Will the European Medicines Agency decide this week that Dova Pharmaceuticals’ eventual marketing authorization application for avatrombopag should be fast-tracked? If it does, the potential new thrombocytopenia therapy would join just a handful of products that are being reviewed under the EMA’s accelerated assessment pathway.
Dova Pharmaceuticals Inc. should find out this week whether its potential new thrombocytopenia therapy and lead drug candidate, avatrombopag, will be granted accelerated assessment when the company files for approval in the EU.
The initial indication for which avatrombopag is being developed is the treatment of thrombocytopenia in adult patients with chronic liver...
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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.
