The inevitable has happened for Bayer's fast-selling anticoagulant blockbuster, Xarelto. Someone in the U.S. has filed a lawsuit over its safety concerns. In fact, a number of lawsuits have been filed, according to reports in a German newspaper.
It turns out that Boehringer Ingelheim's popular anticoagulant Pradaxa is safer than many people think. That is the finding of the FDA after taking another look at the side effects of the drug compared to the old standard warfarin and this time looking at a much larger and older patient base.
Weak consumer sales and flat medical device and diagnostics sales didn't stop Johnson & Johnson from trouncing analyst estimates Monday--or from raising its guidance for the year. A lineup of hot new meds powered the drug giant's first-quarter performance, helping pharma sales climb nearly 11% to $7.5 billion.
Johnson & Johnson and Bayer's Xarelto made its way to the front of the new-age anticoagulant pack not long after hitting the U.S. market, gaining ground from rival Pradaxa to head what has since become a three-horse race. And that's ground its makers aren't ready to cede.
Boehringer Ingelheim, determined not to let clot-fighter Pradaxa be outdone by Bayer and Johnson & Johnson's Xarelto, has added a couple of new uses to the drug's label, snagging the FDA's okay to treat deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. But it still has a long way to go--and some safety concerns to dispel--before it can retake the anticoagulant throne.
The CEO of the German drugmaker is pinning some numbers on the medium term; the Big 5 will help Bayer aim for an average of 8% annual growth in its pharma unit through 2016, Marijn Dekkers said Wednesday.
Bayer knows what a good launch can do; with blood thinner Xarelto and eye drug Eylea, it's had a couple of the recent best. Thanks to that pair of hot-selling meds, the German pharma raised the sales forecast for its new products by €2 billion late last week--and it's raising its marketing budget along with it.
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.