Japanese drugmaker Daiichi Sankyo will pay the $39 million to the state and federal health programs, and a whislteblower, to settle claims it paid doctors kickbacks to prescribe some of its drugs, Reuters reports.
What's long been a three-horse race just gained a fourth horse with the FDA's green light for Daiichi Sankyo's clot-fighter Savaysa. With the FDA's Thursday blessing, the drug will now face down a new-age anticoagulant trifecta that's been duking it out in the marketplace for a while now.
The FDA signed off on Daiichi Sankyo's clot-preventing edoxaban, giving the Japanese drugmaker the green light to compete in a crowded market for next-generation anticoagulants.
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.