The $6.5 million jury verdict in Takeda Pharmaceuticals' first Actos trial didn't last long. Judge Kenneth Freeman tossed out the jury's judgment, saying that plaintiffs' lawyers didn't prove that Jack Cooper's bladder cancer was linked to his use of Actos.
Score one for the plaintiffs in Takeda Pharmaceuticals' Actos litigation. A California jury weighed in against the drugmaker, deciding that Takeda didn't do enough to warn patient Jack Cooper about a heightened risk of bladder cancer.
Actos and its potential links to bladder cancer are now on trial. And already, lawyers have brought out incriminating emails, in which Takeda Pharmaceutical executives discuss damage-control plans. It's the first case pitting a patient with bladder cancer against Japan's Takeda, which built Actos into a $4.5 billion product before safety questions took hold. The company faces at least 3,000 similar claims.
The first trial of a lawsuit linking the diabetes drug Actos with bladder cancer is about to begin. As Bloomberg reports, jury selection starts today in Los Angeles, as Takeda Pharmaceuticals gears up to fight more than 3,000 claims from patients who used the diabetes drug.
Takeda Pharmaceutical last week nailed down FDA approval for three new diabetes drugs--DPP-4 inhibitors--and it was none too soon, as today's earnings report makes crystal clear.
Takeda has finally won FDA approval for its new diabetes franchise, which revolves around the active ingredient alogliptin. But the triumvurate of new DPP-4 inhibitors--including the straight alogliptin Nesina and two combination pills--face some formidable rivals.
The FDA stamped approvals on three diabetes drugs containing the active ingredient in Takeda Pharmaceutical's Nesina.
Watson Pharmaceuticals ($WPI) has been vindicated in its fight for the right to sell an Actos generic. A U.S. judge ordered FDA to approve Watson's version of the Takeda Pharmaceutical diabetes drug, slapping aside the agency's move to bar Watson during the first six months of generic availability.
Does FDA have a special obligation to patients who sign up for post-marketing safety studies? An article in the latest New England Journal of Medicine suggests it does. And with new legislation setting up the prospect of more fast-track approvals, the authors point out, post-marketing studies will be more common--and more important--than ever.
It's not a megabrand like Lipitor or Plavix, but the diabetes drug Actos has brought in more than $3 billion in U.S. sales at its peak, more than $16 billion total since its release in 1999. And now, it has generic competition. Takeda Pharmaceuticals, watch your back.