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  • COMPANY NEWS: Regeneron's Eylea gets breakthrough designation

    FDA granted breakthrough therapy designation to Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic retinopathy in patients with diabetic macular edema (DME). Regeneron plans to submit …

    Published on 9/16/2014
  • COMPANY NEWS: FDA approves Baxter's HyQvia for primary immunodeficiency

    FDA approved HyQvia from Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics Inc. (NASDAQ:HALO) to treat adults with primary immunodeficiency (PI).HyQvia is a subcutaneous formulation of Gammagard, an IgG …

    Published on 9/15/2014
  • COMPANY NEWS: Gilead licenses HCV drugs to Indian generic makers

    Gilead Sciences Inc. (NASDAQ:GILD) signed non-exclusive licensing agreements allowing seven Indian generics companies to manufacture its chronic HCV drugs sofosbuvir and sofosbuvir/ledipasvir for distribution in 91 …

    Published on 9/15/2014
  • COMPANY NEWS: GSK exercises option from Five Prime

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) exercised its option to license drug candidates discovered as part of a 2010 deal with Five Prime Therapeutics Inc. (NASDAQ:FPRX). GSK took exclusive rights to an undisclosed …

    Published on 9/15/2014
  • COMPANY NEWS: India approves Epirus' Remicade biosimilar

    The Drug Controller General of India (DCGI) approved manufacturing and marketing of autoimmune therapy Infimab infliximab from Epirus Biopharmaceuticals Inc. (NASDAQ:EPRS).Infimab, formerly BOW015, is India's first …

    Published on 9/15/2014
  • COMPANY NEWS: NPS drops 17% on Natpara vote

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP) lost $5.42 (17%) to $27.29 on Monday after FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Natpara for hypoparathyroidism by an 8-5 vote…

    Published on 9/15/2014
  • COMPANY NEWS: Calico gains P7C3 neurodegeneration program

    2M BioTech L.P. (Dallas, Texas) granted Calico LLC (South San Francisco, Calif.) exclusive, worldwide rights to develop and commercialize a portfolio of modulators of nicotinamide phosphoribosyl transferase (NamPRT; …

    Published on 9/11/2014
  • COMPANY NEWS: IQWiG: Olysio offers 'major' benefit vs. Incivek

    Germany's Institute for Quality and Efficiency in Healthcare said HCV drug Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) offers "major" additional benefit over Incivek telaprevir in …

    Published on 9/11/2014
  • COMPANY NEWS: Novartis, Penn reveal CACT plans

    The University of Pennsylvania and Novartis AG (SIX:NOVN; NYSE:NVS) unveiled plans on Thursday to build the Center for Advanced Cellular Therapeutics (CACT) to accelerate the discovery, development and manufacturing of …

    Published on 9/11/2014
  • COMPANY NEWS: Orexigen sinks on Contrave postapproval details

    Orexigen Therapeutics Inc. (NASDAQ:OREX) was off $0.62 (11%) to $5.28 on Thursday after the biotech said it would fund the postapproval cardiovascular outcomes trial requested by FDA for Contrave naltrexone/bupropion. …

    Published on 9/11/2014
  • COMPANY NEWS: Oxygen slides on Oxycyte trial halt

    Oxygen Biotherapeutics Inc. (NASDAQ:OXBT) fell $0.36 to $3.70 in early after-hours trading on Thursday after announcing it would halt a Phase IIb trial evaluating Oxycyte to treat traumatic brain injury. Oxygen said it …

    Published on 9/11/2014
  • COMPANY NEWS: Roche drops Phase II Fragile X program

    Roche (SIX:ROG; OTCQX:RHHBY) said it will discontinue development of RG7090 to treat Fragile X syndrome, for which the negative modulator of metabotropic glutamate receptor subtype 5 (mGluR5; GRM5) was in Phase II …

    Published on 9/11/2014
  • COMPANY NEWS: EC approves Lantus biosimilar

    The European Commission approved Abasria insulin glargine from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and II diabetes. The basal insulin glargine analog was …

    Published on 9/10/2014
  • COMPANY NEWS: FDA approves Xtandi for chemotherapy-naïve CRPC

    FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) to expand the label of Xtandi enzalutamide to include treatment of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC…

    Published on 9/10/2014
  • COMPANY NEWS: FDA panel rebuffs Actavis' nebivolol/valsartan

    FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis plc (NYSE:ACT) for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a …

    Published on 9/10/2014
  • COMPANY NEWS: FDA reviewers say Natpara is effective

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP) stock jumped $6.47 (25%) to $32.24 on Wednesday after FDA reviewers concluded that once-daily subcutaneous injections of Natpara reduced the need for calcium and vitamin D …

    Published on 9/10/2014
  • COMPANY NEWS: Clal, Evotec fall on DiaPep277 revelations

    Clal Biotechnology Industries Ltd. (Tel Aviv:CBI) plummeted NIS366.80 (46%) to NIS440 on Tuesday, a day after Hyperion Therapeutics Inc. (NASDAQ:HPTX) said it is terminating diabetes candidate DiaPep277 following …

    Published on 9/9/2014
  • COMPANY NEWS: Court rules against Hospira on generic Precedex

    The U.S. District Court for the District of Maryland sided with FDA in a suit challenging whether the agency could approve generic versions of a sedative so long as the generic labels do not include an approved use …

    Published on 9/8/2014
  • COMPANY NEWS: FDA to review isavuconazole

    FDA accepted for review an NDA from Astellas Pharma Inc. (Tokyo:4503) for isavuconazole (BAL8557) to treat invasive aspergillosis and mucormycosis (zygomycosis). The PDUFA date is March 8, 2015. The acceptance triggers …

    Published on 9/8/2014
  • COMPANY NEWS: J&J, U of Toronto in neuroscience deal

    The Janssen Biotech Inc. subsidiary of Johnson & Johnson (NYSE:JNJ) partnered with the University of Toronto's Center for Collaborative Drug Research (CCDR) to develop therapies to treat mood disorders and Alzheimer's …

    Published on 9/8/2014
  • COMPANY NEWS: NICE rebuffs Abraxane for pancreatic cancer

    The U.K.'s NICE issued draft guidance recommending against the use of Abraxane nab-paclitaxel from Celgene Corp. (NASDAQ:CELG) for first-line treatment of metastatic pancreatic cancer in combination with gemcitabine -- …

    Published on 9/8/2014
  • COMPANY NEWS: Scandal craters Hyperion's DiaPep277

    Hyperion Therapeutics Inc. (NASDAQ:HPTX) said it is terminating diabetes candidate DiaPep277 following research misconduct -- a move that comes just three months after Hyperion spent about $20.4 million to acquire …

    Published on 9/8/2014
  • COMPANY NEWS: Tesaro submits NDA for oral rolapitant

    Tesaro Inc. (NASDAQ:TSRO) submitted an NDA to FDA for oral rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV). The company has exclusive, worldwide rights to the neurokinin 1 (NK1) Substance P …

    Published on 9/8/2014
  • COMPANY NEWS: FDA accepts ceftazidime/avibactam NDA

    Actavis plc (NYSE:ACT) said FDA accepted for review an NDA for ceftazidime/avibactam (CAZ-104) to treat complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). The PDUFA date is …

    Published on 9/5/2014
  • COMPANY NEWS: FDA approves Keryx's ferric citrate

    FDA approved ferric citrate from Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) to treat hyperphosphatemia in dialysis-dependent patients with chronic kidney disease (CKD). FDA contraindicated the drug in patients with …

    Published on 9/5/2014

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