European Union for […]

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Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU

Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC). The orphan medicinal product designation to the pro-drug in the European Union (EU) was granted in accordance with the opinion from the European Medicines Agency (EMA). Although hepatocellular carcinoma is considered to […]

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EC approves Reblozyl for transfusion-dependent anemia in adults

Bristol Myers Squibb and Acceleron Pharma have secured approval from the European Commission (EC) for their jointly developed erythroid maturation agent Reblozyl (luspatercept) for the treatment of transfusion-dependent anemia in adult patients. The approval of Reblozyl is for transfusion-dependent anemia caused by very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had […]

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Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]

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CytoSorbents gets CytoSorb EU approval for removal of ticagrelor during CPB

CytoSorbents has secured approval from the European Union (EU) for its CytoSorb extracorporeal blood purification therapy for the removal of anti-platelet agent ticagrelor during surgery requiring cardiopulmonary bypass (CPB). The CytoSorb whole blood adsorber has also been given CE Mark label expansion for the indication.  It was earlier approved in the European Union for the […]

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Pharma giants bag Lynparza EMA approval for metastatic breast cancer

Lynparza EMA approval : Pharma giants AstraZeneca and MSD have secured an expansion of the European Medical Agency’s (EMA) approval for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to be used for the treatment of a type of advanced breast cancer. The expanded Lynparza EMA approval allows the PARP inhibitor to be used as […]

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Praluent bags EC approval to reduce risk of CV events in patients with ASCD

Regeneron Pharmaceuticals and Sanofi have secured approval for Praluent (alirocumab) for a new indication from the European Commission (EC), which is for the reduction of cardiovascular risk in adults with established atherosclerotic CV disease (ASCD) by reducing low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correct other risk factors. Atherosclerotic CV Disease is defined […]

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Takeda bags ADCETRIS EC approval for CD30+ Stage IV Hodgkin lymphoma

ADCETRIS EC approval : The European Commission (EC) has expanded the approval of Takeda Pharmaceutical’s ADCETRIS (brentuximab vedotin) to cover treatment of previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients. ADCETRIS is an antibody-drug conjugate (ADC) that targets CD30, which is a defining marker of […]

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Novartis bags Gilenya EC approval for multiple sclerosis in young patients

Gilenya EC approval : The European Commission (EC) has expanded the approval of Novartis multiple sclerosis drug Gilenya (fingolimod) to include the treatment of both children and adolescents, in the age group 10-17 years. Expanded Gilenya EC approval The expanded Gilenya EC approval is for the treatment of relapsing-remitting forms of multiple sclerosis (RRMS). Novartis already […]

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