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Chronological Index of : Company News

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  • COMPANY NEWS: Hyperion to acquire Clal's diabetes unit

    Hyperion Therapeutics Inc. (NASDAQ:HPTX) will acquire the Andromeda Biotech Ltd. diabetes subsidiary of Clal Biotechnology Industries Ltd. (Tel Aviv:CBI) in a cash and stock deal. Clal will receive an upfront payment of…

    Published on 4/24/2014
  • COMPANY NEWS: Medivation, OncoFusion in bromodomain deal

    OncoFusion Therapeutics Inc. (Ann Arbor, Mich.) granted Medivation Inc. (NASDAQ:MDVN) access to OncoFusion's preclinical library of small molecule inhibitors of the BET bromodomain family. Medivation will have exclusive…

    Published on 4/24/2014
  • COMPANY NEWS: TB Alliance grants Fosun Chinese rights to TB regimen

    The not-for-profit Global Alliance for TB Drug Development granted Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) exclusive rights to develop and commercialize the alliance's PaMZ tuberculosis…

    Published on 4/24/2014
  • COMPANY NEWS: FDA approves J&J's siltuximab

    FDA approved a BLA for Sylvant siltuximab from Johnson & Johnson (NYSE:JNJ) to treat multicentric Castleman's disease in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. The chimeric mAb against …

    Published on 4/23/2014
  • COMPANY NEWS: Mitsubishi Tanabe names new CEO

    Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) proposed a number of changes to its executive management and board, including naming Masayuki Mitsuka president, CEO and a director. He would replace Michihiro Tsuchiya, who …

    Published on 4/23/2014
  • COMPANY NEWS: AbbVie submits NDA for all-oral HCV regimen

    AbbVie Inc. (NYSE:ABBV) submitted an NDA to FDA for its all-oral regimen comprising ABT-450 plus the company's Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. The …

    Published on 4/22/2014
  • COMPANY NEWS: Advisory committee rebuffs MoxDuo IR

    FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approval of MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) to treat moderate to severe acute pain. The panel …

    Published on 4/22/2014
  • COMPANY NEWS: Biocad's rituximab biosimilar approved in Russia

    Biocad (St. Petersburg, Russia) said the Russian Ministry of Health approved the company's AcellBia (BCD-20), a biosimilar of autoimmune and cancer drug rituximab. Biocad said AcellBia is the first mAb biosimilar to be …

    Published on 4/22/2014
  • COMPANY NEWS: NICE rebuffs Kadcyla

    The U.K.'s NICE issued draft guidance recommending against the use of Kadcyla trastuzumab emtansine from Roche (SIX:ROG; OTCQX:RHHBY) to treat HER2-positive, unresectable, locally advanced or metastatic breast cancer in…

    Published on 4/22/2014
  • COMPANY NEWS: Valeant makes bid to merge with Allergan

    Allergan Inc. (NYSE:AGN) gained $21.65 (15%) to $163.65 on Tuesday after Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) made public an unsolicited offer to merge with Allergan in a cash and stock deal …

    Published on 4/22/2014
  • COMPANY NEWS: AZ gains on rumored talks with Pfizer

    AstraZeneca plc (LSE:AZN; NYSE:AZN) gained $5.61 to $69.10 in New York on Monday on media reports that the pharma was in "informal, now-discontinued talks" with Pfizer Inc. (NYSE:PFE) for the pharma to acquire AZ for …

    Published on 4/21/2014
  • COMPANY NEWS: Cubist submits NDA for ceftolozane/tazobactam

    Cubist Pharmaceuticals Inc. (NASDAQ:CBST) submitted an NDA to FDA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The company plans to …

    Published on 4/21/2014
  • COMPANY NEWS: FDA approves Lilly's ramucirumab

    FDA approved Cyramza ramucirumab from Eli Lilly and Co. (NYSE:LLY) as monotherapy for advanced stomach cancer or gastroesophageal junction adenocarcinoma after prior fluoropyrimidine- or platinum-containing chemotherapy…

    Published on 4/21/2014
  • COMPANY NEWS: FDA to again review Gilead's cobicistat, elvitegravir

    FDA accepted for review two resubmitted NDAs from Gilead Sciences Inc. (NASDAQ:GILD) for cobicistat and elvitegravir. Cobicistat is under review as a boosting agent for HIV treatment with protease inhibitors, with an …

    Published on 4/21/2014
  • COMPANY NEWS: Sarepta jumps on eteplirsen update

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) jumped $9.58 (39%) to $33.98 on Monday after the company said it plans to submit an NDA to FDA for eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) by year end. …

    Published on 4/21/2014
  • COMPANY NEWS: Supreme Court denies stay on Copaxone ruling

    The U.S. Supreme Court denied a motion from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to stay an appeals court ruling that will end exclusivity for the biotech's multiple sclerosis (MS) drug Copaxone glatiramer …

    Published on 4/21/2014
  • COMPANY NEWS: FDA briefing docs rebuff MoxDuo IR

    FDA's Bob Rappaport said the agency's review team has been "unable to conclude that there is a safety benefit" for MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY), which is under review to treat …

    Published on 4/18/2014
  • COMPANY NEWS: FDA committee to discuss olaparib

    FDA's Oncologic Drugs Advisory Committee will meet on June 25 to discuss an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for olaparib as maintenance treatment of platinum-sensitive relapsed ovarian cancer. The pharma …

    Published on 4/18/2014
  • COMPANY NEWS: FDA approves Arzerra for first-line CLL

    FDA approved an sBLA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanding the label for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The new indication covers the use of …

    Published on 4/17/2014
  • COMPANY NEWS: 23andMe hires Hagenkord as CMO

    Personal genomics company 23andMe Inc. (Mountain View, Calif.) hired Jill Hagenkord as CMO, a newly created position. She was SVP of medical strategy at genetic diagnostics company Invitae Corp. (San Francisco, Calif.).…

    Published on 4/16/2014
  • COMPANY NEWS: BioAlliance to merge with Topotarget

    Cancer companies BioAlliance Pharma S.A. (Euronext:BIO) and Topotarget A/S (CSE:TOPO) will merge in a stock deal to create a company focused on Orphan cancers. Topotarget shareholders will own about a third of the …

    Published on 4/16/2014
  • COMPANY NEWS: Court temporarily halts Massachusetts Zohydro ban

    A judge in the U.S. District Court for the District of Massachusetts granted a preliminary injunction stopping Massachusetts' statewide ban on pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX).…

    Published on 4/15/2014
  • COMPANY NEWS: FDA approves GSK's albiglutide

    FDA approved Tanzeum albiglutide from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat Type II diabetes as monotherapy or as add-on therapy. GSK plans to launch Tanzeum in the U.S. next quarter, but declined to comment …

    Published on 4/15/2014
  • COMPANY NEWS: Germany again rebuffs Trobalt

    Germany's Federal Joint Committee (G-BA) again concluded that epilepsy drug Trobalt retigabine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has "no additional benefit" vs. individualized antiepileptic therapy. According…

    Published on 4/15/2014
  • COMPANY NEWS: IQWiG rebuffs Novo's NovoEight

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that NovoEight turoctocog alfa from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) has "no additional benefit" vs. …

    Published on 4/15/2014

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