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The FDA has approved a new indication for Roche’s Actemra to treat adults with moderately to severely active rheumatoid arthritis (RA) who have responded poorly to one or more disease-modifying anti-rheumatic drugs (DMARD).
The NIH is launching an online database of about 700 prescription and OTC drugs that will automatically forward cases of drug-induced liver damage to the FDA’s MedWatch adverse event reporting program.
Developers of acute heart failure drugs should conduct double-blind, randomized Phase III trials with co-primary endpoints, rather than composite endpoints, according to a draft European Medicines Agency (EMA) guideline.
Eli Lilly is trumpeting positive Phase III results for gastric cancer drug ramucirumab as investors upgrade expectations on the treatment’s profitability.
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