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  • COMPANY NEWS: Pfizer creates gene therapy unit, strikes Spark deal

    Pfizer Inc. (NYSE:PFE) launched a gene therapy unit within its rare disease research area and unveiled a deal with Spark Therapeutics LLC (Philadelphia, Pa.) to develop gene therapies to treat hemophilia B. The pharma …

    Published on 12/8/2014
  • COMPANY NEWS: Sandoz rebuffed again in biosimilar suit against Amgen

    A U.S. appeals court dismissed on procedural grounds a patent suit filed by the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) against Amgen Inc. (NASDAQ:AMGN) and Roche (SIX:ROG; OTCQX:RHHBY) concerning Sandoz's …

    Published on 12/8/2014
  • COMPANY NEWS: GSK staying put with established products

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) dropped its plan to divest a portfolio of U.S. and European established products after evaluating bids from potential buyers. GSK spokesperson Melinda Stubbee declined to provide …

    Published on 12/5/2014
  • COMPANY NEWS: Juno licenses CAR therapy from Opus Bio

    Juno Therapeutics Inc. (Seattle, Wash.) licensed from Opus Bio Inc. (Greenwich, Conn.) a candidate that uses chimeric antigen receptor (CAR) technology to target CD22. Financial terms were not disclosed and both …

    Published on 12/5/2014
  • COMPANY NEWS: Mixed recommendation for Actavis' ceftazidime/avibactam

    FDA's Anti-Infective Drugs Advisory Committee (AIDAC) recommended approval of ceftazidime/avibactam (CAZ-104) from Actavis plc (NYSE:ACT) to treat two forms of complicated infections, but rebuffed the compound's use in …

    Published on 12/5/2014
  • COMPANY NEWS: FDA approves Jakafi for polycythemia vera

    FDA approved an sNDA under Priority Review for Jakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) to treat patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. …

    Published on 12/4/2014
  • COMPANY NEWS: IQWiG: Selincro's benefit to heavy drinkers unproven

    The German Institute for Quality and Efficiency in Health Care (IQWiG) said H. Lundbeck A/S (CSE:LUN) did not show Selincro nalmefene offered benefit over comparator naltrexone to reduce alcohol consumption by adults …

    Published on 12/4/2014
  • COMPANY NEWS: Whistleblower suit alleges Sanofi kickback scheme

    A former employee of Sanofi (Euronext:SAN; NYSE:SNY) filed a lawsuit alleging that former CEO Christopher Viehbacher and other company executives and managers disbursed $34 million through consultants Accenture and …

    Published on 12/4/2014
  • COMPANY NEWS: GSK cuts jobs in U.S. restructuring

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it will lay off an unspecified number of U.S. employees in both R&D and commercial operations by YE2015.GSK said most layoffs will occur among its drug discovery, development…

    Published on 12/3/2014
  • COMPANY NEWS: Illumina, Sequenom settle suit

    Illumina Inc. (NASDAQ:ILMN) said it will pay $50 million to Sequenom Inc. (NASDAQ:SQNM) to settle ongoing patent infringement claims related to the companies' nucleic acid analysis technologies for non-invasive prenatal…

    Published on 12/3/2014
  • COMPANY NEWS: Indication switch for neratinib delays Puma NDA

    Puma Biotechnology Inc. (NYSE:PBYI) sank $27.33 (12%) to $197.67 on Wednesday on news the company will delay submitting an NDA for neratinib until 1Q16.The delay is based on the company's decision to seek approval of …

    Published on 12/3/2014
  • COMPANY NEWS: Speedy approval for Amgen's Blincyto

    FDA granted accelerated approval to Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) to treat Philadelphia chromosome-negative precursor B cell acute lymphoblastic leukemia (ALL), well ahead of its May 19, 2015 PDUFA…

    Published on 12/3/2014
  • COMPANY NEWS: 23andMe launches genome service in the U.K.

    23andMe Inc. (Mountain View, Calif.) launched its Personal Genome Service (PGS) in the U.K. Last year, 23andMe halted sales of the service in the U.S. after an FDA warning letter said 23andMe was marketing its product …

    Published on 12/2/2014
  • COMPANY NEWS: Astellas, Janssen end autoimmune deal

    The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) terminated its 2012 deal with Astellas Pharma Inc. (Tokyo:4503) for autoimmune disease treatment ASP015K. Janssen, which had licensed ex-Japanese rights to …

    Published on 12/2/2014
  • COMPANY NEWS: Epirus, Ranbaxy launch Remicade biosimilar

    Epirus Biopharmaceuticals Inc. (NASDAQ:EPRS) and partner Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359) launched Infimab infliximab in India. Infimab is the first biosimilar of Remicade infliximab from Johnson & …

    Published on 12/2/2014
  • COMPANY NEWS: Roche acquires Ariosa Diagnostics

    Roche (SIX:ROG; OTCQX:RHHBY) acquired Ariosa Diagnostics Inc. (San Jose, Calif.) for an undisclosed sum. Ariosa makes the Harmony Prenatal Test, a non-invasive prenatal multiplex assay that detects fetal trisomies 13, …

    Published on 12/2/2014
  • COMPANY NEWS: Servier takes option on GeNeuro's MS therapy

    GeNeuro S.A. (Geneva, Switzerland) granted Servier (Neuilly-sur-Seine, France) an option to license worldwide rights, excluding the U.S. and Japan, to GNbAC1 to treat multiple sclerosis (MS).Servier will pay GeNeuro $47…

    Published on 12/2/2014
  • COMPANY NEWS: Editas scores hat trick of CRISPR-Cas9 deals

    Editas Medicine (Cambridge, Mass.) obtained exclusive licenses to CRISPR-Cas9 and TALEN gene editing technologies from three research institutions.Two of the new agreements involved Editas' own scientific co-founders: …

    Published on 12/1/2014
  • COMPANY NEWS: NICE now recommends Roche's Gazyvaro for CLL

    The U.K.'s NICE issued final draft guidance recommending Gazyvaro obinutuzumab from Roche (SIX:ROG; OTCQX:RHHBY) in combination with chlorambucil as first-line therapy for chronic lymphocytic leukemia (CLL) in patients …

    Published on 12/1/2014
  • COMPANY NEWS: Pozen, Sanofi end deal for omeprazole/aspirin combo

    Sanofi (Euronext:SAN; NYSE:SNY) returned to Pozen Inc. (NASDAQ:POZN) U.S. rights to omeprazole/aspirin combinations PA32540 and PA8140 as the parties terminated a September 2013 deal."The regulatory timeline has taken …

    Published on 12/1/2014
  • COMPANY NEWS: UnitedHealth rebuffs Cologuard

    UnitedHealth Group Inc. (NYSE:UNH) on Monday instituted a medical policy that concludes the evidence is insufficient to support the diagnostic accuracy of fecal DNA tests to screen for colorectal cancer in asymptomatic,…

    Published on 12/1/2014
  • 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

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