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Chronological Index of : Company News

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  • COMPANY NEWS: CRL for daclatasvir sets back BMS's HCV program

    Bristol-Myers Squibb Co. (NYSE:BMY) said FDA issued a complete response letter for daclatasvir on Wednesday, requesting additional safety and efficacy data for the HCV drug in combination with other antiviral agents. …

    Published on 11/26/2014
  • COMPANY NEWS: FDA extends review of Novartis' panobinostat

    FDA will extend by up to three months its review of an NDA for panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN). The agency granted Priority Review in May to the oral pan-deacetylase (DAC) inhibitor in combination …

    Published on 11/25/2014
  • COMPANY NEWS: NICE recommends Selincro for alcohol dependence

    The U.K.'s NICE issued final guidance recommending the use of Selincro nalmefene from H. Lundbeck A/S (CSE:LUN) to reduce alcohol consumption by adults with alcohol dependence who have a high drinking risk level without…

    Published on 11/25/2014
  • COMPANY NEWS: Five Prime, BMS to study PD-1, CSF1R combo

    Bristol-Myers Squibb Co. (NYSE:BMY) and Five Prime Therapeutics Inc. (NASDAQ:FPRX) will jointly evaluate a combination of BMS's Opdivo nivolumab and Five Prime's FPA008 in a Phase Ia/Ib study to treat non-small cell …

    Published on 11/24/2014
  • COMPANY NEWS: J&J, Transposagen partner to develop CAR T therapies

    The Janssen unit of Johnson & Johnson (NYSE:JNJ) and Transposagen Biopharmaceuticals Inc. (Lexington, Ky.) have started a three-year research collaboration to develop allogeneic CAR T therapies using Transposagen's …

    Published on 11/24/2014
  • COMPANY NEWS: Juno's JCAR015 gets breakthrough designation in ALL

    FDA granted breakthrough therapy designation to JCAR015 from Juno Therapeutics Inc. (Seattle, Wash.) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Juno partner Memorial Sloan Kettering…

    Published on 11/24/2014
  • COMPANY NEWS: Lundbeck CEO steps down

    H. Lundbeck A/S (CSE:LUN) CEO Ulf Wiinberg resigned after failing to disclose that he received 55 shares of Stratified Medical Ltd. (London, U.K.) from the company's founder in 2013. Lundbeck later invested DKK19 …

    Published on 11/24/2014
  • COMPANY NEWS: Merck licenses NewLink's Ebola vaccine

    Merck & Co. Inc. (NYSE:MRK) has paid $30 up front for exclusive worldwide rights to develop and commercialize the Ebola vaccine VSV-EBOV from NewLink Genetics Corp. (NASDAQ:NLNK). The biotech also will receive $20 …

    Published on 11/24/2014
  • COMPANY NEWS: Yondelis finally back to FDA

    The Janssen Research & Development unit of Johnson & Johnson (NYSE:JNJ) submitted an NDA for Yondelis trabectedin to treat patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.The …

    Published on 11/24/2014
  • 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

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