Bayer scored another R&D success with the FDA approval of Adempas (riociguat) for two rare pulmonary disorders. But with a rival drug candidate breathing down its neck, Bayer will have to carve out a place in that market quickly.
Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new approval of riociguat--to be sold as Adempas--for a devastating lung disease.
Over the past two years Bayer has snagged an impressive string of key approvals for cancer and cardiovascular drugs--a much better record than many of its larger Big Pharma rivals. And today the pharma player is rolling out its slate of the next top drug prospects being groomed for late-stage pipeline work.
Brandicourt will assume the top job at Bayer HealthCare Nov. 1, taking over the reins from executive Wolfgang Plischke, who has been running the unit while the company found a new leader.
Friday, the EU's Committee for Medicinal Products for Human Use (CHMP) recommended 11 new drugs for a variety of diseases--the most nods it's given in a single meeting all year.
Add Bayer to the list of companies Chinese authorities are investigating. Friday, a Bayer spokeswoman told The Wall Street Journal China's probe has reached the German pharma for a "potential case of unfair competition" as the country's government continues its industry-wide crackdown.
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.
The number of side-effect reports on Bayer's anticoagulant drug Xarelto appears to be increasing, and some doctors are growing wary of using the drug as a standard first-line treatment, the German newspaper Der Speigel reports.
The European Commission has stamped an approval on Stivarga (a.k.a. regorafenib) for aggressive cases of colorectal cancer, marking a regulatory victory for Bayer Healthcare and Onyx Pharmaceuticals ($ONXX). Amgen ($AMGN) benefits, too.
Stivarga, the cancer drug that Bayer developed with Onyx Pharmaceuticals, has nabbed yet another approval, this time in Europe, as it rolls toward its anticipated blockbuster status.