Marathon Rotary Club

Wednesday, 12:15pm Meeting at the Marathon Yacht Club

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Start of generic AXERT tabletsHutchison MediPharma starts sulfatinib Phase I trial in USMylan announces U.S. Launch of generic Fusilev for InjectionAt the getting together with, the FDA agreed that the proposed NDA for Northera could possibly be submitted predicated on mixed data from Chelsea’s two finished Stage III research in NOH, Study 301 and Study 302, with no need for any further efficacy studies. Through the meeting, the agency did request and Chelsea decided to supply top-line outcomes from a QTc study at the time of the 90-day Protection Update and conduct a post-marketing study to evaluate the medical pharmacology of Northera in renally impaired individuals. ‘The successful result of our pre-NDA meeting with the FDA reflects the strength of the data already generated by our pivotal program and marks a substantial step of progress for Chelsea,’ commented Dr.