Astellas is tasked with introducing a new product into the already crowded overactive bladder market now that it has gained approval for the beta-3 antagonist mirabegron in the U.S.
After several hurdles related to safety concerns, Astellas Pharma Inc. has won FDA approval of its overactive bladder medication Myrbetriq (mirabegron) but now must overcome the hurdles related to launching a new drug into an already crowded marketplace with low-cost generic competition.
FDA okayed the drug June 28, on the eve of its user fee action date, for overactive bladder with symptoms...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
