Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS)...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting.
A recommendation for marketing authorisation was adopted...
Europe – Synchron Research Service: suspension of medicines over flawed studies
EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located...
Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
EMA has recommended granting a marketing authorisation in the European Union (EU) for Upstaza (eladocagene exuparvovec), a therapy for the treatment of adult and paediatric patients...
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...
Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
The COVID-19 vaccine candidate can now move from the initial rolling review process to the formal review process, which is overseen by the Committee...
UK – NICE recommends app-based treatment for insomnia over sleeping pills
NICE has recommended Sleepio as an effective alternative to sleeping pills. The move would save the NHS money as well as reducing prescriptions of...
UK – MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer...
Eli Lilly’s Verzenios (abemaciclib) has received a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), in combination with endocrine therapy for...
UK – COVID-19 vaccine study focuses on young and immunosuppressed
Immunosuppressed transplant recipients between the ages of 12 to 17-years-old have been added to the MELODY study population, which analyses how well additional doses...
UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer
The regulatory approval is specifically for adults whose tumours present a protein called PD-L1 on at least 1% of tumour cells and whose disease...
