Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years...
UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high...
Europe – DARWIN EU® has completed its first studies and is calling for new...
DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination...
UK – NICE sees ‘promise’ in four UTI tests that could help in fight...
AMR develops when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making them more resistant to drug treatments. As a...
UK – Recommendation from NICE for PTC Therapeutics gene therapy
Eladocagene exuparvovec, the only gene therapy for children with the ultra-rare genetic disorder, aromatic L-amino acid decarboxylase (AADC) deficiency, has been recommended by the...
UK – MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation...
A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster...
UK – MHRA to recognize foreign regulatory approvals for medicines and medical technologies and...
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high...
UK – NICE approves funding for Novartis gene therapy
NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec.
The treatment is a potentially curative one-off gene therapy...
UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary...
Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits...
Europe – EMA Q&A addresses submission of data elements for raw data pilot
The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical...
