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First redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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Drug Safety
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Survey reports untapped potential for UK clinical trials
With the UK Government’s clinical trials landscape independent review expected, a survey has identified “huge untapped potential for trial recruitment”.
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First NICE-recommended treatment for chronic heart failure
In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection fraction.
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NICE recommends Rinvoq® for Crohn’s
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
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First treatment conditionally licensed for chronic hepatitis D
Gilead Science’s antiviral medication for chronic hepatitis D has been recommended by the National Institute for Health and Care Excellence (NICE).
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Intratumoural viral delivery improves glioblastoma survival
“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.
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Could personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
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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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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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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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First RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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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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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.
