MHRA

News round-up by DDW Editor Reece Armstrong for 15-19 August. Covid booster approvals, positive results for Malaria vaccines and new CEOs are some of the stories in this week’s news round-up.  MHRA approves Moderna’s bivalent Covid booster   The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine […]

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Novartis UK’s treatment for a specific type of cancer.  The authorisation was granted for Scemblix (asciminib), Novartis UK’s therapy for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) who have previously been treated with two or more tyrosine […]

The Medicines and Healthcare products Regulatory Agency (MHRA) has partnered with three international organisations to bolster its position on setting standards for medicines and medical devices.    The MHRA has been accepted as a full member of the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and […]

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s oral inhibitor abemaciclib for the treatment of patients with a specific type of breast cancer.   Abemaciclib will now be able to be used in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human […]

Biotechnology company Rinri Therapeutics has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) for its cell therapy targeting a form of hearing loss.  The Innovation Passport, which is awarded through the MHRA’s Innovative Licensing and Access Pathway (ILAP), will enable Rinri Therapeutics to purse accelerated clinical development and […]

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in Great Britain.   The use of this medicine is for adults who are not currently infected with (or know exposure to) the Covid-19 virus […]