Sedana Medical seeks approval for inhaled sedation candidate Sedaconda
Sedana Medical has submitted an application seeking approval for its drug candidate Sedaconda (isoflurane), previously called IsoConDa, for inhaled sedation in intensive care. The application has been filed with the German Medicines Agency BfArM and various other European Medicines Agencies via the DCP procedure. The market approval application is based on the results of the […]
Opdivo EC approval : Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for its immunotherapy Opdivo (nivolumab) as a second-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in adults. The approval of the programmed death-1 (PD-1) immune checkpoint inhibitor is for patients who were previously subjected […]
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Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The approval is for the Opdivo/Yervoy combination to be used with two cycles of platinum-based chemotherapy in adult patients, whose tumors have no sensitizing epidermal growth […]
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Jyseleca EC approval : Gilead Sciences and Galapagos have secured marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets) from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults. The approval of the once-daily, oral, JAK1 inhibitor is rheumatoid arthritis patients who showed inadequate response […]
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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 […]
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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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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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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 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 […]
Continue reading …CytoSorbents gets CytoSorb EU approval for removal of ticagrelor during CPB
February 9, 2020 No Comment
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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