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NICE approves inclisiran for LDL cholesterol reduction
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
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National Institute for Health and Care Excellence (NICE)
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NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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New regulatory guidance could lead to UK biosimilar boom
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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Making use of those ‘in the know’
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
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NICE recommends Liraglutide for treatment of obesity and non-diabetic hyperglycaemia
Liraglutide (Saxenda) will be offered to adults with non-diabetic hyperglycaemia and a high risk of cardiovascular disease.
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Dr William van’t Hoff next NIHR Clinical Research Network Chief Executive
The next Chief Executive of the National Institute for Health Research’s Clinical Research Network has been announced as Dr William van’t Hoff.
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NICE approves palbociclib with fulvestrant on the CDF for treatment of some breast cancers
The NICE committee has made palbociclib with fulvestrant available on the Cancer Drug Fund for patients with hormone receptor-positive, HER2-negative, advanced breast cancer.
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EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
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Hereditary angioedema treatment recommended by NICE
Lanadelumab, a preventive treatment for hereditary angioedema, has been recommended as a cost-effective use of NHS resources.
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NICE recommends voretigene neparvovec for use on NHS
The voretigene neparvovec gene therapy treatment has been highlighted in draft guidance by NICE for availability on the NHS.
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NICE to work with GW Pharma on cannabidiol evaluation
NICE and GW Pharma will work together to address the issues highlighted in its evaluation of cannabidiol for treating two types of epilepsy.
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Chief executive of NICE to leave role in 2020
Sir Andrew Dillion will be stepping down from his role as chief executive of NICE next year, after holding his position for 20 years.
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NICE releases draft guidance for using cannabis-based medicinal products
The NICE and NHS have announced their draft recommendations for the prescribed use of cannabis-based treatments.
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NICE recommends Lokelma treatment for hyperkalaemia
Lokelma, a treatment for hyperkalaemia in adults, has received a positive Final Appraisal Document from NICE after successful trials.
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NICE recommends risankizumab to treat severe psoriasis
NICE has issued a recommendation for risankizumab to treat patients with severe plaque psoriasis.
