FDAnews Drug Daily Bulletin
Nov. 5, 2012 | Vol. 9 No. 217
Rep. Ed Markey (D-Mass.) plans to introduce a bill that would force larger-volume compounders to register with the FDA as drug manufacturers.
Watson plans to immediately begin shipping its generic versions of Sanofi’s hypertension treatment Avapro after receiving FDA approval to market the generic version.
The FDA has given $2.7 million to University of Cincinnati researchers to study whether generic versions of the transplant drug Prograf have the same efficacy as Astellas Pharma’s branded product.
Portola Pharmaceutical, Bristol-Myers Squibb Company and Pfizer have signed a clinical collaboration agreement to study a universal Factor Xa inhibitor antidote, PRT4445, and Eliquis (apixaban).
Johnson & Johnson settled lawsuits with about 845 plaintiffs who claimed the drugmaker didn’t properly warn of the risks of tendon damage from its antibiotic Levaquin (levofloxacin).
Two new drugs for skin cancer have been recommended for use on Britain’s state-run health service after the rival manufacturers — Roche and Bristol-Myers Squibb — agreed to cut their prices.
Soon, glaucoma patients may see relief from a single daily eye drop. Aerie Pharmaceuticals has announced positive top-line results for a Phase IIa study of its new glaucoma treatment — one that uses a once-daily dosage instead of multiple eye drops a day like current treatments.
A Connecticut federal jury handed down a more than $48.5 million verdict in favor of Enzo Biochem, finding that Applied Biosystems infringed its patent relating to labeling and detection methods for DNA and other nucleic acids.
Mexico is keen on investments from Indian pharmaceuticals and IT companies so that bi-lateral trade achieves the $10-billion mark by 2015 from the current level of $4 billion, said Ashank Desai, Founder of Mastek.
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