Japan's Takeda Pharmaceutical won early U.S. Food and Drug Administration approval for ixazomib (Ninlaro) to treat multiple myeloma ahead of its scheduled PDUFA review in March next year, the company said in a press release.
One of Takeda's experimental cancer therapies has been tested in a small group of advanced lymphoma patients, offering a snapshot of "modest" efficacy that could be amplified in earlier stage patients and in combination with other drugs.
Japan's Takeda Pharmaceutical has crossed a threshold for the settlement of thousands of lawsuits tied to bladder cancer risks from its diabetes drug Actos, triggering a payment of more than $2 billion, the company said in a release.
Two dengue treatment options are slated for Phase II trials in Singapore next year as efforts to get vaccines by Sanofi and Takeda Pharmaceutical to the market also gather steam.
Japan's R-Tech Ueno, which faced a clinical setback this year in ophthalmology even as it sought wider opportunities in the area, has seen U.S.-based Sucampo launch a tender for the firm valued at $278 million overall after the founders agreed to sell their holdings.
Japan's Takeda Pharmaceutical has submitted a second post-marketing study to regulators in the United States, Europe and Japan that it says shows no increased risk of bladder cancer in patients treated with Actos (pioglitazone) in a key milestone following its April decision to settle thousands of lawsuits related to the diabetes drug.
Takeda Pharmaceutical Chairman Yasuchika Hasegawa was removed as vice president by the Japan Pharmaceutical Manufacturers Association, according to an updated leadership list that was confirmed by a company spokesman.
Takeda Pharmaceutical was sanctioned by Japan's Ministry of Health, Labor and Welfare for using exaggerated marketing materials to promote hypertension medicine Blopress and was issued a business improvement order with which it will comply, according to a June 12 press release from the company.
Takeda Pharmaceutical has consolidated vaccine offices, signed a slew of alliances for discovery efforts and moved aggressively to refocus the company since Christophe Weber took over as CEO on April 1.
A move by Takeda Pharmaceutical to consolidate its Vaccine Business Unit into hubs should allow sharper focus on a complex set of vaccine programs covering norovirus, dengue and seasonal influenza in an increasingly competitive global horse race.