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Chronological Index of : Company News

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  • COMPANY NEWS: Endo bids $2.2B for Auxilium

    Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire fellow specialty pharma Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for $28.10 per share in cash and stock, or about $2.2 billion. The …

    Published on 9/16/2014
  • COMPANY NEWS: FDA approves AZ's Movantik for OIC

    FDA approved an NDA for once-daily Movantik naloxegol from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. AZ plans to launch the pegylated form of …

    Published on 9/16/2014
  • COMPANY NEWS: FDA panel to discuss Daiichi Sankyo's Savaysa

    FDA's Cardiovascular and Renal Drugs advisory committee will meet on Oct. 30 to discuss an NDA from Daiichi Sankyo Co. Ltd. (Tokyo:4568) for Savaysa edoxaban to prevent stroke and systemic embolic events in patients …

    Published on 9/16/2014
  • COMPANY NEWS: Jenkins joins Dimension as CEO

    Dimension Therapeutics (Cambridge, Mass.) hired Annalisa Jenkins as CEO. She previously was EVP and head of global R&D at the Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK). Jenkins succeeds …

    Published on 9/16/2014
  • COMPANY NEWS: Lilly buys into AZ's BACE for Alzheimer's

    Eli Lilly and Co. (NYSE:LLY) will pay up to $500 million to AstraZeneca plc (LSE:AZN; NYSE:AZN) under a deal for the pharmas to jointly develop and commercialize AZ's AZD3293 for Alzheimer's disease.The partners said …

    Published on 9/16/2014
  • COMPANY NEWS: Merck Serono, Lupin in emerging markets deal

    The Merck Serono S.A. biopharmaceutical division of Merck KGaA (Xetra:MRK) partnered with Lupin Ltd. (NSE:LUPIN; BSE:500257) to develop and commercialize up to 20 general medicines in emerging markets. Lupin will …

    Published on 9/16/2014
  • 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

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