FDAnews Drug Daily Bulletin

Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker.

While congressional lawmakers continue to look for a last-minute means of advancing a federal track-and-trace system for pharmaceuticals, California continues to prep its ePedigree law for implementation in 2015.

The country’s highest court is likely to mull Hatch-Waxman’s safe-harbor provision now that the U.S. Court of Appeals for the Federal Circuit has issued contradictory rulings on when the law allows drugmakers to use others’ patents without fear of infringement.

The Federal Circuit partially revived Santarus’ bid to block Par Pharmaceutical’s generic version of the heartburn drug Zegerid (omeprazole/sodium bicarbonate), reversing a lower court’s ruling that claims of two patents governing the drugs’ absorption were invalidated by obviousness.

China Sky One Medical and its top executives have been sued by the SEC over claims they inflated revenue by about $20 million with fake sales of a weight-loss product.

Salix Pharmaceuticals said the FDA would take more time to review the drugmaker’s new treatment for HIV-related diarrhea and it now expects a regulatory decision by the end of the first quarter of 2013.

Bayer HealthCare’s consumer care division has launched a new OTC medication, Bayer Migraine Formula, to help patients suffering with devastating pain of migraine.

Valeant Pharmaceuticals’ $2.6 billion agreement to buy skin-care company Medicis Pharmaceutical recharges an acquisition plan that stumbled with last year’s failed bid for Cephalon.

The Harbin Pharmaceutical Group, a major pharmaceutical company in Northeast China's Heilongjiang province, has decided to relocate one of its plants from downtown Harbin to the city’s outskirts following a pollution scandal that occurred last year.