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  • TOP STORY: ASCO focuses on value and cost

    Value and costs of cancer care were dominant themes over the weekend at the American Society of Clinical Oncology meeting in Chicago, with five separate sessions on the topics, including alternative payment models to …

    Published on 6/1/2015
  • TOP STORY: Opdivo NSCLC, HCC data showcased at ASCO

    Bristol-Myers Squibb Co. (NYSE:BMY) shed $4.55 to $64.60 on Friday after data presented at the American Society of Clinical Oncology (ASCO) meeting detailed the survival benefit from Opdivo nivolumab in patients with …

    Published on 5/29/2015
  • TOP STORY: Merck, NanoString seek Keytruda biomarkers

    Merck and Co. Inc. (NYSE:MRK) and NanoString Technologies Inc. (NASDAQ:NSTG) will collaborate to develop a biomarker assay that may predict patient responses to melanoma drug Keytruda pembrolizumab. NanoString CEO Brad …

    Published on 5/28/2015
  • TOP STORY: Express Scripts mulls indication-based pricing in cancer

    Express Scripts Holding Co. (NASDAQ:ESRX) is in discussions with manufacturers about indication-based pricing for cancer drugs. Under the model, a drug approved for different indications could have different prices …

    Published on 5/27/2015
  • TOP STORY: White House calls for limitations on human gene editing

    The White House Office of Science and Technology Policy (OSTP) said Tuesday that "altering the human germline for clinical purposes is a line that should not be crossed at this time" in a statement outlining the …

    Published on 5/26/2015
  • TOP STORY: Amgen exits brodalumab collaboration with AZ

    Amgen Inc. (NASDAQ:AMGN) said it is withdrawing from a collaboration with AstraZeneca plc (LSE:AZN; NYSE:AZN) to develop and commercialize brodalumab because Amgen is concerned the compound will require restrictive …

    Published on 5/22/2015
  • 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

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