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Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More
Japanese drugmaker Eisai’s U.S. subsidiary is selling and assigning its U.S., Canadian and Japanese development and marketing rights to Dacogen to Otsuka Pharmaceuticals. Read More
The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More
GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More