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EC strikes deal for supply of JNJ-78436735 Covid-19 vaccine candidate

EC strikes deal for supply of JNJ-78436735 Covid-19 vaccine candidate

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 […]

Kyowa Kirin gets extended EC approval for CRYSVITA in X-linked hypophosphataemia

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, […]

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Gilead, Galapagos bag Jyseleca EC approval for rheumatoid arthritis

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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AstraZeneca finalizes AZD1222 Covid-19 vaccine candidate deal with EC

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 […]

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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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Gilead Sciences announces Veklury EU approval for COVID-19 treatment

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 […]

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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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Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer

Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers. Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death […]

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