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Chronological Index of : Company News

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  • COMPANY NEWS: Janssen submits sirukumab BLA

    The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) submitted a BLA to FDA for sirukumab (CNTO 136) to treat moderately to severely active rheumatoid arthritis in adults who have failed or are intolerant to …

    Published on 9/23/2016
  • COMPANY NEWS: Management tracks

    Zambon Co. S.p.A. (Milan, Italy), which develops CNS, respiratory and pain therapies, named Roberto Tascione CEO. He was president and CEO for Italy at Bristol-Myers Squibb Co. (NYSE:BMY). Generics company Endo …

    Published on 9/23/2016
  • COMPANY NEWS: NICE backs Gilead's Epclusa

    In draft guidance, the U.K.'s NICE recommended Epclusa sofosbuvir/velpatasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat all genotypes of chronic HCV. The recommendation is contingent on Gilead providing the drug …

    Published on 9/23/2016
  • COMPANY NEWS: Newron re-submits Xadago NDA

    Newron Pharmaceuticals S.p.A. (SIX:NWRN) re-submitted an NDA to FDA for Parkinson's disease candidate Xadago safinamide. In March, FDA issued a complete response letter for Xadago as an add-on therapy for early and mid …

    Published on 9/22/2016
  • COMPANY NEWS: NICE backs Strensiq for some HPP patients

    The U.K.'s NICE issued draft guidance recommending approval of Strensiq asfotase alfa from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat the bone manifestations of perinatal- and infantile-onset hypophosphatasia …

    Published on 9/22/2016
  • COMPANY NEWS: PharmaMar submits Aplidin MAA

    PharmaMar S.A. (Madrid:PHM) submitted an MAA to EMA for Aplidin plitidepsin in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM). In March, the company said the candidate significantly…

    Published on 9/22/2016
  • COMPANY NEWS: uniQure CEO Soland resigns

    Gene therapy company uniQure N.V. (NASDAQ:QURE) said CEO Daniel Soland resigned "due solely to personal family reasons." CFO Matthew Kapusta will be interim CEO, and will remain CFO. uniQure said it will not yet start a…

    Published on 9/22/2016
  • COMPANY NEWS: UnitedHealth excludes Lantus, Neupogen from 2017 drug list

    UnitedHealth Group Inc. (NYSE:UNH) will remove Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) and Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN) from its 2017 Prescription Drug List, substituting follow…

    Published on 9/22/2016
  • COMPANY NEWS: bluebird's LentiGlobin gets EMA's PRIME designation

    bluebird Bio Inc. (NASDAQ:BLUE) said EMA accepted gene therapy candidate LentiGlobin BB305 into its PRIority MEdicines (PRIME) scheme as a treatment for transfusion-dependent beta-thalassemia. The pathway was launched …

    Published on 9/21/2016
  • COMPANY NEWS: Evotec, Bayer partner in kidney disease

    Evotec AG (Xetra:EVT) and Bayer AG (Xetra:BAYN) began a five-year collaboration to develop treatments for kidney diseases, including chronic kidney disease in diabetes patients. Bayer will pay EUR 14 million ($15.6 …

    Published on 9/21/2016
  • COMPANY NEWS: Genentech, BioNTech in personalized vaccine deal

    The Genentech Inc. unit of Roche (SIX:ROG;OTCQX:RHHBY) and BioNTech AG (Mainz, Germany) partnered to develop and commercialize personalized mRNA-based immunotherapies that target patient neoantigens to treat a variety …

    Published on 9/21/2016
  • COMPANY NEWS: Moderna building $110M manufacturing plant

    Moderna Therapeutics Inc. (Cambridge, Mass.) is spending $110 million to build a 200,000-square foot GMP manufacturing plant in Norwood, Mass., where it intends to manufacture clinical-grade mRNA therapies and vaccines.…

    Published on 9/21/2016
  • COMPANY NEWS: Viventia finds public path via Eleven

    Ophthalmic therapeutics company Eleven Biotherapeutics Inc. (NASDAQ:EBIO) acquired cancer company Viventia Bio Inc. (Mississauga, Ontario), which had been in the IPO queue. The combined company will retain Eleven's name…

