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"This patent significantly expands the strength of the VIMOVO patent estate and extends patent protection out to 2031," said Timothy P. Walbert, chairman, president and chief executive officer,

Teflaro is designed to treat acute ABSSSI caused by susceptible bacterial isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella

The submission is part of the company’s ATX-101 global development program and follows regulatory applications in the US, Canada and Switzerland. In Australia, the regulatory application was supported

An independent data monitoring committee determined that the open-label, multicenter, randomized two-arm trial met its primary endpoint early. Roche chief medical officer and head of Global Product Development

For the sNDA, the anticipated Prescription Drug User Fee Act (PDUFA) action date will be in October 2015. The submission of sNDA was based on data from a

Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone

The acquisition will build on Mylan’s existing partnerships with Famy Care in North America, Europe and Australia, and provide Mylan with an enhanced and now vertically integrated platform

The drug is indicated to treat patients with STS, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. STS are a type of cancer

These are in addition to multiple other patents that have been issued and granted in the United States, Mexico and Australia for ophthalmic administration of voclosporin. Further patent