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.’
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
