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  • TOP STORY: FDA funding added to 21st Century Cures Act

    The U.S. House Energy & Commerce Committee passed the 21st Century Cures Act (H.R. 6) on Thursday by a 51-0 vote following the last minute addition of FDA funding provisions. The bill includes a "Cures Innovation Fund" …

    Published on 5/21/2015
  • TOP STORY: J&J outlines goals through 2019

    Johnson & Johnson (NYSE:JNJ) plans to submit 15 regulatory applications for NMEs by the end of this decade, including more than 10 for candidates with the potential to exceed $1 billion in revenue. The company also …

    Published on 5/20/2015
  • TOP STORY: Achillion, Janssen partner to develop HCV combo

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) granted the Janssen Pharmaceuticals Inc. subsidiary of Johnson & Johnson (NYSE:JNJ) exclusive, worldwide rights to develop and commercialize treatment regimens containing …

    Published on 5/19/2015
  • TOP STORY: Eleven plummets after Phase III dry eye miss

    Eleven Biotherapeutics Inc. (NASDAQ:EBIO) sank $8.28 (69%) to $3.69 on Monday after lead candidate EBI-005 missed the co-primary endpoints in the Phase III OASIS trial to treat moderate-to-severe dry eye disease. In …

    Published on 5/18/2015
  • TOP STORY: Alder, Amgen up after migraine data

    Shares of Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) and Amgen Inc. (NASDAQ:AMGN) rose after the companies reported data for migraine therapies targeting calcitonin gene-related peptide (CGRP) at the Congress of the …

    Published on 5/15/2015
  • TOP STORY: Multiple myeloma data on parade at ASCO

    A series of abstracts released ahead of the American Society of Clinical Oncology (ASCO) meeting revealed efficacy data from studies of multiple myeloma compounds elotuzumab from AbbVie Inc. (NYSE:ABBV) and Bristol-…

    Published on 5/14/2015
  • TOP STORY: New 21st Century Cures draft adds Orphan incentive

    The U.S. House Energy & Commerce Committee on Wednesday released a new draft of its 21st Century Cures Act that included most of the provisions from the draft released in April and added a new incentive for sponsors to …

    Published on 5/13/2015
  • TOP STORY: Orexigen falls after LIGHT update and trial termination

    Orexigen Therapeutics Inc. (NASDAQ:OREX) shed $0.93 (14%) to $5.93 after an updated interim analysis of the LIGHT cardiovascular outcomes trial of Contrave naltrexone/buproprion showed that the obesity drug may not have…

    Published on 5/12/2015
  • TOP STORY: Investors not IMPRESSed as NewLink trial continues

    NewLink Genetics Corp. (NASDAQ:NLNK) lost $9.74 (19%) to $42.40 in after-hours trading on Monday after it said it would continue the Phase III IMPRESS trial of HyperAcute Pancreas algenpantucel-L to treat resected …

    Published on 5/11/2015
  • TOP STORY: Industry balks at paying for 21st Century Cures

    U.S. House Energy & Commerce Committee staff have asked the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) to offset some or all of the cost of the …

    Published on 5/8/2015
  • TOP STORY: G-BA postpones Glybera assessment

    Germany's Federal Joint Committee (G-BA) postponed until May 21 its expected decision on a benefit assessment of gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE). The committee did not provide a…

    Published on 5/7/2015
  • TOP STORY: Alexion to acquire Synageva

    Synageva BioPharma Corp. (NASDAQ:GEVA) soared $107.52 (112%) to $203.39 on news that Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) will acquire the company for $115 in cash and 0.6581 Alexion shares per Synageva share, or …

    Published on 5/6/2015
  • TOP STORY: MorphoSys reports 1Q15 earnings

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) reported 1Q15 revenues of EUR 70.4 million ($78.5 million), up from 1Q14 revenues of EUR 15.9 million ($17.7 million). The gains were largely due to the receipt of deferred revenues …

    Published on 5/5/2015
  • TOP STORY: Spark falls on UPenn's transient results in LCA

    Spark Therapeutics Inc. (NASDAQ:ONCE) slipped $3.51 to $55.01 on Monday after two studies in the New England Journal of Medicine showed that treatment effects of gene therapies declined over time in patients with Leber …

    Published on 5/4/2015
  • TOP STORY: Gilead climbs on 1Q15 earnings

    Gilead Sciences Inc. (NASDAQ:GILD) gained $4.52 to $105.03 on Friday, adding $6.7 billion in market cap to $156 billion as investors reacted to the company's 1Q15 earnings, released after market close on Thursday.The …

    Published on 5/1/2015
  • TOP STORY: House holds 21st Century Cures hearing

    U.S. House Energy & Commerce Committee members expressed bipartisan support for the second discussion draft of 21st Century Cures legislation at a hearing Thursday. Committee members outlined topics they intend to add …

    Published on 4/30/2015
  • TOP STORY: Second draft of 21st Century Cures released

    The U.S. House Energy & Commerce Committee released on Wednesday a slimmed-down discussion draft of its 21st Century Cures legislation with support from Republicans and Democrats, including Reps. Frank Pallone (D-N.J.) …

    Published on 4/29/2015
  • TOP STORY: FDA's biosimilars guidances leave questions begging

    FDA released three final guidance documents on biosimilars on Monday, but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for…

    Published on 4/28/2015
  • TOP STORY: Celladon gene therapy fails in heart failure study

    One of the quarter's most eagerly anticipated data events came up short, as Celladon Corp. (NASDAQ:CLDN) plummeted $11.04 (81%) to $2.64 on Monday after its Mydicar gene therapy missed the primary and secondary …

    Published on 4/27/2015
  • TOP STORY: Biogen falls on Tecfidera miss

    Biogen Inc. (NASDAQ:BIIB) shed $28.57 to $401.71 on Friday, losing $6.7 billion of market cap, as investors digested disappointing sales of Tecfidera dimethyl fumarate. The multiple sclerosis (MS) drug posted 1Q15 …

    Published on 4/24/2015
  • TOP STORY: Germinating arguments on CRISPR

    Meeting both expectations and concerns in the scientific community that the gene-editing technique CRISPR/Cas9 (CRISPR-associated protein 9) would be applied to human embryos, a group of Chinese researchers has …

    Published on 4/23/2015
  • TOP STORY: Ultragenyx gains on De Vivo results

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) gained $2.74 Wednesday to $66.96 after announcing positive results from an investigator-sponsored Phase II study in six evaluable patients with glucose transporter type-1 …

    Published on 4/22/2015
  • TOP STORY: Amgen boosts revenue guidance ahead of Repatha

    Amgen Inc. (NASDAQ:AMGN) boosted its revenue guidance for 2015 as it prepares to launch products in its new cardiovascular business and anticipates regulatory actions in its cancer franchise. EVP of R&D Sean Harper said…

    Published on 4/21/2015
  • TOP STORY: CAR T stocks fall on solid tumor data

    CAR T data from Novartis AG (NYSE:NVS; SIX:NOVN) and the University of Pennsylvania demonstrated much of what's already known about the challenges of moving the technology into the solid tumor setting. A presentation at…

    Published on 4/20/2015
  • TOP STORY: G-BA suspends Glybera assessment pending EMA decision

    The German reimbursement agency G-BA suspended its benefit assessment of gene therapy Glybera alipogene tiparvovec from uniQure N.V. (NASDAQ:QURE). The move followed uniQure's disclosure in an SEC filing that on April 8…

    Published on 4/17/2015

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