Arena Must Deal With Rat Neoplasms To Move Forward With Lorqess
A major task confronting Arena as it pursues approval of Lorqess is to provide FDA with an explanation that shows the neoplasms found in rats during animal studies of the obesity drug are not a predictor of cancer risk in humans.
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The Omniscient Regulator: QRxPharma’s Unusual Take on FDA and Investor Calls
Investor calls routinely begin with a disclaimer that the call is being recorded. They don’t usually include a warning that “FDA is monitoring the call.” But that is how QRxPharma began a discussion of a bad news event for its MoxDuo application.
Arena Finds Antidote For Belviq’s Theoretical Risk Of Valvulopathy In Mechanistic Studies
Additional preclinical studies provided FDA with reassurance during a second-cycle review that lorcaserin was unlikely to trigger the valvular heart disease associated with dexfenfluramine and fenfluramine.
Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients
The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals.