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Realising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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Clinical Trials
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Antibody response varies for Big Pharma COVID vaccines
Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines produced varied neutralising antibody levels when assessed for short- and long-term response, says study.
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Enzyme replacement therapy approved for Fabry disease
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
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EMA to review CTIS transparency rules
Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.
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Transforming oncology with antibody therapeutics
Martin Vogel, Therapeutic Area Lead for Oncology, Janssen EMEA, discusses the potential of bispecific monoclonal antibodies like amivantamab to address unmet needs in advanced non-small cell lung cancer treatment.
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European Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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Novel device opens blood-brain barrier to deliver chemotherapy
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
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Why R&D innovation holds the key to greater patient impact
How can innovation in clinical trials drive greater patient impact? BeiGene’s Dr Nils Eckardt and Dr Mieke Borgs highlight how novel systems and ways of working can support the delivery of high-quality medicines faster and more efficiently, helping to deliver greater and faster patient access in Europe.
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Biologic could be first new hidradenitis suppurativa treatment in a decade
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
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Immunotherapy to become standard treatment for infants with ALL
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
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Novartis releases data for potentially “practice-changing” PNH medicine
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.
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Pioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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Injectable small molecule inhibitor could improve vision
Long-term Phase II study data of small molecule inhibitor UBX1325 delivered significant vision improvements in diabetic macular edema (DME).
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Oral drug reduces treatment-resistant migraine frequency
Initial data from study results being presented at the 75th American Academy of Neurology Annual Meeting indicate that an oral CGRP inhibitor reduced episodic migraine frequency.
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FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
