The health technology assessment body for England and Wales will need more resources to deal with the ‘surge’ in UK licenses in the early days of the new IRP. While measures are being put in place to mitigate challenges posed by the procedure, there could be long delays in HTA appraisals, more negative NICE decisions and more managed access agreements.
The UK’s new International Recognition Procedure (IRP) presents exciting opportunities in terms of earlier licensing of medicines, but also poses big challenges from a health technology assessment perspective that may test the agility of the current system run by the HTA institute, NICE.
The IRP could result in NICE not having clarity on companies’ pipelines, which can make it difficult for the institute...
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.
While the drug regulator has approved Eisai/Biogen’s early Alzheimer’s disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address.
It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
