USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary...
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates...
UK – Illegal medicines worth more than £30 million seized in the UK in...
This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical...
International – Modular plug-and-produce facilities for cell therapies
At the start of 2021, a crane lifted a shrink-wrapped, elongated structure off a truck flatbed and through a window into an upper floor...
Europe – Two new advice pilots to improve clinical trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the...
International – ICH adopts S12 guideline for gene therapies
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached...
France – La HAS actualise la doctrine vaccinale de lutte contre les orthopoxvirus
Les orthopoxvirus constituent une famille de virus à laquelle appartiennent la variole, mais aussi la vaccine et le mpox (nouveau nom du virus monkeypox). Comme...
France – Vaccination contre le Covid-19 et maternité
La vaccination est un acte médical. Elle repose sur deux piliers :
Le respect des dispositions générales du code de la santé publique concernant l’information...
USA – Uptake of biosimilars on the rise in the US, but number of...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...
