Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
When an FDA expert panel recommended against a stronger form of hydrocodone from Zogenix ($ZGNX) this month, it said it was best if the FDA would first consider requiring ways to discourage abuse of opioids. The agency intends to do just that.
After its pain drug was shot down in a lopsided vote among FDA experts on Friday and analysts weighed in with a dour assessment of its chances at the hands of regulators, investors exacted their revenge on Zogenix today by wiping out half of the company's share price.
There is abuse of power and then there is power over abuse and that is what an FDA panel exercised Friday when they recommended against a stronger form of hydrocodone from Zogenix ($ZGNX), citing its potential for illegal use by drug addicts.
San Diego's Zogenix has taken another step in expanding its DosePro needle-free delivery system, signing a co-promotion agreement with Mallinckrodt, a division of Covidien.
The FDA wants to look over painkillers that include the ingredient known as hydrocodone amid an increase in abuse and federal drug agents' ongoing call for stricter prescribing guidelines, Bloomberg reported.
Zogenix has filed an investigational new drug application with the FDA for Relday, a schizophrenia treatment that uses the company's DosePro drug delivery tech.
The company has wasted little time finding another marketing partner, inking a one-year deal with Battelle to promote the needle-free platform.
Zogenix announced that its chronic pain drug had aced a late-stage study, putting it on track for a marketing application in early 2012. But the news did little for its share price ( $ZGNX ), which has
Durect has bounced back some from a regulatory setback last month with a brand new pact with developer Zogenix. The two companies struck a deal to develop a long-acting version of the antipsychotic