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 […]
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 […]
Continue reading …Johnson & Johnson (J&J) said that the European Commission (EC) has approved an advance purchase agreement for securing 200 million doses of the JNJ-78436735 Covid-19 vaccine candidate (Ad26.COV2.S) developed by its subsidiary Janssen Pharmaceutical Companies. Currently, the JNJ-78436735 vaccine candidate is being evaluated in the phase 3 ENSEMBLE Covid-19 vaccine trial across certain countries. The […]
Continue reading …Kyowa Kirin has secured extended approval for CRYSVITA (burosumab) from the European Commission (EC) in X-linked hypophosphataemia (XLH), to cover the treatment of older adolescents and adults. Previously, CRYSVITA was approved for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children, aged one year and older and adolescents with growing skeletons, […]
Continue reading …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 […]
Continue reading …AstraZeneca said that it has finalized a deal with the European Commission (EC) for the delivery of up to 400 million doses of the AZD1222 Covid-19 vaccine candidate (formerly ChAdOx1 nCoV-19). The deal is said to consolidate on the existing agreement with Europe’s Inclusive Vaccines Alliance led by Germany, France, the Netherlands, and Italy. It […]
Continue reading …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 […]
Continue reading …Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19. According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic […]
Continue reading …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 […]
Continue reading …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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