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Spark Therapeutics bags Luxturna EU approval for inherited retinal disease

Luxturna EU approval for inherited retinal disease : Pennsylvania-based Spark Therapeutics has bagged the European Commission’s (EC) approval for its gene therapy Luxturna (voretigene neparvovec) to treat a rare inherited type of vision loss in both children and adults. Luxturna EU approval for inherited retinal disease Luxturna, an adeno-associated viral (AAV) vector gene therapy has […]

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EC approves label update for Novartis psoriatic arthritis drug Cosentyx

The European Commission (EC) has approved a label update for Novartis psoriatic arthritis drug Cosentyx (secukinumab) to include dosing flexibility for treating the condition. Cosentyx is the first and only fully-human treatment that precisely prevents interleukin-17A (IL-17A), in psoriatic arthritis, which is a chronic, progressive and irreversible disease that causes pain, fatigue, and also activity […]

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Merck bags EU approval for Keytruda chemo combo therapy for NSCLC

Merck has bagged the European Commission approval for the combination of its anti-PD-1 cancer immunotherapy Keytruda (pembrolizumab) with Lilly’s chemotherapy drug pemetrexed (ALIMTA) and platinum chemotherapy for the treatment of a certain form of metastatic nonsquamous non-small cell lung cancer (NSCLC). The latest Keytruda approval is for the use of the cancer combination therapy as […]

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Novartis skin cancer drug combo bags EC approval for type of melanoma

Novartis has secured approval from the European Commission (EC) for its skin cancer drug combo Tafinlar (dabrafenib) and Mekinist (trametinib) as an adjuvant therapy for stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. The latest approval marks the third for the Tafinlar-Mekinist combination in Europe for various tumor types identified with […]

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Janssen bags EC approval for daratumumab for multiple myeloma

Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorization for its monoclonal antibody Darzalex (daratumumab) from the European Commission (EC) as initial therapy for adult patients with newly diagnosed multiple myeloma, who are not eligible for autologous stem cell transplant (ASCT). The EC approval is for the use of daratumumab in combination with […]

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Hyrimoz EC approval : Novartis biosimilar of AbbVie Humira approved in EU

Hyrimoz EC approval : Novartis’ Sandoz has bagged approval for Hyrimoz (adalimumab), a biosimilar of AbbVie’s Humira (adalimumab), in Europe for all indications of the reference drug including rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis and ulcerative colitis. The approval of Hyrimoz by European Commission (EC) was driven by analytical, preclinical and clinical research that […]

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Amgen’s Parsabiv gets EC approval for treating SHPT

American biopharma company Amgen’s Parsabiv drug has been approved by the European Commission for treating secondary hyperparathyroidism. Secondary Hyperparathyroidism (sHPT) is a serious and chronic condition that affects millions of people throughout the world who are undergoing dialysis. Etelcalcetide branded as Parsabiv is intended to be used in adult patients with chronic renal disease, on […]

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