Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.
Blood thinner Xarelto and eye med Eylea pack a pretty good one-two-punch. Those new drugs helped Bayer's pharma sales climb 9.4% in 2013, and they're not stopping: They'll ultimately lead a group of 5 recently launched products to sales of €7.5 billion ($10.3 billion) or more, CEO Marijn Dekkers said Friday.
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.
A panel of FDA advisers voted 10-0 against recommending that Johnson & Johnson's Xarelto be approved to treat patients with acute coronary syndrome, marking the third such rejection for the treatment.
An FDA advisory panel left no room for interpretation Thursday as to whether it thought the FDA should approve Johnson & Johnson's Xarelto as a treatment for acute coronary syndrome, delivering its "no" loud and clear at the end of the daylong hearing.
The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
Eye drug Eylea and blood thinner Xarelto are pretty good products for any drugmaker to have in its lineup, and Bayer's got them both. Sales of those new stars have been plentiful, and they helped the German company raise earnings 7.7% for the third quarter, the company announced Thursday.
The Institute for Safe Medication Practices has flagged its latest set of side-effect reports to the FDA--and once again, anticoagulant drugs are at the top. Boehringer Ingelheim's Pradaxa, a new-generation pill, and the old standard therapy warfarin together accounted for more than 1,100 of the adverse events reported direcctly to the FDA.
Herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge--one we weren't exactly expecting, based on previous experience. Read the full report >>
German regulators have responded to Der Spiegel 's questions about Xarelto side effects. Answer? The Federal Institute for Drugs and Medical Devices sees no new red flags for patients using the clot-fighting drug developed by Bayer and Johnson & Johnson.