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  • 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    The U.K.'s NICE issued draft guidance that now recommends erythropoietin-stimulating agents (ESAs) epoetin and darbepoetin to treat cancer treatment-associated anemia.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
  • COMPANY NEWS: Takeda slips on $9 billion Actos judgment

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) fell Y249 to Y4,572 on Tuesday after a U.S. jury ordered the pharma to pay $6 billion in punitive damages for failing to adequately warn of a risk of bladder cancer associated…

    Published on 4/8/2014
  • COMPANY NEWS: BMS submits daclatasvir, asunaprevir NDAs

    Bristol-Myers Squibb Co. (NYSE:BMY) submitted a pair of NDAs to FDA for daclatasvir (BMS-790052) and asunaprevir (BMS-650032) to treat HCV genotype Ib infection. The NDAs support the use of the compounds in combination,…

    Published on 4/7/2014
  • COMPANY NEWS: MannKind slips on Afrezza PDUFA extension

    MannKind Corp. (NASDAQ:MNKD) slipped $0.55 to $6.32 on Monday after FDA extended by three months the PDUFA date for a resubmitted NDA for Afrezza to improve glycemic control in Type I and II diabetics. The new PDUFA …

    Published on 4/7/2014
  • COMPANY NEWS: Oryzon licenses LSD1 inhibitors to Roche

    Oryzon Genomics S.A. (Barcelona, Spain) granted Roche (SIX:ROG; OTCQX:RHHBY) exclusive, worldwide rights to develop and commercialize a program of inhibitors of lysine-specific demethylase 1 (KDM1A; LSD1) with a primary…

    Published on 4/7/2014
  • COMPANY NEWS: Priority Review for Gilead's sofosbuvir/NS5A combo

    Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review for an NDA for an oral, once-daily, fixed-dose combination of the company's HCV drug Sovaldi sofosbuvir and ledipasvir (GS-5885) to treat …

    Published on 4/7/2014
  • COMPANY NEWS: Roche to acquire IQuum

    Roche (SIX:ROG; OTCQX:RHHBY) will acquire molecular diagnostics company IQuum Inc. (Marlborough, Mass.) for $275 million in cash up front and up to $175 million in milestones. Roche will gain IQuum's Liat Analyzer …

    Published on 4/7/2014
  • COMPANY NEWS: Sun to acquire Ranbaxy

    Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) will acquire fellow Indian generics company Ranbaxy Laboratories Ltd. (BSE:500359; NSE:RANBAXY) in an all-stock deal that the companies said values Ranbaxy …

    Published on 4/7/2014

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