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...
Canada – Update : Validation rules for regulatory transactions provided to Health Canada in...
Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information...
USA – FDA updates guidance on evaluating out-of-specification results for drugs
The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including...
International – FDA, EMA officials discuss impediments to cell and gene therapies
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and...
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...
