A freestanding UK Medicines and Healthcare products Regulatory Agency with a dedicated authorization route for new drugs OKd by the European Medicines Agency and national incentives for pediatric and orphan drug development are just some of the likely outcomes of a no-deal Brexit as described in a consultation document just released by the government. In many cases companies will end up paying again for services they currently receive from the EMA, and, the government says, they may pass these extra costs onto the national health service in the form of higher prices.
If the UK regulator, the MHRA, becomes a standalone agency and has to take on extra regulatory work from the EU in the event of a no-deal Brexit, it will have to charge the pharmaceutical industry additional fees, and companies may well decide to pass on these costs in the form of higher drug prices to the National Health Service.
This is one of the sobering conclusions drawn by the government in documents issued on Oct. 4 as part of...
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.
