It is not easy for companies to convince the European Medicines Agency that their marketing applications merit accelerated assessment. Four new hopefuls are about to find out whether they have been successful.
NovImmune, AveXis, bluebird bio,and Loxo Oncologyare all close to filing for potential approval in the EU investigational therapies that they hope will be fast-tracked through the system.
The products include two gene therapies: onasemnogeneabeparvovec (AveXis, recently acquired by Novartis) and LentiGlobin (bluebird bio). The other two...
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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.
