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Chronological Index of : Company News

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  • COMPANY NEWS: Boehringer, WellPoint studying outcomes in AF

    Boehringer Ingelheim GmbH (Ingelheim, Germany) and the HealthCore Inc. unit of WellPoint Inc. (NYSE:WLP) have identified non-valvular atrial fibrillation (NVAF) as the first project under their July deal to collaborate …

    Published on 11/21/2014
  • COMPANY NEWS: CHMP backs psoriasis treatments from Novartis, Celgene

    EMA's CHMP recommended marketing authorization for Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) as a first-line treatment for adults with moderate to severe plaque psoriasis and Otezla apremilast from …

    Published on 11/21/2014
  • COMPANY NEWS: CHMP gives nod to AbbVie's HCV therapies

    EMA's CHMP recommended approval of Exviera dasabuvir and Viekirax, which is a two direct-acting-antiviral (2-DAA) combination of ombitasvir and paritaprevir (ABT-450) plus the booster Norvir ritonavir from AbbVie Inc. (…

    Published on 11/21/2014
  • COMPANY NEWS: CHMP supports Boehringer's nintedanib for IPF

    EMA's CHMP recommended marketing authorization of Ofev nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany) for the treatment of idiopathic pulmonary fibrosis (IPF). The compound is under accelerated …

    Published on 11/21/2014
  • COMPANY NEWS: G-BA: No additional benefit for Tecfidera in MS

    Germany's Federal Joint Committee (G-BA) has concurred with the Institute for Quality and Efficiency in Healthcare (IQWiG) that Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) offers no additional …

    Published on 11/21/2014
  • COMPANY NEWS: Genzyme's Cerdelga gets CHMP nod for Gaucher's

    EMA's CHMP recommended marketing authorization of Cerdelga eliglustat tartrate from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat Type I Gaucher's disease.Cerdelga is an oral ceramide analog that …

    Published on 11/21/2014
  • COMPANY NEWS: FDA approves Purdue's abuse-resistant hydrocodone

    FDA approved Hysingla ER hydrocodone bitartrate from Purdue Pharma L.P. (Stamford, Conn.) to treat chronic pain for which alternative treatment options are inadequate. Hysingla is a once-daily, abuse-deterrent extended-…

    Published on 11/20/2014
  • COMPANY NEWS: MM-398 put on Fast Track for pancreatic cancer

    PharmEngine Inc. (GreTai:4162) and partner Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) said FDA granted Fast Track designation to their MM-398 to treat metastatic pancreatic cancer in patients previously treated with …

    Published on 11/20/2014
  • COMPANY NEWS: Sanofi says new products will beat consensus by EUR 5B

    On its annual analyst call Thursday, Sanofi (Euronext:SAN; NYSE:SNY) said it plans to launch 18 new products by 2020 with cumulative sales of EUR 30 billion. Interim CEO and Chairman Serge Weinberg said the projection …

    Published on 11/20/2014
  • COMPANY NEWS: Knight vouches for Gilead

    Knight Therapeutics Inc. (TSX:GUD) sold a Priority Review voucher to Gilead Sciences Inc. (NASDAQ:GILD) for $125 million. Knight obtained the voucher under FDA's Tropical Disease Priority Review voucher program after …

    Published on 11/19/2014
  • COMPANY NEWS: Lee's gains China rights to Ikaria's INOmax

    Lee's Pharmaceutical Holdings Ltd. (HKSE:0950) received rights from Ikaria Inc. (Hampton, N.J.) to INOmax in China, Hong Kong, Macau and Taiwan. The inhaled nitric oxide to treat hypoxic respiratory failure associated …

    Published on 11/19/2014
  • COMPANY NEWS: Forward suing Biogen Idec in Germany

    Forward Pharma A/S (Copenhagen, Denmark) filed suit in a German court alleging that German sales of Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) infringe Forward's German utility model, which …

