ASTELLAS PHARMA US, INC.: Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia

Astellas Pharma Inc. announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). Read More »

MCKESSON, INC.: McKesson Board of Directors Releases Findings and Recommendations of Independent Investigation

The Board of Directors of McKesson today released its response to a request from the International Brotherhood of Teamsters, a McKesson stockholder, that the Board perform an investigation into senior management’s and the Board’s oversight of McKesson’s compliance with its legal and regulatory obligations relating to the distribution of opioids. Read More »

AMGEN INCC.: Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant

Amgen (NASDAQ:AMGN) today announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States (U.S.), will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets. Read More »

ABBVIE: AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. Read More »

ABBVIE: Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). Read More »