A panel of FDA advisers voted in favor of approving Daiichi Sankyo's irregular heartbeat treatment edoxaban, heralding its ability to break up blood clots and improving the company's odds of finally launching the drug in the U.S.
Daiichi Sankyo's campaign to win approval for its atrial fibrillation drug edoxaban gained some support from regulators at the FDA who were clearly won over by the efficacy data in the NDA. But the internal review of the drug also includes recommendations for limiting its use to patients with abnormal kidney function. And they include a few cautionary notes on the competing drugs that have already made it to the market.
Astellas may not have wanted Ambit Biosciences as a development partner, but fellow Japanese pharma Daiichi Sankyo wants it as an acquisition.
About 18 months after Astellas dumped its development partnership with Ambit Biosciences on a now late-stage drug for acute myeloid leukemia, Daiichi Sankyo has stepped in to snap up the San Diego-based biotech for up to $410 million. The deal helps beef up the Japanese company's oncology pipeline.
Daiichi Sankyo, Japan's second-largest pharma outfit, has agreed to pay up to $650 million to get its hands on some hydrocodone combo medications, striking a deal with Charleston Laboratories with hopes of cashing in on the demand for pain pills.
After four years of sifting data, the FDA says it found "no clear evidence" that Daiichi Sankyo's blockbuster blood pressure drug increased the risk of heart attack. But the agency will require new safety-related data on Benicar's official label.
One of the execs who masterminded Daiichi Sankyo's acquisition of Ranbaxy Laboratories--and then lived with it as the generic drugmaker drew the Japanese company into a whirlwind of regulatory issues--is stepping down as chairman.
In an effort to control costs, Japan's Daiichi Sankyo is reworking its manufacturing network and says that in Japan, it has even turned over some of its warehousing and logistics to another company.
Ranbaxy Laboratories continues to spend big as it tries to deal with regulatory issues at plants banned by the FDA, issues that pushed it into the arms of competitor Sun Pharmaceutical. The more than $20 million in write-downs on inventory and goodwill it had to take in the last quarter led to a loss, even as sales improved slightly.
Thanks to a steady flow of expensive new cancer therapies--and a public brouhaha over the cost of next-gen treatments for hepatitis C--drug prices are on center stage. We thought we'd look into the products whose prices have increased the most since 2007, to see how and why their prices are leaping.