Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or...
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...
USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs
The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated...
USA – FDA Says Face-to-Face Meetings Include Virtual
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled...
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)....
International – ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers
Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug...
USA – FDA finalizes umbrella trial guidance for cell and gene therapies
The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...
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...
