With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
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UK National Institute for Health and Care Excellence (NICE)
The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
Here, EPR explores some highlights of the UK’s new Life Sciences Vision for the pharma, biopharma and biotech industries, covering topics from funding to regulatory reviews and clinical trial innovation.
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
NICE has published draft guidance recommending Eli Lilly's twice-daily pill abemaciclib for advanced HER2-negative breast cancer.
Professor Tom Clutton-Brock was awarded an MBE for his work in approving novel ventilators for the UK’s National Health Service during the COVID-19 pandemic.
In this article, EPR summarises the list of 10 recommendations for the UK Government, published by experts in the medicinal cannabis industry, to ensure the UK capitalises on the opportunities afforded by the market.
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.