UK – Theramex’s Eladynos recommended by NICE for post-menopausal bone disease
Theramex’s Eladynos (abaloparatide) has been recommended by the National Institute for Health Care and Research (NICE) for treating bone disease after menopause.
More than 14,000...
Europe – EMA guidance document on the use of medicinal products for treatment in...
In 2003, at the request of the Directorate General Enterprise of the European Commission, the EMA published a guidance document on the use of...
International – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...
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...
