Oct. 4, 2012 | Vol. 11 No. 195 | Full Issue in PDF Format
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During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan.
Mylan is suing the FDA over its refusal to grant 180-day exclusivity for the company’s four generic versions of Novartis’ high blood pressure drug Diovan.
New fixed-dose drug combinations that include at least two INDs and target a serious or life-threatening disease could be eligible for an additional six months of marketing exclusivity and priority review under a new bipartisan-supported bill sponsored by Rep. Brian Bilbray (R-Calif.).
Daiichi Sankyo and ArQule are discontinuing a Phase III trial of tivantinib in combination with erlotinib for patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSLC).
Sponsors of treatments for acute bacterial otitis media (ABOM), an inflammation of the middle ear, may be able to use a single clinical trial to support an application under some circumstances, according to a final FDA guidance.
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