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Chronological Index of : Company News

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  • COMPANY NEWS: Amicus speeds Amigal submission timeline

    Amicus Therapeutics Inc. (NASDAQ:FOLD) rose $3.11 (33%) to $12.46 on Thursday after the company said it will submit regulatory applications in the U.S. and Europe this year for Amigal migalastat to treat Fabry's disease…

    Published on 3/19/2015
  • COMPANY NEWS: Court sides with Sandoz in Amgen biosimilar case

    The U.S. District Court for the Northern District of California denied motions made by Amgen Inc. (NASDAQ:AMGN) against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) that would have delayed sales of Zarxio …

    Published on 3/19/2015
  • COMPANY NEWS: FDA panel backs Breo Ellipta for adults, not children

    FDA's Pulmonary-Allergy Drugs Advisory and Drug Safety and Risk Management Advisory committees voted 16-4 to recommend approval of Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)…

    Published on 3/19/2015
  • COMPANY NEWS: J&J buys single-asset anticoagulant company XO1

    The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) acquired XO1 Ltd. (Cambridge, U.K.), a single-asset cardiovascular company developing preclinical anticoagulant ichorcumab. J&J spokesperson Ellen …

    Published on 3/19/2015
  • COMPANY NEWS: Lilly licenses Hanmi's Btk inhibitor

    Eli Lilly and Co. (NYSE:LLY) obtained exclusive, worldwide rights outside of certain Asian territories to HM71224, an oral Bruton's tyrosine kinase (Btk) inhibitor from Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940). The…

    Published on 3/19/2015
  • COMPANY NEWS: Management tracks

    Cell therapy company Fibrocell Science Inc. (NASDAQ:FCSC) hired Keith Goldan as SVP and CFO. Goldan was SVP and CFO of NuPathe Inc., which was acquired by Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).Ophthalmic play …

    Published on 3/19/2015
  • COMPANY NEWS: Management tracks

    Agilent Technologies Inc. (NYSE:A) promoted Mike McMullen from COO to CEO; he will retain his role as president. He succeeds William Sullivan, who will be a company advisor until his retirement on Oct. 31. Trovagene Inc…

    Published on 3/18/2015
  • COMPANY NEWS: FDA reviewers focus on safety of Breo Ellipta

    FDA will ask its Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees to vote on whether to recommend a large pre- or post-approval safety trial to evaluate serious asthma outcomes for Breo …

    Published on 3/17/2015
  • COMPANY NEWS: Galapagos, J&J terminate inflammation deal

    Galapagos N.V. (Euronext:GLPG; Pink:GLPYY) and the Janssen Pharmaceutica NV unit of Johnson & Johnson (NYSE:JNJ) terminated a 2007 deal to develop small molecules for inflammation. Galapagos will regain all rights to …

    Published on 3/17/2015
  • COMPANY NEWS: Management tracks

    Molecular Partners AG (SIX:MOLN) named Andreas Harstrick CMO, effective May 1. Harstrick was SVP of medical science at the ImClone Systems Inc. subsidiary of Eli Lilly and Co. (NYSE:LLY); he served on Lilly's oncology …

    Published on 3/17/2015
  • COMPANY NEWS: Management tracks

    Oral therapies developer Chiasma Inc. (Jerusalem, Israel) named Mark Leuchtenberger president and CEO. Leuchtenberger was president and CEO of Acusphere Inc. (Pink:ACUS). Leuchtenberger succeeds Roni Mamluk, whom …

    Published on 3/16/2015
  • COMPANY NEWS: Merck expects third FDA rejection for sugammadex

    FDA canceled Wednesday's meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss sugammadex (MK-8616) from Merck & Co. Inc. (NYSE:MRK). The company said it expects to receive a complete …

    Published on 3/16/2015
  • COMPANY NEWS: Valeant raises Salix bid, Endo retreats

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) raised its bid to acquire Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) to $173 per share, or $11.4 billion in cash, while competing bidder Endo International …

