NICE collaboration creates new route for medicines approval
A collaboration between the UK’s National Institute for Health and Care Excellence (NICE), the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England and NHS Improvement and equivalent organisation in Scotland has created a new route for medicine approval within the UK.
The new Innovative Licencing and Access Pathway (ILAP) aims to ease the process between clinical trials and patient access to new medications through closer collaboration and planning between the respective agencies. The pathway is focused on ensuring that NHS patients can gain access to innovative new medicines in a simpler and faster way.
The MHRA and NICE will work together to advise companies on clinical trial design, with the aim of ensuring optimal data is generated for regulatory approval and health technology appraisal.
Read the full article in the PharmaTimes.
Researchers develop new rapid Covid-19 RNA test
Researchers from the University of Birmingham have created a new RNA test for Covid-19, which they say can reduce testing time to under five minutes while still delivering accurate results.
The method has been published in a preprint paper on MedRxiv, meaning that it has not yet been peer-reviewed, although the University of Birmingham Enterprise has filed a patent application covering the method and its use in diagnostic equipment.
The preprint paper demonstrates the rapidity and sensitivity of the method using a patient sample RNA provided by Public Health England. Currently, the ‘gold standard’ test for Covid-19 has been the Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, which takes over an hour per sample.
Read the full story in the PharmaTimes.
Allergy Therapeutics launches biomarker study of peanut allergy vaccine candidate
Allergy Therapeutics has initiated a biomarker study at Imperial College London, with the aim to evaluate its novel virus like particle based peanut allergy vaccine candidate.
The study will use human samples and a set of functional and molecular biomarkers to establish the starting dose to be used for its first-in-human phase I study of the VLP-based vaccine candidate.
”A safe and effective short-course peanut allergy vaccine would be a significant breakthrough product, offering life-changing benefits to sufferers affected by this condition. The data we have generated for our peanut vaccine candidate gives us confidence in its potential.” said Manuel Llobet, chief executive officer of Allergy Therapeutics.
Read the full story in the PharmaTimes.
Two more life-saving Covid drugs identified, which can cut deaths by a quarter in seriously ill patients
Two more life-saving drugs have been found that can cut deaths by a quarter in patients who are seriously ill from Covid-19. The anti-inflammatory medications, which are given via a drip, can save an extra life for every 12 treated say researches who have carried out a trial in NHS intensive care units.
The supplies of the drugs – tocilizumab and sarilumab – are already available across the UK so they can be used immediately to save hundreds of lives, say experts. The UK government is working closely with the manufacturer, to ensure the drugs continue to be available to UK patients.
As well as saving more lives, the treatments speed up patients’ recovery and reduce the length of time that critically-ill patients need to spend in intensive care by about a week.
Although the drugs are not cheap, costing around £750 to £1,000 per patient, the advantage of using them is clear – and less than the cost per day of an intensive care bed of around £2,000, say experts.
Read the full story in the BBC.
Quote of the week
This week NICE announced it’s collaboration on the the new Innovative Licencing and Access Pathway (ILAP), which aims to ensure that NHS patients can gain access to innovative new medicines in a simpler and faster way.
Commenting on the newly formed ILAP, Lord Bethell, Minister for Innovation said: “The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible,”
Read the full story in PharmaTimes.