    Published on 11/18/2014
  • COMPANY NEWS: Gilead's Harvoni gains European approval

    The European Commission approved Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV genotype 1, 3 and 4 infection.Gilead said the Commission recommended Harvoni in courses of 12 …

    Published on 11/18/2014
  • COMPANY NEWS: Actavis to acquire Allergan for $66B

    Actavis plc (NYSE:ACT) will acquire Allergan Inc. (NYSE:AGN) for $66 billion, or $219 per share. The price represents a 10% premium to Allergan's closing price of $198.65 on Nov. 14 before the deal was announced. Both …

    Published on 11/17/2014
  • COMPANY NEWS: FDA approves Genzyme's Lemtrada

    FDA approved Lemtrada alemtuzumab from the Genzyme unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat adults with relapsing-remitting multiple sclerosis (RRMS) who have had an inadequate response to two or more prior …

    Published on 11/17/2014
  • COMPANY NEWS: Pfizer bets big on immuno-oncology combos with Merck KGaA

    Pfizer Inc. (NYSE:PFE) is betting it can jump to frontrunner status with combination immunotherapies for cancer on the back of Monday's agreement to co-develop and co-commercialize its portfolio of immuno-oncology …

    Published on 11/17/2014
  • COMPANY NEWS: FDA adds ovarian cancer to Avastin's label

    FDA approved an sBLA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Avastin bevacizumab to treat recurrent platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in …

    Published on 11/14/2014
  • COMPANY NEWS: Janssen licenses Geron's imetelstat

    Geron Corp. (NASDAQ:GERN) gained $0.45 (19%) to $2.76 on Friday after it granted the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) exclusive, worldwide rights to develop and commercialize imetelstat, an …

    Published on 11/14/2014
  • COMPANY NEWS: VC tracks

    5AM Ventures named Brian Daniels a venture partner and Stephen Bonelli as CFO. Daniels was SVP of global development and medical affairs at Bristol-Myers Squibb Co. (NYSE:BMY). Bonelli was CFO at Three Arch Partners. …

    Published on 11/14/2014
  • COMPANY NEWS: Revance falls on Phase III delay

    Dermatology play Revance Therapeutics Inc. (NASDAQ:RVNC) plunged $4.93 (23%) to $16.07 on Thursday after it said it would not start a pivotal Phase III trial of lead candidate RT001 to treat canthal lines (crow's feet),…

    Published on 11/13/2014
  • COMPANY NEWS: Precision Therapeutics recaps, now Helomics

    Oncology diagnostics play Helomics Corp. (Pittsburgh, Pa.) recapitalized with a $60 million investment from HealthCare Royalty Partners and changed its name from Precision Therapeutics Inc. The company also named as its…

    Published on 11/12/2014
  • COMPANY NEWS: Alnylam adds to hepatic pipeline

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) unveiled two new RNAi therapeutic candidates in its hepatic infectious diseases portfolio at the American Association for the Study of Liver Diseases (AASLD) meeting.The …

    Published on 11/11/2014
  • COMPANY NEWS: Ascletis gets China license for Presidio HCV candidate

    Presidio Pharmaceuticals Inc. (San Francisco, Calif.) granted Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) exclusive development and commercialization rights to HCV candidate PPI-668 in China, Taiwan, Hong Kong …

    Published on 11/11/2014
  • COMPANY NEWS: FDA accepts Amgen's evolocumab BLA

    FDA accepted for review a BLA from Amgen Inc. (NASDAQ:AMGN) for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9, to treat high cholesterol. The application is the first in the U.S…

    Published on 11/10/2014
  • COMPANY NEWS: Orexigen jumps on Contrave Direct(ion)

    Orexigen Therapeutics Inc. (NASDAQ:OREX) surged $1.28 (33%) to $5.13 on Monday as investors welcomed the company's 3Q14 earnings call comments that it had "underestimated" the demand for the Direct Save Program for …

    Published on 11/10/2014

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