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A group of lawmakers wants the FDA to strip Zogenix’s opioid painkiller Zohydro ER of its approval until the company creates an abuse-deterrent formulation of the product. Read More
CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals is appealing to the courts to keep Gilead’s competing hepatitis C treatment off pharmacy shelves. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More
In an effort to head off one of the most common problems that sidetracks ANDA submissions, the FDA is telling drugmakers that bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel. Read More
The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More