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  • COMPANY NEWS: FDA approves Eliquis for DVT, pulmonary embolism

    FDA approved an sNDA for Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) to treat and to reduce the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE). The …

    Published on 8/21/2014
  • COMPANY NEWS: J&J gains option to ViaCyte's VC-01

    ViaCyte Inc. (San Diego, Calif.) granted the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) an option to license rights to VC-01, which is in development for Type I diabetes. J&J's Johnson & …

    Published on 8/21/2014
  • COMPANY NEWS: AZ, Mitsubishi Tanabe in diabetic nephropathy deal

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) partnered to validate and progress novel targets and small molecules for diabetic nephropathy into the clinic under a three-year …

    Published on 8/20/2014
  • COMPANY NEWS: BMS, Celgene partner on Phase I trial for Abraxane/Opdivo

    Bristol-Myers Squibb Co. (NYSE:BMY) and Celgene Corp. (NASDAQ:CELG) partnered to conduct a Phase I trial to evaluate Celgene's Abraxane nab-paclitaxel in combination with BMS's cancer immunotherapy Opdivo nivolumab. …

    Published on 8/20/2014
  • COMPANY NEWS: FDA approves Kronus' Type I diabetes test

    FDA will allow Kronus Market Development Inc. (Star, Idaho) to market Kronus' ZnT8Ab ELISA diagnostic, which differentiates Type I diabetes from Type II or gestational diabetes. The blood-based assay detects the …

    Published on 8/20/2014
  • COMPANY NEWS: Hospira suing FDA over Precedex generic approval

    Hospira Inc. (NYSE:HSP) filed suit against FDA in the U.S. District Court for the District of Maryland alleging FDA's decision to approve generic versions of Hospira's Precedex dexmedetomidine so long as the labels for …

    Published on 8/20/2014
  • COMPANY NEWS: NICE now backs Revlimid for MDS

    The U.K.'s NICE issued a final appraisal determination (FAD) recommending Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) to treat patients with transfusion-dependent anemia with low- or intermediate-1-risk …

    Published on 8/20/2014
  • COMPANY NEWS: Pfizer, CCFA partner to fund IBD research

    Pfizer Inc. (NYSE:PFE) and the Crohn's & Colitis Foundation of America will fund up to four academic projects focused on developing small molecules to treat Crohn's disease and ulcerative colitis. A committee comprising…

    Published on 8/20/2014
  • COMPANY NEWS: TB Alliance gains Novartis tuberculosis portfolio

    Novartis AG (NYSE:NVS; SIX:NOVN) granted the Global Alliance for TB Drug Development (TB Alliance) exclusive, worldwide rights to the entire portfolio of preclinical tuberculosis (TB) compounds discovered at the …

    Published on 8/20/2014
  • COMPANY NEWS: Emergent, MorphoSys to co-develop MOR209/ES414

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) partnered with Emergent BioSolutions Inc. (NYSE:EBS) to develop and commercialize ES414, a bispecific ADAPTIR antibody targeting prostate-specific membrane antigen (PSMA; FOLH1; …

    Published on 8/19/2014
  • COMPANY NEWS: Evotec, MMV providing researchers compounds free of charge

    Evotec AG (Xetra:EVT) will use its compound management services to support the Malaria and Pathogen Box initiatives from Medicines for Malaria Venture, through which the not-for-profit provides researchers molecules to …

    Published on 8/19/2014
  • COMPANY NEWS: FDA accepts Boehringer tiotropium/olodaterol NDA

    Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA accepted for review an NDA for a once-daily, fixed-dose combination of tiotropium/olodaterol delivered via the company's Respimat soft mist inhaler to treat …

    Published on 8/19/2014
  • COMPANY NEWS: FDA approves Genzyme's Cerdelga

    FDA approved Cerdelga eliglustat from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat Type I Gaucher's disease. The product is also under review in Europe for the indication. Genzyme said it plans to …

    Published on 8/19/2014
  • COMPANY NEWS: Novartis buying Gamida stake, gains option to acquire