    Published on 3/16/2015
  • COMPANY NEWS: Boehringer eyeing NASH space with Pharmaxis option

    Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) granted Boehringer Ingelheim GmbH (Ingelheim, Germany) an exclusive option to acquire worldwide rights to PXS4728A. According to Pharmaxis, Boehringer is interested in developing the…

    Published on 3/13/2015
  • COMPANY NEWS: District court hears Amgen, Sandoz biosimilars case

    The U.S. District Court for the Northern District of California on Friday accepted motions in the biosimilars dispute between Amgen Inc. (NASDAQ:AMGN) and the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) that could …

    Published on 3/13/2015
  • COMPANY NEWS: Samsung Bioepis submits MAA for Remicade biosimilar

    Samsung Bioepis Co. Ltd., a JV between Samsung Group (Seoul, South Korea) and Biogen Idec Inc. (NASDAQ:BIIB), submitted an MAA to EMA for SB2, a biosimilar of autoimmune drug Remicade infliximab from Merck & Co. Inc. (…

    Published on 3/13/2015
  • COMPANY NEWS: SEC: Gilead, Vertex can't block shareholder vote on pricing risk

    Gilead Sciences Inc. (NASDAQ:GILD) and Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) have been told they must allow shareholders to vote on proposals by the UAW Retiree Medical Benefits Trust asking the companies to …

    Published on 3/13/2015
  • COMPANY NEWS: WuXi expanding to manufacture CAR T immunotherapies

    WuXi PharmaTech Inc. (NYSE:WX) disclosed the cell therapy manufacturing facility it will build in the U.S. will provide clinical- and commercial-scale production of chimeric antigen receptor T (CAR T) cells as well as …

    Published on 3/13/2015
  • COMPANY NEWS: 23andMe to build target discovery group around Scheller

    23andMe Inc. (Mountain View, Calif.) announced it will launch a therapeutics group led by newly appointed CSO Richard Scheller, the former EVP of research and early development at the Genentech Inc. unit of Roche (SIX:…

    Published on 3/12/2015
  • COMPANY NEWS: Kura licenses J&J's tipifarnib, raises $60M

    Kura Oncology Inc. (La Jolla, Calif.) licensed a cancer compound from the Janssen Pharmaceutica NV unit of Johnson & Johnson (NYSE:JNJ), reverse-merged with shell company Zeta Acquisition Corp. III and raised $60 …

    Published on 3/12/2015
  • COMPANY NEWS: Management tracks

    Huya Bioscience International LLC (San Diego, Calif.), which is developing oncology and cardiovascular candidates sourced in China, appointed Alain Rolland EVP and CSO. Rolland was most recently EVP of product …

    Published on 3/12/2015
  • COMPANY NEWS: Newco Annias debuts with glioblastoma vaccine

    Immuno-oncology newco Annias Immunotherapeutics Inc. (Chapel Hill, N.C.) debuted with IP licensed from Duke University to a clinical-stage vaccine that targets solid tumors and a method to boost the vaccine's activity.…

    Published on 3/12/2015
  • COMPANY NEWS: Acadia falls as NDA timeline slows, CEO retires

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) shed $13.26 (30%) to $31.50 in after-hours trading after it said it would delay to 2H15 its NDA submission for Nuplazid pimavanserin to treat Parkinson's disease psychosis (PDP…

    Published on 3/11/2015
  • COMPANY NEWS: Astellas denies disbanding U.S. business development team

    Astellas Pharma Inc. (Tokyo:4503) denied rumors that it has disbanded its U.S. business development team in the wake of its announcement last month that it is centralizing its global corporate and business development …

    Published on 3/11/2015
  • COMPANY NEWS: Management tracks

    Neovacs S.A. (Euronext:ALNEV) hired Therese Croughs as CMO, effective immediately, and promoted Geraldine Grouard-Vogel to CSO from head of research and preclinical development. Croughs, who succeeds Pierre …

    Published on 3/11/2015

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