Europe – EMA starts review of cancer medicine Rubraca
EMA has started a review of the cancer medicine Rubraca (rucaparib camsylate) when it is used to treat cancer of the ovary, fallopian tubes...
Europe – EMA : Complex clinical trials – Questions and answers
This Q&A document provides guidance and seeks to support sponsors, clinical trialists and
applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT...
Europe – EC authorisation granted to kidney disease treatment Kinpeygo
The European Commission (EC) has granted conditional marketing authorisation for Kinpeygo (budesonide) capsules for the treatment of primary immunoglobulin A nephropathy (IgAN).
The treatment involves...
Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced...
EMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in...
UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision...
UK – European Commission Decision Reliance Procedure (ECDRP) extension
The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. From 1 January 2024 a new international recognition framework will be in...
UK – Ipsen reacts to NICE’s Cabometyx verdict
Ipsen has expressed its disappointed regarding the National Institute for Health and Care Excellence’s (NICE) preliminary guidance which does not recommend Cabometyx – also...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
The committee recommended granting a conditional...
Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature...
EMA has recommended granting a marketing authorisation in the European Union (EU) under exceptional circumstances for Zokinvy (lonafarnib), a treatment for patients with a genetically confirmed diagnosis of...
UK – NICE opts to reject Acorda’s MS drug Fampyra
The National Institute for Health and Care Excellence (NICE) has announced its decision to reject Fampyra – also known as fampridine – for use...
