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  • COMPANY NEWS: Boehringer, ViraTherapeutics in oncolytic virus deal

    Boehringer Ingelheim GmbH (Ingelheim, Germany) partnered with oncolytic virus play ViraTherapeutics GmbH (Innsbruck, Austria) to jointly develop ViraTherapeutics' oncolytic virus therapy platform and its lead candidate,…

    Published on 9/28/2016
  • COMPANY NEWS: Cigna covering Exondys 51

    Cigna Corp. (NYSE:CI) will cover Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy (DMD) "in patients who have a confirmed mutation of a specific section of the DMD …

    Published on 9/28/2016
  • COMPANY NEWS: FDA approves first 'artificial pancreas' for Type I diabetes

    FDA approved the MiniMed 670G hybrid closed loop system from Medtronic plc (NYSE:MDT) to adjust insulin levels in Type I diabetics aged 14 and older with minimal input from the patient. The system includes a sensor that…

    Published on 9/28/2016
  • COMPANY NEWS: Santhera starts Phase III DMD trial

    Santhera Pharmaceuticals Holding AG (SIX:SANN) said it enrolled the first patient in its Phase III SIDEROS study of Raxone idebenone to treat Duchenne muscular dystrophy. The company hopes to include SIDEROS data, which…

    Published on 9/28/2016
  • COMPANY NEWS: Management tracks

    Antibody company Prothena Corp. plc (NASDAQ:PRTA) said President and CEO Dale Schenk is taking a medical leave of absence. He will remain on Prothena's board. COO Gene Kinney will lead the company in Schenk's absence.…

    Published on 9/27/2016
  • COMPANY NEWS: Shire returns rights to Momenta, Coherus biosimilars

    Shire plc (LSE:SHP; NASDAQ:SHPG) ended deals with Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) and Coherus BioSciences Inc. (NASDAQ:CHRS) and returned rights to biosimilar candidates. Shire had gained rights to both …

    Published on 9/27/2016
  • COMPANY NEWS: Biogen submits nusinersen NDA

    Biogen Inc. (NASDAQ:BIIB) completed submission of a rolling NDA to FDA for nusinersen (IONIS-SMNRx) to treat spinal muscular atrophy (SMA). The company requested Priority Review for nusinersen, an antisense …

    Published on 9/26/2016
  • COMPANY NEWS: Dupilumab under FDA review for atopic dermatitis

    Sanofi (Euronext:SAN; NYSE:SNY) and partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA accepted and granted Priority Review to a BLA for dupilumab (REGN668) to treat adults with inadequately controlled …

    Published on 9/26/2016
  • COMPANY NEWS: FDA again delays Remoxy's approval

    FDA issued a complete response letter for Remoxy oxycodone from Pain Therapeutics Inc. (NASDAQ:PTIE), which was under review to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment …

    Published on 9/26/2016
  • COMPANY NEWS: FDA reviewing romosozumab BLA

    Amgen Inc. (NASDAQ:AMGN) and partner UCB Group (Euronext:UCB) said FDA accepted a BLA for romosozumab (AMG 785) to treat osteoporosis in postmenopausal women at increased risk of fracture. Its PDUFA date is July 19, …

    Published on 9/26/2016
  • 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

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