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NICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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National Institute for Health and Care Excellence (NICE)
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Adaflex: first UK-licensed melatonin for children with insomnia and ADHD
The drug provides a regulated treatment option for families in the UK impacted by sleep disorders related to ADHD.
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NICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
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New guidance to aid cost-effectiveness analysis of new drugs
The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.
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AstraZeneca’s PARP inhibitor newly recommended by NICE
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.
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Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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Alzheimer’s drug milestone “bittersweet” for certain patients
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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NICE recommends new haemolytic anaemia treatment
The National Institute For Health and Care Excellence (NICE)'s decision follows a reduction in the price of Pfizer’s small molecule treatment for sickle cell disease.
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NICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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NICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
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NICE recommends first medicine for severe alopecia areata
Clinical studies of Pfizer’s oral medicine for alopecia areata have demonstrated response rates continued to improve for up to two years.
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NICE recommends injectable bispecific antibody for aggressive blood cancer
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
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NICE recommends innovative breast cancer drug
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
