Latest Headlines

Latest Headlines

Novartis balks at Eylea-vs.-Lucentis data

Bayer and Regeneron ($REGN) are touting new data on their macular degeneration drug Eylea. And no wonder: The VIEW 1 and VIEW 2 studies found that Eylea matched rival drug Lucentis in head-to-head comparisons.

Bayer nails promising PhIII results for new PAH contender riociguat

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.

Does Bristol's tarnished rep put CEO among the year's worst?

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.

Investors back $70M IPO for Kythera

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, Evotec join forces on $765M endometriosis drug partnership

Bayer has joined forces with Germany's Evotec on a new partnership aimed at a trio of new drugs for endometriosis.

Bayer cancer drug races through FDA approval

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.

Timeline on regorafenib (Stivarga) development

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.

UPDATED: Bayer, Onyx nab speedy FDA OK for regorafenib, prices at $9,350

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.

Patch improves birth control compliance

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 takes aim at J&J's Evra with new birth control patch

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.