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Chronological Index of : Company News

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  • COMPANY NEWS: Alimera gains on Iluvien approval

    Alimera Sciences Inc. (NASDAQ:ALIM) added $0.41 to $5.33 on Monday after FDA approved Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema in patients who have been previously treated with…

    Published on 9/29/2014
  • COMPANY NEWS: AMAG gains on M&A deal to add Makena

    AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) jumped $6.54 (28%) to $29.72 Monday on news it agreed to acquire the maternal health business of Lumara Health Inc. (Chesterfield, Mo.) -- once known as KV Pharmaceutical Co. -- …

    Published on 9/29/2014
  • COMPANY NEWS: EMA validates Opdivo MAA

    Bristol-Myers Squibb Co. (NYSE:BMY) said EMA validated an MAA for Opdivo nivolumab to treat non-small cell lung cancer (NSCLC). The pharma said the application is the "first completed regulatory submission" for a PD-1 …

    Published on 9/29/2014
  • COMPANY NEWS: Agios jumps on prospect of Phase I data

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO) was up $10.31 (19%) to $63.76 on Friday on news that Phase I data for AG-120 will be announced at a late-breaking oral presentation at the EORTC-NCI-AACR Symposium on Molecular …

    Published on 9/26/2014
  • COMPANY NEWS: BMS's Opdivo gets Priority Review

    Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted for filing and granted Priority Review to a BLA for Opdivo nivolumab to treat previously treated advanced melanoma. The PDUFA date is March 30, 2015. The pharma said…

    Published on 9/26/2014
  • COMPANY NEWS: CHMP backs Cyramza, Trulicity and Moventig

    EMA's CHMP recommended approval of three compounds already approved in the U.S.: Cyramza ramucirumab and Trulicity dulaglutide from Eli Lilly and Co. (NYSE:LLY), and Moventig naloxegol from AstraZeneca plc (LSE:AZN; …

    Published on 9/26/2014
  • COMPANY NEWS: CHMP backs Teva's Egranli for neutropenia

    EMA's CHMP recommended marketing authorization of Egranli balugrastim from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to prevent chemotherapy-induced neutropenia. Approval will include a pharmacovigilance plan. …

    Published on 9/26/2014
  • COMPANY NEWS: CHMP recommends Boehringer's nintedanib for NSCLC

    EMA's CHMP recommended approval of Vargatef nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany) plus docetaxel to treat locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) …

    Published on 9/26/2014
  • COMPANY NEWS: FDA approves Iluvien for DME

    FDA approved an NDA from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) for Iluvien fluocinolone acetonide (FA) intravitreal implant to treat diabetic macular edema in patients who have …

    Published on 9/26/2014
  • COMPANY NEWS: GlycoMimetics down on Phase III delay

    GlycoMimetics Inc. (NASDAQ:GLYC) fell $1.04 (13%) to $7.19 on Friday after it said Phase III testing of rivipansel (GMI-1070) for sickle cell disease will be "substantially delayed" due to manufacturing issues.Partner …

    Published on 9/26/2014
  • COMPANY NEWS: Japan approves pegfilgrastim for neutropenia

    Japan's Ministry of Health, Labor and Welfare (MHLW) approved G-Lasta pegfilgrastim (KRN125) from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat chemotherapy-induced febrile neutropenia. Kyowa has Japanese rights to …

    Published on 9/26/2014
  • COMPANY NEWS: Biogen Idec hires gene therapy SVP

    Biogen Idec Inc. (NASDAQ:BIIB) moved a step further into the gene editing space by hiring Olivier Danos as SVP of gene therapy, a newly created position. The company said it is "exploring" gene editing technologies and …

    Published on 9/25/2014
  • COMPANY NEWS: CHMP backs Almirall's Duaklir for COPD

    EMA's CHMP recommended marketing authorization of Duaklir Genuair aclidinium bromide/formoterol fumarate (LAS40464) from Almirall S.A. (Madrid:ALM) as a maintenance bronchodilator to treat symptoms of chronic …

