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Chronological Index of : Company News

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  • COMPANY NEWS: Alder falls after BMS returns clazakizumab rights

    Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) fell $2.24 (13%) to $14.80 on Tuesday after Bristol-Myers Squibb Co. (NYSE:BMY) discontinued development of clazakizumab (BMS-945429) and returned worldwide rights to Alder. …

    Published on 9/2/2014
  • COMPANY NEWS: Amgen submits evolocumab MAA

    Amgen Inc. (NASDAQ:AMGN) submitted an MAA to EMA for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the EU for…

    Published on 9/2/2014
  • COMPANY NEWS: Amgen submits talimogene MAA

    Amgen Inc. (NASDAQ:AMGN) submitted an MAA to EMA for talimogene laherparepvec to treat regionally and distantly metastatic melanoma. In July, Amgen disclosed that it submitted a BLA to FDA for the modified herpes …

    Published on 9/2/2014
  • COMPANY NEWS: Epizyme's Rhodes resigns as president, CFO

    Cancer epigenetics company Epizyme Inc. (NASDAQ:EPZM) said Jason Rhodes resigned as president and CFO, effective Sept. 30. The company said Rhodes is joining an undisclosed VC fund. Prior to joining Epizyme in 2010, …

    Published on 9/2/2014
  • COMPANY NEWS: HHS awards $24.9M to Mapp

    HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded Mapp Biopharmaceutical Inc. (San Diego, Calif.) a $24.9 million, 18-month contract for development and manufacturing of the company's …

    Published on 9/2/2014
  • COMPANY NEWS: Novo Nordisk discontinues inflammation R&D

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) is discontinuing all inflammatory disease R&D. Novo ended development of its lead compound in the space, NN8226, which is a recombinant human mAb neutralizing IL-20 in Phase II …

    Published on 9/2/2014
  • COMPANY NEWS: Priority Review for Actavis' eluxadoline

    FDA accepted and granted Priority Review to an NDA from Actavis plc (NYSE:ACT) for eluxadoline (JNJ-270189066) to treat diarrhea and abdominal pain in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).…

    Published on 9/2/2014
  • COMPANY NEWS: Roche had multiple competitors in InterMune acquisition

    InterMune Inc. (NASDAQ:ITMN) revealed in an SEC filing that multiple other companies expressed interest in a deal before Roche (SIX:ROG; OTCQX:RHHBY) agreed to acquire InterMune for $74 per share, or $8.3 billion in …

    Published on 9/2/2014
  • COMPANY NEWS: UTHR soars on patent win

    United Therapeutics Corp. (NASDAQ:UTHR) gained $26.14 (29%) to $117.83 on Friday after the U.S. District Court for the District of New Jersey ruled that Sandoz's ANDA for generic intravenous treprostinil will infringe …

    Published on 8/29/2014
  • COMPANY NEWS: China approves BTG's DC Bead

    BTG plc (LSE:BTG) and SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) said the China Food and Drug Administration (CFDA) approved BTG's DC Bead to treat patients with malignant hypervascularized tumors like hepatocellular …

    Published on 8/28/2014
  • COMPANY NEWS: Luye buys majority stake in Beijing Jialin

    Luye Pharma Group Ltd. (HKSE:2186) will acquire a 58% stake in Beijing Jialin Pharmaceutical Co. Ltd. from Beijing Jialin shareholders Mylin Holding Group Co. Ltd. (Beijing, China) and Beijing CITIC in a tranched RMB3.7…

    Published on 8/28/2014
  • COMPANY NEWS: NICE requests Jardiance cost effectiveness data

    The U.K.'s NICE issued draft guidance concerning the cost effectiveness of Type II diabetes drug Jardiance empagliflozin (BI-10773) from partners Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (…

    Published on 8/28/2014
  • COMPANY NEWS: Roche, Chugai amend licensing deal

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said it and majority owner Roche (SIX:ROG; OTCQX:RHHBY) amended an agreement covering the geographic regions and timing of Roche's first refusal rights to Chugai compounds. …

