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    The U.K.'s NICE issued draft guidance concerning the cost effectiveness of Type II diabetes drug Jardiance empagliflozin (BI-10773) from partners Boehringer Ingelheim GmbH (Ingelheim, Germany) and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

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