Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome--an indication the FDA has denied it on three separate occasions. But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.
Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.
Johnson & Johnson is riding the tailwinds of recent success, celebrating positive third quarter earnings buoyed by record-setting sales of its top products and the sell-off of its Ortho-Clinical Diagnostics business.
Johnson & Johnson and Bayer's Xarelto already heads up the pack of new-age anticoagulants, but the pair isn't quitting while it's ahead. Instead, the drugmakers are looking to expand that market lead with new clinical trials aimed at widening the drug's label.
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.