    Published on 9/25/2014
  • COMPANY NEWS: CRUK, MedImmune ally on cancer biologics

    Cancer Research UK and the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) said they will establish the joint CRUK-MEDI Alliance Laboratory in Cambridge, U.K. The five-year public-private partnership will seek…

    Published on 9/25/2014
  • COMPANY NEWS: Epirus, Livzon in Asian biosimilar deal

    Epirus Biopharmaceuticals Inc. (NASDAQ:EPRS) partnered with Livzon Mabpharm Inc. (Zhuhai City, China) to develop, manufacture and commercialize up to five biosimilar antibodies in Asia. The deal includes Infimab …

    Published on 9/25/2014
  • COMPANY NEWS: GSK taps Hampton as next chairman

    GlaxoSmithKline plc (LSE:GSK, NYSE:GSK) named Philip Hampton to its board of directors and said he will become its new non-executive chairman no later than Sept. 1, 2015.Hampton is chairman of the Royal Bank of Scotland…

    Published on 9/25/2014
  • COMPANY NEWS: BioMarin preparing for generic Kuvan suit

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said an undisclosed company submitted an ANDA to FDA for a generic version of BioMarin's Kuvan sapropterin dihydrochloride to treat phenylketonuria.BioMarin said it has eight …

    Published on 9/24/2014
  • COMPANY NEWS: FDA accepts brexpiprazole NDA

    Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and H. Lundbeck A/S (CSE:LUN) said FDA accepted for review an NDA for brexpiprazole to treat schizophrenia and as an adjunct treatment for major depressive disorder (MDD). …

    Published on 9/24/2014
  • COMPANY NEWS: Kadmon names Harlan Waksal president, CEO

    In a move that could signal Kadmon Corp. LLC (New York, N.Y.) is preparing for an IPO, the company named Harlan Waksal as president and CEO. He replaces his brother, Samuel Waksal, as CEO. Samuel Waksal will remain …

    Published on 9/24/2014
  • COMPANY NEWS: Merrimack grants Baxter rights to MM-398

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) granted Baxter International Inc. (NYSE:BAX) exclusive rights outside of the U.S. and Taiwan to develop and commercialize MM-398. The nanoparticle liposome formulation of …

    Published on 9/24/2014
  • COMPANY NEWS: FDA approves Celgene's Otezla for psoriasis

    FDA approved an sNDA from Celgene Corp. (NASDAQ:CELG) for Otezla apremilast to treat moderate to severe plaque psoriasis. Celgene said the oral drug is the only approved phosphodiesterase-4 (PDE-4) inhibitor for the …

    Published on 9/23/2014
  • COMPANY NEWS: Galmed surges on NASH news

    Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) jumped $2.45 (38%) to $8.93 on Tuesday after FDA granted Fast Track designation to Aramchol arachidyl amino cholanoic acid to treat non-alcoholic steatohepatitis (NASH).Galmed …

    Published on 9/23/2014
  • COMPANY NEWS: T2 gains on approval of fungal tests

    T2 Biosystems Inc. (NASDAQ:TTOO) jumped $1.62 (10%) to $18.55 on Tuesday after FDA approved the company's T2Candida Panel and T2Dx instrument to detect Candida pathogens that lead to sepsis. The two products use …

    Published on 9/23/2014
  • COMPANY NEWS: Auxilium board affirms QLT deal

    The board of Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) unanimously reaffirmed its proposed merger agreement with ophthalmic play QLT Inc. (NASDAQ:QLTI; TSX:QLT) after reviewing an unsolicited bid from Endo …

    Published on 9/22/2014
  • COMPANY NEWS: Avalon, GSK launch two newcos

    Avalon Ventures and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) launched Silarus Therapeutics Inc. (San Diego, Calif.) and Thyritope Biosciences Inc. (San Diego, Calif.). Each may receive up to $10 million in series A …

    Published on 9/22/2014

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