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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 rejected Repros Therapeutics’ NDA for its secondary hypogonadism treatment enclomiphene, asking the drugmaker to conduct an additional Phase 3 study or studies, as the original trials are no longer adequate to demonstrate clinical benefit. Read More
The nation’s largest pharmacy benefits manager is throwing its support behind a cheaper alternative to Turing Pharmaceuticals’ expensive toxoplasmosis/HIV treatment, threatening its monopoly on the market. 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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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
In a win for drugmakers, President Barack Obama signed into law a bill that extends exclusivity periods for new drugs and biologics containing a controlled substance by changing the date they are considered to have been approved from the current FDA sign-off to when the Drug Enforcement Agency schedules them for sale. 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