Eliza began reporting on health and medical science in 2018 while completing her Master’s degree in Journalism at City, University of London. During her degree program she interned at C+D and on the London Evening Standard’s health desk. In the years since, Eliza has written about everything from mid-stage drug development to market access for medicines and devices in the EU and beyond. Her work explores the trials and tribulations of securing reimbursement for medical products in Europe, and Eliza is particularly interested in the challenges of funding innovation in health care. Eliza has lived in London since 2017 and is originally from Cheshire, in the north west of England. She has a first-class BSc in Biomedicine from Birkbeck College, University of London and a BA in English Literature from the University of Manchester.
Latest from Eliza Slawther
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.
While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.
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.
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.
While both the US and Europe have similar regulatory approaches to advanced therapy manufacturing, it is easier for patients in the US to access “out-of-specification” treatments if they have no other options, a biotech expert says.