As European regulators this week consider whether to fast-track the eventual regulatory review of Jazz Pharmaceuticals’ treatment for acute myeloid leukemia, the company says it is on track to file for EU regulatory approval this year.
Jazz Pharmaceuticals, which should find out soon whether the European Medicines Agency will grant its acute myeloid leukemia (AML) treatment Vyxeos accelerated assessment, is on track to file the EU marketing application for the product this year.
Jazz, which secured US marketing approval for Vyxeos (cytarabine, daunorubicin) following priority review last month, plans to file for European...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
