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  • COMPANY NEWS: FDA briefing docs rebuff MoxDuo IR

    FDA's Bob Rappaport said the agency's review team has been "unable to conclude that there is a safety benefit" for MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY), which is under review to treat …

    Published on 4/18/2014
  • COMPANY NEWS: FDA committee to discuss olaparib

    FDA's Oncologic Drugs Advisory Committee will meet on June 25 to discuss an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for olaparib as maintenance treatment of platinum-sensitive relapsed ovarian cancer. The pharma …

    Published on 4/18/2014
  • COMPANY NEWS: FDA approves Arzerra for first-line CLL

    FDA approved an sBLA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanding the label for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The new indication covers the use of …

    Published on 4/17/2014
  • COMPANY NEWS: 23andMe hires Hagenkord as CMO

    Personal genomics company 23andMe Inc. (Mountain View, Calif.) hired Jill Hagenkord as CMO, a newly created position. She was SVP of medical strategy at genetic diagnostics company Invitae Corp. (San Francisco, Calif.).…

    Published on 4/16/2014
  • COMPANY NEWS: BioAlliance to merge with Topotarget

    Cancer companies BioAlliance Pharma S.A. (Euronext:BIO) and Topotarget A/S (CSE:TOPO) will merge in a stock deal to create a company focused on Orphan cancers. Topotarget shareholders will own about a third of the …

    Published on 4/16/2014
  • COMPANY NEWS: Court temporarily halts Massachusetts Zohydro ban

    A judge in the U.S. District Court for the District of Massachusetts granted a preliminary injunction stopping Massachusetts' statewide ban on pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX).…

    Published on 4/15/2014
  • COMPANY NEWS: FDA approves GSK's albiglutide

    FDA approved Tanzeum albiglutide from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat Type II diabetes as monotherapy or as add-on therapy. GSK plans to launch Tanzeum in the U.S. next quarter, but declined to comment …

    Published on 4/15/2014
  • COMPANY NEWS: Germany again rebuffs Trobalt

    Germany's Federal Joint Committee (G-BA) again concluded that epilepsy drug Trobalt retigabine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has "no additional benefit" vs. individualized antiepileptic therapy. According…

    Published on 4/15/2014
  • COMPANY NEWS: IQWiG rebuffs Novo's NovoEight

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that NovoEight turoctocog alfa from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) has "no additional benefit" vs. …

    Published on 4/15/2014
  • COMPANY NEWS: NICE recommends ESAs for cancer treatment anemia

    The U.K.'s NICE issued draft guidance that now recommends erythropoietin-stimulating agents (ESAs) epoetin and darbepoetin to treat cancer treatment-associated anemia. NICE said the most plausible incremental cost-…

    Published on 4/15/2014
  • COMPANY NEWS: Prosonix, Mylan in generic respiratory deal

    Prosonix Ltd. (Oxford, U.K.) granted Mylan Inc. (NASDAQ:MYL) rights to market generic versions of asthma product Flixotide/Flovent from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in several regions, including the U.S., EU,…

    Published on 4/15/2014
  • COMPANY NEWS: WuXi snags AZ's Yang as COO

    WuXi PharmaTech Inc. (NYSE:WX) hired Steve Yang as EVP and COO. Yang was VP and head of the Asia and emerging markets innovative medicines unit (iMED) at AstraZeneca plc (LSE:AZN; NYSE:AZN). He succeeds Edward Hu, who …

    Published on 4/15/2014
  • COMPANY NEWS: Almirall pulling Constella in Germany

    Almirall S.A. (Madrid:ALM) said it will no longer market Constella linaclotide in Germany after failing to agree on a price with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband). In October, …

    Published on 4/14/2014
  • COMPANY NEWS: Bristol-Myers submits atazanavir/cobicistat NDA

    Bristol-Myers Squibb Co. (NYSE:BMY) submitted an NDA to FDA for a fixed-dose combination of its HIV drug Reyataz atazanavir and cobicistat from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in combination …

    Published on 4/14/2014
  • COMPANY NEWS: Court hears motion in Zohydro case

    On Monday, the U.S. District Court for the District of Massachusetts heard a motion from Zogenix Inc. (NASDAQ:ZGNX) seeking a temporary restraining order to stay Massachusetts Gov. Deval Patrick's ban on pain drug …

    Published on 4/14/2014
  • COMPANY NEWS: FDA accepts resubmitted Iluvien NDA

    Alimera Sciences Inc. (NASDAQ:ALIM) said FDA accepted for review a resubmitted NDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME). The PDUFA date is Sept. 26. In October, …

    Published on 4/14/2014
  • COMPANY NEWS: FDA approves Grastek

    FDA approved a BLA for Grastek, a grass pollen sublingual allergy immunotherapy tablet (AIT) from Merck & Co. Inc. (NYSE:MRK) to treat grass pollen-induced allergic rhinitis, with or without conjunctivitis. The pharma …

    Published on 4/14/2014
  • COMPANY NEWS: Novartis 'significantly' reducing discovery for RNA therapeutics

    Novartis AG (NYSE:NVS; SIX:NOVN) said it will "significantly reduce" its internal discovery efforts in RNA therapeutics due to "ongoing challenges with formulation and delivery and the reality that the current range of …

    Published on 4/14/2014
  • COMPANY NEWS: Scripps launches initiative to fund early stage projects

    The Scripps Research Institute launched Scripps Advance to identify and invest in early stage biomedical research projects. Under the initiative, Scripps Advance will partner with pharmas to select and fund projects …

    Published on 4/14/2014
  • COMPANY NEWS: CDC continues to recommend Tamiflu, Relenza

    The U.S. Centers for Disease Control and Prevention said it continues to recommend the use of Tamiflu oseltamivir and Relenza zanamivir to treat influenza. The recommendation came in response to an updated review of the…

    Published on 4/11/2014
  • COMPANY NEWS: Impax resubmits Rytary NDA

    Impax Laboratories Inc. (NASDAQ:IPXL) resubmitted an NDA to FDA for Rytary extended-release carbidopa/levodopa for the symptomatic treatment of Parkinson's disease (PD). The company said the NDA contains updated safety …

    Published on 4/11/2014
  • COMPANY NEWS: U.K. court invalidates European Herceptin patents

    The Chancery Division of England's High Court of Justice invalidated two European patents covering breast cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OCTQX:RHHBY) and its Genentech Inc. unit. Hospira Inc. (…

    Published on 4/11/2014
  • COMPANY NEWS: Biogen Idec hires Koppel as chief strategy officer

    Biogen Idec Inc. (NASDAQ:BIIB) hired Adam Koppel as SVP and chief strategy officer, a newly created role, effective May 15. Koppel was a managing director at Brookside Capital, the public equity affiliate of Bain …

    Published on 4/10/2014
  • COMPANY NEWS: Chugai seeks Japanese approval of Zelboraf

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Zelboraf vemurafenib to treat BRAF V600 mutation-positive melanoma. Chugai has Japanese rights to …

    Published on 4/9/2014
  • COMPANY NEWS: Spero, Roche in infectious disease deal

    Infectious disease play Spero Therapeutics LLC (Cambridge, Mass.) granted Roche (SIX:ROG; OCTQX:RHHBY) the exclusive option to acquire Spero's lead antibiotic program, a preclinical inhibitor of an undisclosed target in…

    Published on 4/9/2014

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