    Published on 9/21/2016
  • COMPANY NEWS: FDA reviewing Puma's neratinib

    Puma Biotechnology Inc. (NYSE:PBYI) gained $6.21 (11%) to $65.16 on Tuesday after it said FDA accepted an NDA for oral neratinib (PB272) to treat patients with early stage HER2-amplified breast cancer previously treated…

    Published on 9/20/2016
  • COMPANY NEWS: GSK names Walmsley to succeed Witty

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Emma Walmsley will succeed Sir Andrew Witty as CEO on March 31, 2017. Walmsley is CEO of GSK's Consumer Healthcare division.GSK said in March that Witty planned to retire. He…

    Published on 9/20/2016
  • COMPANY NEWS: Regeneron, Teva in deal for pain candidate fasinumab

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) will pay Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) $250 million up front in a deal to jointly develop and commercialize Regeneron's pain candidate fasinumab (REGN475). …

    Published on 9/20/2016
  • COMPANY NEWS: Shire returns rights to CTI's pacritinib

    Shire plc (LSE:SHP; NASDAQ:SHPG) terminated a license agreement with CTI Biopharma Corp. (NASDAQ:CTIC; Milan:CTIC) and returned worldwide development and commercialization rights to myelofibrosis candidate pacritinib (…

    Published on 9/20/2016
  • COMPANY NEWS: Amgen pushes for access to biosimilar information

    In an appellate brief filed in federal court, Amgen Inc. (NASDAQ:AMGN) said a U.S. District Court's failure to force the Hospira Inc. unit of Pfizer Inc. (NYSE:PFE) to supply manufacturing information for a biosimilar "…

    Published on 9/19/2016
  • COMPANY NEWS: Sanofi suit: Merck's follow-on biologic infringes Lantus patents

    In a suit filed in federal court, Sanofi (Euronext:SAN; NYSE:SNY) alleged Merck & Co. Inc. (NYSE:MRK) infringed 10 of its patents covering the pharma's Lantus insulin glargine and Lantus SoloStar pen.Last month, Merck …

    Published on 9/19/2016
  • COMPANY NEWS: CHMP reverses on Ninlaro, also backs Lartruvo, Ibrance

    EMA's CHMP recommended approval of three cancer medicines on Friday, including a reversal of opinion for multiple myeloma (MM) drug Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). The committee …

    Published on 9/16/2016
  • COMPANY NEWS: Depomed rises on takeout rumors

    Pain company Depomed Inc. (NASDAQ:DEPO) gained $3.10 (15%) to $24.34 on Friday after media reports said the company was preparing for a sale. Depomed spokesperson Christopher Keenan declined to comment on the …

    Published on 9/16/2016
  • COMPANY NEWS: Management tracks

    EMA said Head of International Affairs Emer Cooke will leave the agency to join the World Health Organization as head of regulation of medicines and other health technologies in WHO's essential medicines and health …

    Published on 9/16/2016
  • COMPANY NEWS: Novavax plummets after Phase III failure

    Novavax Inc. (NASDAQ:NVAX) sank $7.05 (85%) to $1.29 on Friday after its RSV F vaccine failed in the Phase III Resolve trial to treat respiratory syncytial virus (RSV) infection in elderly adults. Novavax announced the …

    Published on 9/16/2016
  • COMPANY NEWS: Eisai's Kisplyx approved in EU for kidney cancer

    The European Commission approved Kisplyx lenvatinib from Eisai Co. Ltd. (Tokyo:4523) in combination with Afinitor everolimus to treat advanced renal cell carcinoma (RCC) in patients previously treated with a VEGF …

    Published on 9/15/2016
  • COMPANY NEWS: FDA approves Aralez's Yosprala

    Aralez Pharmaceuticals Inc. (NASDAQ:ARLZ; TSX:ARZ) said FDA approved an NDA for Yosprala 325/40 (PA32540) and Yosprala 81/40 (PA8140) to prevent cardiovascular and cerebrovascular events in patients who require aspirin …

    Published on 9/15/2016

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