UK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
The first-of-a-kind investment supports the UK government’s objectives to boost clinical trials, improve patient access to novel treatments and increase competitiveness in life sciences.
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
NICE’s recommendation of Yescarta® means it is the first time patients will be able to access CAR T-cell therapy long-term on the NHS.
The largest clinical trial of its kind will investigate if ketamine-assisted therapy can reduce harmful drinking in people with severe alcohol use disorder.
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
The IPPR urges the UK government to increase R&D funding to strengthen economic growth and restore the UK’s leading global position.
The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
Crizanlizumab recommended as a treatment option for preventing recurrent sickle cell crises for people aged 16 and over in the UK.
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.
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
AstraZeneca’s Calquence (acalabrutinib), a chemotherapy-free monotherapy, will be offered to patients with chronic lymphocytic leukaemia.