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Basel, August 24, 2021 — Novartis today announced an update on the Phase III BELINDA study investigating Kymriah® (tisagenlecleucel) in aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment. The BELINDA study did not meet its primary endpoint of event-free survival compared to treatment with the…Cell and Gene TherapyCancer
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Basel, 21. September 2021 — Novartis hat heute die Übernahme von Arctos Medical bekanntgegeben. Das Unternehmen erweitert dadurch sein Portfolio in der Augenheilkunde um das präklinische AAV*-Gentherapieprogramm sowie die entsprechende Technologie von Arctos. Die Übernahme unterstreicht das Engagement von Novartis, Behandlungsmöglichkeiten für…OphthalmologyEye CareCell and Gene Therapy
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Bâle, le 21 septembre, 2021 — Novartis a annoncé aujourd’hui avoir acquis Arctos Medical, ajoutant à son portefeuille d’ophtalmologie un programme préclinique de thérapie génique AAV basé sur l’optogénétique et la technologie exclusive d’Arctos. Cette acquisition souligne l’engagement de Novartis dans la recherche de traitements pour les patients…OphthalmologyEye CareCell and Gene Therapy
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Basel, September 21, 2021 — Novartis today announced that it has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio. The acquisition underscores the Novartis commitment to finding treatments for patients with vision loss and the potential of…OphthalmologyEye CareCell and Gene Therapy
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Basel, October 30, 2020 — Novartis today announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah® (tisagenlecleucel) for patients in Japan. This approval makes FBRI the…Reimagine MedicineOncologyCell and Gene Therapy
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Basel, April 23, 2021 — Novartis today announced plans to initiate SMART, a Phase 3b clinical study to evaluate the safety and efficacy of Zolgensma® (onasemnogene abeparvovec) in young children with spinal muscular atrophy (SMA) weighing ≥ 8.5 kg and ≤ 21 kg, following a one-time, intravenous (IV) infusion. The new clinical data will supplement…Drug DiscoveryChildren's HealthCell and Gene Therapy
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Basel, December 9, 2019 – Novartis today announced results from two analyses of real-world experience with Kymriah® (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications. These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with…Targeted TherapyReimagine MedicineCell and Gene TherapyCancer
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Basel, March 19, 2020 — Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Zolgensma® (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA) in patients under the age of two, including those who are pre-symptomatic at diagnosis. Patients must be…Reimagine MedicineRare DiseasesCell and Gene TherapyAd Hoc
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Basel, March 24, 2020 – AveXis, a Novartis company, today announced that new data from the Phase 1/2 STRONG study demonstrated a one-time intrathecal (IT) administration of AVXS-101 in patients ≥2 years and <5 years old with spinal muscular atrophy (SMA) Type 2 who received Dose B (1.2 x 1014 vg) met the primary efficacy endpoint, achieving…Reimagine MedicineRare DiseasesCell and Gene Therapy
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Basel, March 24, 2020 – AveXis, a Novartis company, today announced a one-time infusion of Zolgensma® (onasemnogene abeparvovec-xioi) showed rapid, significant and clinically meaningful therapeutic benefit in patients with spinal muscular atrophy (SMA) across a range of studies, including in patients treated presymptomatically, and sustained…Reimagine MedicineRare DiseasesCell and Gene Therapy
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Basel, March 27, 2020 – AveXis, a Novartis company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending conditional marketing authorization of Zolgensma® (onasemnogene abeparvovec) for the treatment of patients with 5q spinal…Rare DiseasesInnovationCell and Gene TherapyAd Hoc
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Basel, April 22, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah® (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL). Kymriah, which is designed to be a one-…Reimagine MedicineOncologyCell and Gene Therapy