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Sept. 6, 2012

Vol. 9 No. 175

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Impax Can Launch Generic Renvela, Renagel in 2014 Following Genzyme Settlement

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

As Congress Mulls Track and Trace, California Plows Ahead on ePedigree

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. Read More

High Court Likely to Keep ‘Safe Harbor’ Broad, Aiding Generics, Biosimilars

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. Read More

Fed. Circ. Revives Santarus’ Suit Over Par’s Generic Zegerid

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. Read More

Chinese Medical Firm Sued by SEC Over Phony Weight-Loss Product

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. Read More

FDA Delays Decision on Salix’s Diarrhea Drug

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. Read More

Bayer Launches New OTC Medication for Migraine Treatment

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

Valeant Revives Growth Plan With $2.6 Billion Medicis Deal

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. Read More

Pharmaceutical Plant to Relocate After Pollution Scandal

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. Read More