Ajovy bags NICE approval

UK – NICE recommends gene silencing therapy for porphyria patients on NHS

AHP is a group of rare genetic diseases, characterised by painful and potentially life-threatening attacks. It is caused by a genetic defect, and people...

Europe – EMA shares lessons learned from biosimilars pilot

The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice...
Nitrosamine contamination: new web page on EDQM response

Europe – Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders

Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs)...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – EC updates Clinical Trial Regulation Q&As ahead of January go-live

The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this...

Europe – EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5...

EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11. Comirnaty is a vaccine...
NICE OK for life-extending Vizimpro in lung cancer

UK – NICE approves Ofev for PF-ILD

The recommendation is supported by data from the Phase III INBUILD trial, which found Ofev met the primary endpoint of significantly slowing disease progression...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2021 meeting. Trodelvy (sacituzumab govitecan) was granted a...

UK – NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer

Opdivo has been cleared as an adjuvant treatment of completely resected oesophageal or GEJ cancer in adults who have residual disease following neoadjuvant chemoradiotherapy. The...

Europe – First-in-class medicine to treat aggressive form of breast cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – European Pharmacopoeia device version to be discontinued

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of...

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