NICE, the organization that makes reimbursement recommendations for medicines used on the National Health Service in England and Wales, has provisionally turned down Santhera Pharmaceuticals’ Agamree (vamorolone) for funding, less than three months after the dissociative steroid was granted approval by the UK regulator, the MHRA.
England’s NICE Says No To Santhera’s DMD Drug Agamree Due To ‘Unreliable Modeling’
Santhera Pharmaceuticals did not provide enough evidence to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.
More from Europe
• By
While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
• By
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
• By
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.
• By
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
More from Geography
• By
While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
• By
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
• By
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.