Novimmune and Biogen encountered surprises, challenges and opportunities with PRIME, the European Medicines Agency’s new priority medicines scheme. The two companies have some advice on how to keep pace with expectations under the initiative and make the most of the scheme for taking drugs for unmet medical needs to patients faster.
Novimmune met the invitation earlier this year to attend a kick-off meeting with the European Medicines Agency under the regulator’s new priority medicines (PRIME) scheme with some trepidation.
“It came as a surprise to us that we got to see the EMA so quickly,” Novimmune’s Chief Medical Officer,...
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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.
