Novartis Evaluates Collaboration To Develop Treatments For Complex Liver Disease

The Wall Street Journal: Novartis Doesn’t Rule Out Further Deals In NASH Treatments
Novartis AG can’t rule out striking more collaboration deals or acquisitions to develop effective treatments against a complex liver disease known as NASH, a company executive said Thursday, as drug giants race for dominion in an untapped disease area that could rake in billions of dollars in revenue. There are currently no approved drugs for NASH, or nonalcoholic steatohepatitis, a progressive liver disease that affects about 5 percent of the global population. The disease is expected to become the leading cause of liver transplants in the U.S. by 2020. The market is expected to balloon to $18.3 billion in 2026 from $138.4 million in 2016, according to analytics company GlobalData. And that’s only for the world’s seven major markets, or the U.S. Germany, France, Italy, Spain, the U.K. and Japan. (Mancini, 4/11)

Stat: FDA Chastises Addyi Maker Over Trying To Remove Alcohol Safety Warning
Four years after approving the controversial Addyi pill for female sexual dysfunction, the Food and Drug Administration on Thursday softened a safety warning about mixing the drug with alcohol. But the agency also rebuked the manufacturer for insisting that the warning should be removed altogether, and took this unusual step after finding shortcomings in required post-marketing studies. The FDA action is a mixed decision for Sprout Pharmaceuticals, which sought to revive Addyi sales by dispelling lingering long-running safety concerns over interactions with alcohol. The agency insisted that removing the warning entirely “was not acceptable for the protection of public health.” We asked Sprout for comment and will update you accordingly. (Silverman, 4/11)