USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
Fewer than one-third of molecularly targeted cancer drugs recently approved by the US Food and Drug Administration (FDA) meet established European benchmarks for clinical...
France – Les contre-indications à la vaccination contre le Covid-19
Les cas de contre-indication médicale faisant obstacle à la vaccination contre le Covid-19 et permettant la délivrance du certificat de contre-indication permettant de déroger...
USA – FDA modernizing pharmacovigilance oversight with AI tools
To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to...
USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
USA – Industry groups seek changes to FDA’s remote interactive evaluation guidance
Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration’s (FDA) approach for conducting remote interactive evaluations (RIE)...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC
The treatment recommendation is specifically for eligible adults for whom surgery or radiation treatment is not appropriate. NICE’s decision means eligible patients will be...
Europe – Guidance for industry to prevent and mitigate medicine shortages
EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .
Medicine...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
