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National Institute for Health and Care Excellence (NICE)
Over 600 people may benefit as NICE publishes final draft guidance recommending osimertinib within the Cancer Drugs Fund.
The new draft guidance recommends Evrysdi (risdiplam) to treat spinal muscular atrophy as part of a managed access agreement (MAA).
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
The new draft guidance has recommended dapagliflozin as an option for treating certain people with chronic kidney disease (CKD) in adults.
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
NICE has recommended Pfizer’s Xeljanz® (tofacitinib) as an option to treat polyarticular juvenile arthritis and juvenile psoriatic arthritis.
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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…
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.
Liraglutide (Saxenda) will be offered to adults with non-diabetic hyperglycaemia and a high risk of cardiovascular disease.
The next Chief Executive of the National Institute for Health Research’s Clinical Research Network has been announced as Dr William van’t Hoff.