A growing buzz about potential safety issues has raised a cloud of doubt about Merck's osteoporosis drug odanacatib, which is likely to linger now that the pharma giant has released Phase III results and laid out plans for a delayed FDA filing.
Merck is in a world of hurt. The pharma giant managed to spook several analysts with the news that its osteoporosis drug odanacatib would be held back from regulators until more data could be obtained in a trial extension, raising fears that the badly needed drug may be about to jump the tracks.
Merck's R&D division has been hit with another setback. The pharma giant--which consistently spends more than $8 billion a year on drug research--announced in its fourth-quarter report that an expected regulatory submission for its osteoporosis drug odanacatib is being held back in order to gather more safety and efficacy data from a Phase III extension study.
Merck says it nailed the positive Phase III data it needs to gain an approval on the late-stage osteoporosis drug odanacatib, allowing investigators to start wrapping up the big global study and accelerating the timeline on the potential blockbuster.
Merck has touted the performance of one of its late-stage contenders as the drug giant readies an application for U.S. approval of the experimental insomnia drug.
Merck today says it has the late-stage data it needs to gain an approval for a new insomnia drug, one of 5 treatments the pharma giant believes it can gain an official OK on before the end of 2013....