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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Novartis has announced that the European Commission has expanded the approval of its multiple sclerosis drug, Gilenya (fingolimod), to include the treatment of children and adolescents aged 10 to 17 years with relapsing-remitting multiple sclerosis. This approval marks Gilenya as the first oral disease-modifying therapy authorized for this younger demographic in Europe. Pioneering oral therapy […]
In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes concerning Pfizer’s proposed biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug, Humira (adalimumab). This agreement marks a major milestone in Pfizer’s mission to broaden its portfolio of biosimilar medications, as it acquires a non-exclusive patent license to market […]
In a significant development for melanoma treatment, the European Commission (EC) has granted Novartis approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib). This approval is specifically for adjuvant therapy in stage III melanoma patients who are positive for the BRAF V600 mutation and have undergone complete surgical resection. The approval is based […]
The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, […]