United Kingdom
Sponsors making “big statements” with “no evidence” to back them up is one of the biggest issues faced by the UK drug regulator when it is assessing the regulatory dossiers for advanced therapy medicinal products, a quality assessor from the Medicines and Healthcare products Regulatory Agency says.
Weight loss drugs have likely proven to be the most challenging medicines to introduce to the National Health Service in England, and lessons should be learned in preparation for other game changing products.
Lawyers from Sidley Austin tell the Pink Sheet how European drug manufacturers and marketing authorization holders should proactively deal with warning letters from the US Food and Drug Administration.
According to the health technology assessment institute, NICE, new cost-effectiveness thresholds – which are higher than those that applied when the original decisions were made – will apply when its committee reconsiders the appraisals for Eisai and Eli Lilly’s Alzheimer’s disease drugs.
Smaller biotech companies without the regulatory resources of big pharma should approach the UK medicines regulator and health technology appraisal body for early, informal discussions on how to generate the right evidence.
England’s health technology institute, NICE, said that Astellas’ non-hormonal drug for menopausal hot flushes, Veoza, should be funded for use via the National Health Service and that the drug addresses a “real and important” need for people who cannot take hormone replacement therapy.
The UK has announced a package of regulatory support measures to give the pharma industry a clearer pathway for bringing drugs manufactured in space to patients, leveraging microgravity to enhance the quality and stability of complex medicines.
European pricing and reimbursement processes, including in the UK, are on hold for now.
A regulatory sandbox and greater global harmonization will not only improve pathways for Indian cell and gene and other advanced therapies to reach the UK’s National Health Service but also speed up approvals in India
Pre-clinical models can help pharma companies to make better decisions on which drug candidates to take forward, but industry will need to work with academia to address shortcomings in the maturity of these technologies, UK trade association ABPI says.
Immedica’s Loargys is set to become the first disease modifying treatment for arginase 1 deficiency to be reimbursed in England. Meanwhile, the US regulator is reviewing a resubmitted marketing application for the product and has set a target action date of Feb. 23.
Revelations about a big underspend on England’s Innovative Medicines Fund for promising new non-oncology medicines have prompted calls for more transparency about how the money is allocated and how the fund is administered.
SGLT-2 inhibitors should be used to treat patients with type 2 diabetes much earlier in their treatment, the English health technology assessment institute said, adding that using generic dapagliflozin would save the National Health Service £560m.
The Pink Sheet’s investigation into England’s Innovative Medicines Fund has prompted calls for change from patients and industry representatives.
Data from virtual, artificial intelligence-based labs can help guide the clinical development pathway for pharmaceutical companies. But regulatory involvement will be key to assessing whether a virtual model is accurate, the CEO of Turbine Labs tells the Pink Sheet.
Challenges with identifying eligible patients within the England’s National Health Service care pathway meant there was insufficient evidence to support a full reimbursement application for Rozlytrek to treat NTRK fusion-positive solid tumors, Roche has said.
The UK could follow in the footsteps of its EU neighbors on tackling medicines supply chain challenges after a parliamentary group recommended changes that would boost national medicines manufacturing and protect the supply of critical medicines.
Pharma firms are keen to ensure that artificial intelligence tools used in the earlier stages of drug discovery are excluded from the “onerous scope” of the EU’s AI Act, as this could “defeat” the benefits of using this technology, says Clifford Chance’s Stephen Reese.
Improving patient recruitment speed will determine the future of the UK’s clinical trials landscape, experts argued at a webinar on the next steps for clinical research in the country.
External reference pricing is one of several drug pricing control measures used by a number of countries to contain drugs prices.