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Chronological Index of : Company News

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  • 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
  • COMPANY NEWS: Coherus reports PK data for Humira biosimilar

    Coherus BioSciences Inc. (Redwood City, Calif.) said CHS-1420, its biosimilar of Humira adalimumab, met the primary endpoint of pharmacokinetic similarity to Humira. PK endpoints measured maximum serum concentration, …

    Published on 8/14/2014
  • COMPANY NEWS: FDA committee backs Boehringer's Spiriva Respimat

    FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-3 that existing data support approval of Spiriva Respimat from Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat chronic obstructive pulmonary disease (…

    Published on 8/14/2014
  • COMPANY NEWS: Priority Review for Pfizer's meningitis B vaccine

    FDA accepted and granted Priority Review to a BLA from Pfizer Inc. (NYSE:PFE) for recombinant LP2086 (rLP2086) to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in people 10-25 years…

    Published on 8/14/2014
  • COMPANY NEWS: 23andMe, Pfizer to study IBD genetics

    23andMe Inc. (Mountain View, Calif.) partnered with Pfizer Inc. (NYSE:PFE) to explore the genetic factors associated with the onset, progression, severity and response to inflammatory bowel disease (IBD). Under the deal…

    Published on 8/13/2014
  • COMPANY NEWS: CDC backs routine use of Prevnar 13 in adults over 65

    The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended routine use of pneumococcal vaccine Prevnar/Prevenar 13 from Pfizer Inc. (NYSE:PFE) for adults 65 …

    Published on 8/13/2014
  • COMPANY NEWS: FDA reviewers highlight mixed safety for Spiriva Respimat

    An FDA reviewer said mortality data for Spiriva Respimat tiotropium from Boehringer Ingelheim GmbH (Ingelheim, Germany) are "not entirely consistent," between the Phase III TIOSPIR trial and a pooled analysis of placebo…

    Published on 8/13/2014
  • COMPANY NEWS: InterMune gains on rumored bids

    InterMune Inc. (NASDAQ:ITMN) rose $6.57 (14%) to $52.06 on Wednesday after media reports surfaced that at least four companies made bids to acquire the company and that InterMune has hired Goldman Sachs and Centerview …

    Published on 8/13/2014
  • COMPANY NEWS: Sanofi licenses preclinical compounds to China's Zai Lab

    Sanofi (Euronext:SAN; NYSE:SNY) granted newco Zai Laboratory Inc. (Shanghai, China) a worldwide license to develop, manufacture and commercialize two preclinical compounds to treat chronic respiratory diseases, …

    Published on 8/12/2014
  • COMPANY NEWS: Vertex discontinuing Incivek

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) will discontinue sales of HCV drug Incivek telaprevir in the U.S. by Oct. 16 in light of available alternative treatments and diminishing market demand, according to a letter …

    Published on 8/12/2014

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