Europe – Concept paper for the development of a guideline on the demonstration of...
The guideline on the pharmaceutical quality of inhalation and nasal medicinal products
(EMEA/CHMP/QWP/49313/2005 Corr) (which is under revision) covers, as the title indicates, both orally...
UK – BeiGene’s Brukinsa recommended by NICE to treat marginal zone lymphoma
The Bruton’s tyrosine kinase inhibitor, which is the first treatment to be specifically licensed for this form of blood cancer, is now available on...
USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
USA – FDA official clarifies misconceptions around RWE in premarket submissions
Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent...
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...
