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.
Bayer's Eylea has a new field for fighting Lucentis. The eye drug won a new approval in Europe, in patients with macular degeneration due to central retinal vein occlusion, setting it up for another market-share battle against Novartis.
Bayer's Nexavar is one big step closer to a thyroid-cancer approval. The FDA put the drug on the priority-review fast track, which means Nexavar could have its new indication by February. It's a timely win for Bayer's development partner, Onyx Pharmaceuticals, which just agreed to a $10.4 billion buyout by Amgen.
Japanese regulators have cleared Bayer's cancer drug Stivarga for a new use, against gastrointestinal stromal tumors. It's just the latest victory for the fast-tracked drug, developed with U.S.-based Onyx Pharmaceuticals.
An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma giant on what appears to be another victory lap in the lead-up to a likely approval.
Bayer said two late-stage tests for Eylea against diabetic macular edema met their primary goals of improving vision compared with laser surgery, meaning that co-developer Regeneron can now submit an application for U.S. marketing approval for that indication later this year--about a year earlier than planned.
Shares of Israel's Compugen soared more than 60% this morning after the Israeli biotech signed on to a collaboration with Bayer to find new antibody-based cancer immunotherapies.
Tel Aviv, Israel-based Compugen said that the license agreement with Bayer centers on its discovery of two so-called checkpoint regulators, which serve as targets for antibody drugs.
Bayer garnered support from FDA staff for its submission for approval of riociguat for two forms of pulmonary hypertension, though reviewers recommended clearing the experimental drug at a lower dose than the company sought.