The latest trial over Actos' bladder-cancer risks is set to begin. With thousands of other Actos cases pending against Takeda, the case already was destined to be closely watched. And now, one of the plaintiff's lawyers says he's planning to seek the largest verdict in Nevada history.
Japan's health ministry is one of the world's toughest when it comes to demanding truth in advertising. The newest target of its scrutiny is Takeda Pharmaceutical, which is now admitting it may have mis-marketed its hypertension drug Blopress. Takeda's CEO, Yasuchika Hasegawa, told reporters at a news conference on Monday that the company used "inappropriate expressions" to advertise the drug, according to The Wall Street Journal.
Biopharma's long-heralded return to R&D ROI may come up short this year, according to EvaluatePharma, and the next class of approved drugs features fewer blockbusters in waiting than in any of the previous four years.
The National Institutes of Health has persuaded 10 rival drugmakers to briefly set aside their competitive spirits and collaborate on drug discovery projects in four major diseases, pooling their data and expertise to kick-start early-stage efforts.
Astellas presented summary results from Phase III trials of the Protein Sciences' flu shot it plans to commercialize in Japan. Separately, Takeda signed a deal to begin selling a freeze-dried live attenuated chickenpox vaccine in Japan.
Takeda has suffered a major setback in its quest to fill the blockbuster gap left by last year's loss of patent protection for the diabetes drug Actos. The pharma company reported that it was forced to scrap its late-stage program for the pioneering GPR40 agonist TAK-875, or fasiglifam, after trial monitors picked up clear signs of liver toxicity in patients.
After a touch-and-go review from FDA staff, Takeda's inflammatory bowel disease drug had an easier time convincing an agency advisory panel of its safety and efficacy. But while an FDA committee took little issue with vedolizumab's risk profile, Takeda may have a hard time convincing regulators to make its treatment an early option for patients.
FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.
Japanese drugmaker Takeda Pharmaceuticals saw an era end last year when generic versions of its top seller, diabetes drug Actos, hit the market. Now it is trying to usher in a bold new era by giving a non-Japanese executive a shot at being CEO at a particularly difficult time.
Carrying out a $1 billion cost-cutting program is easier if you're a stranger. That's the view of Takeda Pharmaceutical CFO François-Xavier Roger, who stepped into his role in September and took up the mantle of efficiency czar.