Vivus has never had a marketing partner for flailing obesity therapy Qsymia--and now, it's about to be one short for erectile dysfunction therapy Stendra, too. Last week, Endo's Auxilium Pharmaceuticals announced in a regulatory filing that it would be terminating its licensing pact--covering the U.S. and Canada--with the California drugmaker, with an end date of June 30.
The FDA has cited two of Endo's units in its latest enforcement report, calling for separate recalls of two drugs.
What is a drugmaker's responsibility when a packaging problem results in an unplanned pregnancy and the consumer is looking for financial support for raising a child they weren't prepared to have? That is what more than 100 women intend to discern with suits against Endo Health Solutions and Patheon.
Opioid makers thought they had dodged a litigation bullet 6 months ago when a federal judge dismissed a lawsuit by the City of Chicago trying to hold them accountable for an "epidemic" of painkiller, and even heroin, abuse. But the city is being tenacious and has refiled lawsuits claiming 6 drugmakers overstated the claims of the drugs' benefits while downplaying their risks.
Endo and BioDelivery Sciences International announced FDA approval of Belbuca, the first and only polymer strip for the delivery of the painkiller buprenorphine from the inside of the cheek.
Endo's Alabama plant where its Qualitest unit makes generics is recalling a couple of drugs, some for being outsized and off-color.
A couple of years ago, Endo decided to put a bunch of money into its Alabama plant where its Qualitest unit makes generics. But that facility has recently been tripped up by some manufacturing issues and is now recalling a couple of drugs, some for being outsized and off color.
Former Endo sales rep Peggy Ryan first filed a whistleblower suit--concerning off-label marketing of its pain patch, Lidoderm--against the drugmaker in 2005. Nine years later, the company settled with the Department of Justice. And now, Ryan is walking away with a hefty chunk of change.
Endo and Mallinckrodt have both been using M&A to help them head down the specialty pharma path. Both call Ireland home, helping them boast lower tax rates than many of their peers--and giving them a leg up in the dealmaking arena. And both generate the vast majority of their revenue in the U.S. But as Moody's points out, there are some important differences between them, too--and those will help determine their next M&A moves.
The Centers for Disease Control and Prevention says that a formulation of Endo's pain med, Opana ER--that's supposed to be difficult to crush--is responsible for an outbreak of HIV in southern Indiana, because the changes made it easier to prepare the drug for more dangerous intravenous or subcutaneous injection.