The Medicines and Healthcare products Regulatory Agency says it is in “everyone’s best interest” if clinical trial sponsors seeking UK approval for low-risk Phase III and IV studies make use of its new notification scheme that will cut the 30-day statutory evaluation timeline by more than half.
The UK has formally kick-started the overhaul of its clinical trials framework with the launch of a new notification scheme under which the regulatory evaluation timelines of the lowest-risk studies, for example some Phase III trials already authorized in the US or the EU, will be reduced by more than 50%.
The notification scheme is open to applications for initial Phase III and IV trials meeting certain criteria. Applications accepted into...
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.
