The so-called 21st Century Cures Act, now making its way through Congress, is designed to speed up the FDA review process for potentially lifesaving medicines by encouraging approvals based on midstage data. But a new case study takes a look at what might have happened if a trio of once-promising Alzheimer's drugs had made it to market before their eventual Phase III failures, painting a grim picture of the bill's potential.
Adapt Pharma's Narcan nasal spray became the first noninjectable treatment for opioid overdose emergencies thanks to its FDA approval on Nov. 19.
As with most corporate chiefs, Biocon's normally would be pleased with India's proposal to lower the nation's corporate tax rate to 25% from 30%. But, if it means eliminating tax exemptions for investments in research and development, Biocon is opposed.
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.