After a spirited debate over some missing study data, the advisory committee refused to back a big new use for the blood thinner. Between absent data on about 1,000 patients who withdrew from the trial and worries about its bleeding risks, Xarelto's bid for an expanded market went down.
GlaxoSmithKline, Sanofi, AstraZeneca, J&J as well as Basilea will join an R&D consortium including Europe's Innovative Medicines Initiative to fund the effort, setting up an information hub that will share data among investigators laboring on new antibiotics.
The balloting turned against J&J after 6 of 10 outside experts concluded that the risk of bleeding and doubts about its pivotal data prevented them from endorsing an approval for preventing heart attacks and strokes among patients with heart problems.
The advisory panel is weighing evidence for a new, potentially lucrative use in patients with acute coronary syndrome.
Johnson & Johnson ($JNJ) has won a lawsuit against a long-time distribution partner in China. While the amount of money involved may seem puny, it appears to be a big victory in a country that is terribly protective of its domestic drug distributors.
The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.
We know how pharma CEO pay stacked up within the industry. But how did pharma's 2011 compensation packages compare with those in other industries?
The anticoagulant won a thumbs-up from FDA reviewers ahead of Wednesday's advisory panel meeting, where FDA experts will weigh a lucrative new indication.
Johnson & Johnson's McNeil Consumer Healthcare is retrieving a lot of Imodium--nearly 54,000 packages
A new study suggests Zytiga may be effective in early-stage disease. The small trial--it involved only 58 patients with localized, high-risk cancer--found that Zytiga wiped out or nearly wiped out tumors in one-third of them.