The European Medicines Agency's experts have backed approval for two drugs that have already gained green lights for the U.S. market.
The FDA keeps offering up tough news to Johnson & Johnson for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome (ACS), and today the company said it had a complete response letter for use of the bloodthinner to prevent stent thrombosis in patients with ACS.
The U.K.'s cost-effectiveness watchdog gave final clearance to Bayer's anticoagulant drug Xarelto for use in preventing potentially fatal blood clots in the lungs and legs. Meanwhile, Boehringer Ingelheim was filing for European approval for its new-generation anticoagulant, Pradaxa, for similar uses.
Seattle Genetics, which has a who's who in oncology drug development signed on as ADC collaborators, gets $20 million of that upfront with the rest in milestones.
Bayer has wrapped up its $1.1 billion acquisition of Conceptus, adding the company's permanent birth control device to its flagging contraceptive business.
Bayer and Onyx appear poised to expand sales of Nexavar (sorafenib). Investigators told the crowd at ASCO Sunday morning that their therapy almost doubled progression-free survival of treatment-resistant thyroid cancer patients, from a median 5.8 months in the control arm to 10.8 months in the treatment group.
Bayer and Regeneron's hard-charging eye drug has traded its way to another victory. It won a recommendation from the U.K.'s cost-effectiveness watchdogs, on the strength of a pricing discount. Previously rejected as too expensive, Eylea is now in line for routine use by Britain's National Health Service.
French health regulators say they'll usher Bayer's hormonal pill Diane 35 back onto the market, if top European watchdogs ratify the latest recommendations from a drug-safety body.
As Bloomberg reports, Germany's Der Spiegel has ferreted more details about drug research in Soviet-era East Germany, where pharma groups tied to some of the biggest names in the industry reportedly benefited from cheap clinical trials before the fall of the Berlin Wall.
Bayer has a new set of upbeat results from its long-term extension study of riociguat, a major new player in a busy field of competitors angling for a share of the market for pulmonary arterial hypertension.