UK – Merck’s Keytruda combination recommended by NICE for advanced gastric cancer
The anti-PD-1 therapy has been specifically recommended for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat untreated locally advanced unresectable or metastatic human epidermal...
Europe – Alzheimer : l’Europe dit non au lecanemab… l’Amérique dit oui
18 mois après son autorisation aux Etats-Unis, le médicament anti-béta amyloïde s’est vu refuser une autorisation de mise sur le marché par le gendarme...
Europe – EMA addendum addresses vaccine development for immunocompromised people
The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2024 meeting.
The CHMP recommended granting a marketing authorisation for Anzupgo (delgocitinib), a medicine...
Europe – EMA advises about risks of using weight loss medicine Mysimba with opioids
Following a routine review of the safety of the weight loss medicine Mysimba (naltrexone/bupropion), EMA recommends strengthening existing advice to minimise the risks from...
UK – Boehringer Ingelheim’s Metalyse recommended by NICE to treat stroke in adults
The decision could help save the NHS millions of pounds due to Metalyse costing less than the current standard for treating this type of...
UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
The final draft guidance specifically applies to patients who have received at least three prior treatments, have progressed on their last treatment, and would...
Europe – Development and manufacture of oligonucleotides – Scientific guideline
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline...
UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment...
Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19...
In April 2024, the European Medicines Agency (EMA) issued a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the...
