UK – Ipsen’s cabozantinib receives NICE approval for advanced hepatocellular carcinoma
Specifically, the recommendation is for adult patients who have had sorafenib – the standard initial treatment for advanced disease – only if they have...
UK – Merck’s Keytruda receives NICE recommendation as breast cancer treatment option
Specifically, NICE’s recommends Keytruda as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment after surgery for patients with early triple-negative or...
UK – MHRA updates biosimilar guidance to allow interchangeability between products
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use...
Europe – Guidance on the anonymisation of protected personal data and assessment of commercially...
This document aims at giving general guidance to companies on the retention/removal of Protected Personal Data (PPD) and identification of Commercially Confidential Information (CCI)....
UK – Digital cognitive behaviour therapies recommended by NICE across the NHS
The National Institute for Health and Care Excellence (NICE) has conditionally recommended digital cognitive behaviour therapies (CBT) for use in the NHS. It is...
Europe – Regulatory update – EMA encourages companies to submit type I variations for...
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2022 no later than Wednesday, 30 November 2022. This...
Europe – EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation
Previously, Vaxzevria was given a conditional Marketing Authorisation (cMA) due to the critical nature of the COVID-19 pandemic, and as further significant evidence of...
USA – FDA releases draft guidance to spur development of CDI drugs
The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).
The draft...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
Europe – EMA recommends measures to minimise risk of serious side effects with Janus...
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat...
