UK – AstraZeneca/Merck’s Lynparza combination recommended by NICE for advanced ovarian cancer
The drug has been specifically recommended for NHS use alongside Genentech’s Avastin (bevacizumab) as a maintenance treatment in adults with advanced epithelial ovarian, fallopian...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
EMA’s safety committee, PRAC, has recommended new measures for medicines containing...
UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can...
UK – MHRA instructs health organisations to prepare now for new measures to reduce...
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase...
Europe – Pharma groups fight proposed ban on titanium dioxide in Europe
Pharmaceutical industry groups are working to submit comments to the European Medicines Agency (EMA) to oppose a proposed ban on the use of titanium...
UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in...
Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will...
UK – MHRA authorises world-first gene therapy for two inherited blood disorders
Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) is now the first licensed treatment that uses the gene-editing tool CRISPR, for which its inventors...
Europe – EMA seeks feedback on clinical development of vaccines for immunocompromised people
The European Medicines Agency (EMA) has published a draft concept paper on the clinical development of vaccines in immunocompromised individuals. EMA is seeking feedback...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.
The CHMP adopted a positive opinion for Omjjara* (momelotinib),...