    Novartis AG (NYSE:NVS; SIX:NOVN) will pay $35 million to acquire a 15% equity stake in Gamida Cell Ltd. (Jerusalem, Israel) and an option to acquire the Israeli biotech for $165 million in cash and up to $435 million in…

    Published on 8/19/2014
  • COMPANY NEWS: Salix jumps on rumored Allergan bid

    Gastrointestinal company Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) jumped $21.63 (16%) to $160.80 on Tuesday on media reports that Allergan Inc. (NYSE:AGN) approached Salix regarding an acquisition offer. According to …

    Published on 8/19/2014
  • COMPANY NEWS: Tentative FDA approval for Lilly, Boehringer insulin glargine

    FDA granted tentative approval to Basaglar insulin glargine (LY2963016) from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and Type II diabetes. The tentative approval …

    Published on 8/19/2014
  • COMPANY NEWS: Eisai submits lenvatinib NDA, MAA

    Eisai Co. Ltd. (Tokyo:4523) submitted an NDA to FDA and an MAA to EMA seeking approval of lenvatinib (E7080) to treat progressive, radioiodine-refractory differentiated thyroid cancer. Late last month, the pharma said …

    Published on 8/18/2014
  • COMPANY NEWS: Huya partners with Changzhou center

    Huya Bioscience International LLC (San Diego, Calif.) partnered with the Changzhou Center for Biotech Development to help globally commercialize compounds developed by pharma and biotech companies located in Changzhou, …

    Published on 8/18/2014
  • COMPANY NEWS: Pfizer completes palbociclib NDA submission

    Pfizer Inc. (NYSE:PFE) completed submission of a rolling NDA to FDA for palbociclib (PD-0332991) in combination with Femara letrozole as first-line treatment of estrogen receptor-positive, HER2-negative advanced breast …

    Published on 8/18/2014
  • COMPANY NEWS: FDA approves Biogen Idec's Plegridy

    FDA approved Plegridy peginterferon beta-1a from Biogen Idec Inc. (NASDAQ:BIIB) to treat relapsing forms of multiple sclerosis (RRMS). The pegylated interferon (IFN) beta-1a is administered subcutaneously every two …

    Published on 8/15/2014
  • COMPANY NEWS: Gilead claims victory in Sovaldi arbitration

    Gilead Sciences Inc. (NASDAQ:GILD) disclosed in an SEC filing that an arbitration panel ruled Roche (SIX:ROG; OTCQX:RHHBY) failed to establish its claims to Gilead's HCV drug Sovaldi sofosbuvir. Roche initiated …

    Published on 8/15/2014
  • COMPANY NEWS: IQWiG again rebuffs Eisai's Fycompa

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said epilepsy drug Fycompa perampanel from Eisai Co. Ltd. (Tokyo:4523) provides "no additional benefit" over appropriate comparators to treat partial …

    Published on 8/15/2014
  • COMPANY NEWS: IQWiG backs Novartis' Jakavi for MF

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Orphan drug Jakavi ruxolitinib from Novartis AG (NYSE:NVS; SIX:NOVN) has "significant" additional benefit over best supportive care (BSC) to …

    Published on 8/15/2014
  • COMPANY NEWS: Allergan acquires Taris' LiRIS lidocaine system

    Allergan Inc. (NYSE:AGN) acquired LiRIS from Taris Biomedical Inc. (Lexington, Mass.) for $67.5 million in cash up front and up to $520 million in milestones. LiRIS, a lidocaine-releasing intravesical system, is in …

    Published on 8/14/2014
  • COMPANY NEWS: Celltrion grants Remsima marketing rights to Mundipharma

    Celltrion Inc. (KOSDAQ:068270) subsidiary Celltrion Healthcare Hungary Kft granted Mundipharma International Ltd. (Cambridge, U.K.) exclusive distribution rights to market Remsima infliximab in the U.K., Germany, Italy,…

    Published on 8/14/2014

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