    Published on 8/28/2014
  • COMPANY NEWS: Allergan sets special meeting date

    Allergan Inc. (NYSE:AGN) set a Dec. 18 date for a special shareholder meeting at which Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX) and hedge fund Pershing Square Capital hope to install board members …

    Published on 8/27/2014
  • COMPANY NEWS: Amgen gets Priority Review for ivabradine

    FDA accepted and granted Priority Review to an NDA from Amgen Inc. (NASDAQ:AMGN) for ivabradine to treat chronic heart failure (CHF). The selective If channel inhibitor is already marketed as Procoralan in about 100 …

    Published on 8/27/2014
  • COMPANY NEWS: EC approves BMS's daclatasvir for HCV

    The European Commission approved Daklinza daclatasvir (BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY) in combination with other therapies to treat HCV genotypes 1, 2, 3 and 4.BMS said the selective HCV NS5A …

    Published on 8/27/2014
  • COMPANY NEWS: European approval for Velphoro

    The European Commission approved Velphoro sucroferric oxyhydroxide from Vifor-Fresenius Medical Care Renal Pharma Ltd. to control serum phosphorus levels in adults with chronic kidney disease (CKD) on hemodialysis or …

    Published on 8/27/2014
  • COMPANY NEWS: Sanofi's Moulding to become North America president

    Sanofi (Euronext:SAN; NYSE:SNY) said Jez Moulding will transition to president of North America pharmaceuticals, effective Oct. 1. He will replace Anne Whitaker, who is joining Synta Pharmaceuticals Corp. (NASDAQ:SNTA) …

    Published on 8/27/2014
  • COMPANY NEWS: Biogen Idec hires Johns as VP of new ALS unit

    Biogen Idec Inc. (NASDAQ:BIIB) hired Donald Johns as VP of the company's new innovation hub focused on amyotrophic lateral sclerosis. Johns was VP and global head of neuroscience translational medicine at Novartis …

    Published on 8/26/2014
  • COMPANY NEWS: FDA approves Promacta sNDA

    FDA approved an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for once-daily use of Promacta eltrombopag in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive …

    Published on 8/26/2014
  • COMPANY NEWS: Luye gains Chinese rights to Hanmi's poziotinib

    Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) granted Luye Pharma Group Ltd. (HKSE:2186) exclusive rights to develop and commercialize poziotinib (HM781-36B) in China. The oral pan-HER inhibitor is in Phase II trials to…

    Published on 8/26/2014
  • COMPANY NEWS: Medtronic acquires Sapiens

    Medtronic Inc. (NYSE:MDT) acquired medical device company Sapiens Steering Brain Stimulation B.V. (Eindhoven, the Netherlands) for EUR 150 million ($200.8 million) in cash. Sapiens, which is developing deep brain …

    Published on 8/26/2014
  • COMPANY NEWS: Alkermes submits NDA for aripiprazole

    Alkermes plc (NASDAQ:ALKS) submitted an NDA to FDA for aripiprazole lauroxil (ALKS 9070, ALKS 9072) to treat schizophrenia. The product is a once-monthly, injectable formulation of aripiprazole, an atypical …

    Published on 8/25/2014
  • COMPANY NEWS: J&J acquires antibody play Covagen

    The Cilag GmbH International subsidiary of Johnson & Johnson (NYSE:JNJ) acquired mAb platform company Covagen AG (Zurich, Switzerland) for an undisclosed amount. Covagen is developing a pipeline of products using its …

    Published on 8/25/2014
  • COMPANY NEWS: EMA to review Basilea's isavuconazole

    EMA accepted for review an MAA from Basilea Pharmaceutica AG (SIX:BSLN) for isavuconazole (BAL8557) to treat invasive aspergillosis and mucormycosis (zygomycosis). Last month, partner Astellas Pharma Inc. (Tokyo:4503) …

    Published on 8/21/2014

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