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.
Bayer is warning that its 2013 profits goals look a bit too ambitious now, but thanks to unexpectedly strong new-drug sales, it expects pharma revenue to jump by a high single-digit percentage. In fact, it hiked its forecast for sales from its newest products by 40%.
The company not only finally managed to make the IPO leap, it joined a select few which have priced their shares above the range, boosting their take and proving once again that the IPO door has swung wide open and the welcome mat is out--for now. The company sold 4.8 million shares at $17, above the $14 to $16 shares range laid out earlier. The offering raised $82 million.
Onyx Pharmaceuticals doesn't want to sell itself to Amgen for $120 a share. But it would sell out to a bidder with the right offer. The cancer-drug developer says it's entertaining shoppers, expecting a price tag markedly higher than Amgen's $10 billion.