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  • TOP STORY: ASCO publishes its value framework

    The American Society of Clinical Oncology published in the Journal of Clinical Oncology a framework designed to assess the value of cancer drugs. ASCO also published an assessment of drugs to treat four different tumor …

    Published on 6/22/2015
  • TOP STORY: PTAB to consider sanctions against Bass

    The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has accepted a request from Celgene Corp. (NASDAQ:CELG) to consider sanctions against the Coalition for Affordable Drugs, an entity controlled by…

    Published on 6/19/2015
  • TOP STORY: Generic Copaxone launched after CAFC invalidates Teva patent

    The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) launched once-daily multiple sclerosis (MS) drug Glatopa glatiramer acetate in the U.S. after the U.S. Court of Appeals for the Federal Circuit (CAFC) invalidated the …

    Published on 6/18/2015
  • TOP STORY: BioMarin gains on Phase II achondroplasia data

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) gained $7.95 to $131.55 in after-hours trading Wednesday after reporting results from a Phase II trial of vosoritide (BMN 111) in 26 children aged 5-14 with achondroplasia, a …

    Published on 6/17/2015
  • TOP STORY: Clintons focusing on drug prices

    Former President Bill Clinton urged biotech executives to do a better job explaining drug pricing and value during a speech and question-and-answer session held Monday in conjunction with the Biotechnology Industry …

    Published on 6/16/2015
  • TOP STORY: Avalanche tumbles on AMD data

    Avalanche Biotechnologies Inc. (NASDAQ:AAVL) fell $15.99 (41%) to $22.89 in after-hours trading Monday after it released top-line data from a Phase IIa study of its AVA-101 gene therapy to treat wet age-related macular …

    Published on 6/15/2015
  • TOP STORY: Agios slips on updated Phase I hematology data

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO) shed $12.46 (10%) to $110.13 on Friday after updated Phase I data for AG-221 and AG-120 showed lower response rates in patients with advanced hematological malignancies than …

    Published on 6/12/2015
  • TOP STORY: Axovant shares nearly double after upsized $315M IPO

    Axovant Sciences Ltd. (NYSE:AXON) gained $14.90 (99%) to $29.90 in its first day of trading Thursday, giving it a market cap of $2.9 billion, after it raised $315 million in an IPO through the sale of 21 million shares …

    Published on 6/11/2015
  • TOP STORY: FDA panel backs Repatha

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 15-0 to support approval of Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) to treat homozygous familial hypercholesterolemia (HoFH). The panel also …

    Published on 6/10/2015
  • TOP STORY: FDA panel backs Praluent in restricted populations

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-3 to support approval of Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat …

    Published on 6/9/2015
  • TOP STORY: Repatha panelists to discuss LDL surrogate, dose strength

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee will discuss LDL-C lowering as a surrogate for cardiovascular benefit as it evaluates a BLA for PCSK9 inhibitor Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN…

    Published on 6/8/2015
  • TOP STORY: Praluent panelists to consider LDL as surrogate for CV benefit

    FDA will ask its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss whether LDL-C lowering is a surrogate for cardiovascular benefit of first-in-class PCSK9 inhibitor Praluent alirocumab from …

    Published on 6/5/2015
  • TOP STORY: Senate IPR reform a work in progress

    The U.S. Senate Judiciary Committee endorsed the Patent Act (S. 1137) Thursday by a 16-4 vote, although the bill's sponsors said they intend to modify it to address concerns from the life sciences industry prior to a …

    Published on 6/4/2015
  • TOP STORY: bluebird, Celgene narrow CAR-T partnership

    bluebird bio Inc. (NASDAQ:BLUE) and Celgene Corp. (NASDAQ:CELG) narrowed their 2013 multi-target partnership to develop chimeric antigen receptor (CAR) T cell therapies to focus on a single target: tumor necrosis factor…

    Published on 6/3/2015
  • TOP STORY: Juno acquires antibody company X-Body

    Juno Therapeutics Inc. (NASDAQ:JUNO) acquired X-Body Inc. (Waltham, Mass.), giving Juno an antibody discovery platform that will allow it to produce new chimeric antigen receptor (CAR) T cell and T cell receptor (TCR) …

    Published on 6/2/2015
  • 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

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