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The FDA should stop thinking just about benefits and risks in a product’s lifecycle and adopt a “net-benefits” approach, a contract research organization has urged the agency. Read More
The Drug Enforcement Administration has placed Sage Therapeutics’ recently-approved postpartum depression drug Zulresso (brexanolone) in Schedule IV of its controlled substances list. Read More
America’s towns and counties could be condensed into a single class to simplify the highly complex litigation against opioid drugmakers, a key plaintiff’s lawyer suggests. Read More
Amgen, Merck, Eli Lilly and the Association of National Advertisers have filed suit against HHS’ rule requiring drug companies to display list prices in TV ads, claiming the requirement will only sow confusion. Read More
“We cannot understand why Americans pay two to six times more than the rest of the world for brand name prescription drugs or why the U.S. comprised 42 percent of global pharmaceutical revenues…” the letter stated. Read More
A Dutch research institute believes oncology patients should be covered for treatments not intended for their type of cancer—if the off-label treatments work in trials—and it’s trying out performance-based payments. Read More