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The Department of Justice has netted $96 million from the pharmaceutical industry in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30. Read More
Amid increased scrutiny over drug pricing, Mylan has been hit with a subpoena from the antitrust division of the Department of Justice over pricing of its 50-year-old antibiotic doxycycline, the drugmaker revealed in an SEC filing. Read More
The UK’s pricing watchdog said it does not recommend reimbursement for Alexion’s Strensiq because it does not provide enough value for its high price. Read More
A recent report suggests the advisory committees that the FDA relies upon to ensure medical products are safe and effective can be wildly inconsistent in their recommended approval rates. Read More
A month after the FDA announced a nationwide sweep that resulted in criminal and civil cases against 89 makers of dietary supplements, a former owner and operator of a Montana dietary supplement maker has been sentenced to prison for selling supplements in violation of two court orders. Read More
An FDA advisory committee Tuesday erected another roadblock for getting Fabre-Kramer’s depression candidate gepirone on the market, recommending against approving a potential therapy whose fate has been in limbo for two decades. Read More
Gilead Sciences put profit over affordability when pricing its line of hepatitis C treatments, says a Senate Finance Committee report issued Tuesday. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
Fabre-Kramer Pharmaceutical’s depression candidate gepirone could be held back yet again in its fourth go-around, with the FDA questioning whether two successful trials are enough to prove its value alongside a “relatively large” number of negative trials. Read More