Bristol-Myers Squibb has won yet another approval for its pioneering immuno-oncology drug Opdivo. The regulatory nod in advanced renal cell carcinoma, a form of kidney cancer, comes just one week after the FDA accepted the filing for priority review.
In another striking FDA turnaround for Bristol-Myers Squibb's Opdivo, the agency has approved it for treating advanced renal cell carcinoma just a week after granting priority review.
The FDA has approved Takeda Pharmaceutical's Ninlaro, a treatment for multiple myeloma that the Japanese company hopes can get established before its blockbuster Velcade loses patent protection.
Novartis has been jockeying for additional uses for its next-gen psoriasis med, Cosentyx, hoping that a trifecta of indications will help generate blockbuster sales and distinguish the drug from its competition in a hot market. Now the med is moving one step closer toward achieving its blockbuster aspirations with an EU nod to treat patients with psoriatic arthritis and ankylosing spondylitis.
India's efforts to smooth over trade disputes with the European Union will lead to a resumption of bilateral talks early next year, but GVK Biosciences will have to be satisfied with watching from the sidelines.
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.
South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use.
China is moving on several fronts to make it easier and safer for potential patients to use the nation's expanding healthcare system, with a new emphasis on drug regulations, devices and elderly care. Even so, American drugmakers say the government should do even more in the drugs area.
The regulator, which has faced criticism in the past over its failure to establish a policy, set out its position in a 12-page document.
Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success of Velcade.