Bayer is on a roll. Just days after nabbing a speedy FDA approval of its cancer drug Stivarga (regorafenib), Bayer says it has nailed positive Phase III data on its new drug for rare cases of pulmonary arterial hypertension, which sets up an NDA that leave Bayer slugging it out with Actelion and Gilead for market share in 2014.
Poor Lamberto Andreotti. Just a year ago, the Bristol-Myers Squibb ($BMY) CEO was accepting bouquets for his company's better-than-the-rest reputation in Big Pharma. Now, he's nominated as the year's worst CEO.
The biotech's lead therapy, now in late-stage development, is aimed at eliminating chin fat. That may not be a big unmet medical need in the pharma world, but investors saw a big upside on demand if the drug can win approval.
Bayer has joined forces with Germany's Evotec on a new partnership aimed at a trio of new drugs for endometriosis.
Fast track indeed. Only three months after granting accelerated-approval status to Bayer's blockbuster hopeful regorafenib, a treatment for colorectal cancer, FDA gave the drug its final blessing.
Three months after landing FDA fast-track review status for regorafenib , Bayer 's top cancer prospect, today the agency delivered an approval as a treatment for colorectal cancer . The approval comes after a tumultuous lawsuit filed in 2009 by Onyx Pharmaceuticals ( $ONXX ), claiming the compound can be distinguished from Nexavar by only a single atom. Here's a look back at regorafenib's history.
Only three months after nabbing FDA fast-track review status for regorafenib, Bayer's top cancer prospect, the agency handed out a speedy approval this afternoon as a new treatment for metastatic colorectal cancer. The double-quick regulatory OK completes Bayer's quick sprint through the late-stage development process, paving the way to commercialization work expected to generate peak sales of $1.25 billion a year or more.
In a Phase III trial of Agile Therapeutics' combination contraceptive patch, AG200-15, women were much less likely to miss days of contraception with the patch than with the birth control pill.
Bayer, already one of the biggest players in the $8 billion a year contraceptive drug market, is aiming to take on Johnson & Johnson ($JNJ) in Europe with a transparent birth control patch.
Penny-pinching governments have put pharma's head in a vise, Bayer CEO Marijn Dekkers says. Joining a chorus of pharma executives, Dekkers warned that continuing to squeeze drug prices will crush innovation and drain the lifeblood from the R&D-based business model.