FDA approved orphan drug Larium (mefloquine) May 2 for treatment and prevention of two resistant strains of malaria. The 250 mg oral tablets, which will be available in three to six months, are indicated for infections with two parasites, Plasmodium falciparum (including those resistant to other antimalarials) and Plasmodium vivax. The U.S. Army's Walter Reed Institute invented the compound. Development and testing was conducted by both the Army and Roche; both have NDAs, but Roche will be the sole manufacturer. It has been approved in 11 other countries.
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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.’
FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
