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Chronological Index of : Top Story

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  • TOP STORY: CHMP backs Zydelig, Imbruvica

    EMA's CHMP issued positive opinions for several drugs on Friday, including Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) and Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & …

    Published on 7/25/2014
  • TOP STORY: FDA accepts Sandoz's BLA for filgrastim biosimilar

    Sandoz, a unit of Novartis AG (NYSE:NVS; SIX:NOVN), said FDA accepted a BLA for a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). Sandoz is the first company to announce FDA's acceptance …

    Published on 7/24/2014
  • TOP STORY: Sovaldi sales hit $3.5 billion in 2Q14

    Gilead Sciences Inc. (NASDAQ:GILD) reported 2Q14 financial results that beat the Street, including $3.5 billion in sales of HCV drug Sovaldi sofosbuvir. The Street was expecting $2.5-$2.6 billion in Sovaldi sales in the…

    Published on 7/23/2014
  • TOP STORY: Appeals courts issue conflicting ACA rulings

    Two appeals courts issued conflicting rulings on whether enrollees on the Affordable Care Act's federal health exchanges are eligible for subsidies -- an issue central to the law's implementation. On Tuesday, the U.S. …

    Published on 7/22/2014
  • TOP STORY: Cerecor raises $15 million in B round

    Cerecor Inc. (Baltimore, Md.) raised $15 million in the first tranche of a planned $32 million series B round. New investors New Enterprise Associates; Apple Tree Partners; and MPM Capital led the tranche. Cerecor's …

    Published on 7/21/2014
  • TOP STORY: AbbVie to acquire Shire

    AbbVie Inc. (NYSE:ABBV) will acquire Shire plc (LSE:SHP; NASDAQ:SHPG) for about L31.4 billion ($53.8 billion) in cash and stock. The offer comprises L24.44 in cash and 0.8960 AbbVie shares per Shire share. Shire …

    Published on 7/18/2014
  • TOP STORY: GSK stops melanoma trial early on interim data

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said an interim analysis by an independent DMC showed Tafinlar dabrafenib plus Mekinist trametinib met a prespecified threshold of improving overall survival (OS), the primary …

    Published on 7/17/2014
  • TOP STORY: Crenezumab misses in AD Phase IIs

    Crenezumab from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) missed the primary and secondary endpoints in two Phase II trials to treat Alzheimer's disease. Genentech said it is "premature" to discuss development …

    Published on 7/16/2014
  • TOP STORY: Yellen says biotech valuations 'substantially stretched'

    Healthcare indices posted sharper declines than the broader markets Tuesday after Federal Reserve Chairperson Janet Yellen said valuations for smaller biotech firms "appear substantially stretched" despite a correction …

    Published on 7/15/2014
  • TOP STORY: Shire 'willing to recommend' upped AbbVie bid

    Shire plc (LSE:SHP; NASDAQ:SHPG) said its board would be "willing to recommend" an increased bid from AbbVie Inc. (NYSE:ABBV) to acquire the company. The new bid values Shire at L31.8 billion ($54.5 billion) in cash and…

    Published on 7/14/2014
  • TOP STORY: Senators push for details on Sovaldi's cost

    Two members of the Senate Finance Committee requested pricing information for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), including an explanation of the difference between the drug's current …

    Published on 7/11/2014
  • TOP STORY: Sarepta falls on additional DMD data

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) fell $3.35 (13%) to $22.54 on Thursday after reporting data some analysts said raise questions about the long-term efficacy of eteplirsen (AVI-4658) for Duchenne muscular …

    Published on 7/10/2014
  • TOP STORY: EMA delays transparency policy

    EMA's management board postponed the adoption of its clinical data transparency policy to its Oct. 2 meeting, rather than the previously expected mid-July time frame. The agency said it wants to discuss wording …

    Published on 7/9/2014
  • TOP STORY: AbbVie ups Shire bid

    AbbVie Inc. (NYSE:ABBV) increased by about 11% its bid to acquire Shire plc (LSE:SHP; NASDAQ:SHPG). The new bid values Shire at roughly L30.6 billion ($52.5 billion) in cash and stock. Last month, Shire rejected an …

    Published on 7/8/2014
  • TOP STORY: Japan approves drugs for cancer, HCV, TB

    Japan's Ministry of Health, Labor and Welfare (MHLW) approved several new drugs on Friday, including Opdivo nivolumab from Ono Pharmaceutical Co. Ltd. (Tokyo:4528) to treat unresectable melanoma. The approval requires …

    Published on 7/7/2014
  • TOP STORY: Regado slips on Revolixys trial halt

    Regado Biosciences Inc. (NASDAQ:RGDO) fell $3.92 (58%) to $2.84 on Thursday after announcing late Wednesday that it halted enrollment in the Phase III REGULATE-PCI trial with its Revolixys Kit (formerly REG1) to treat …

    Published on 7/3/2014
  • TOP STORY: Genentech to acquire Seragon

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) will acquire cancer company Seragon Pharmaceuticals Inc. (San Diego, Calif.) for $725 million in cash up front plus up to $1 billion in milestones. Seragon is …

    Published on 7/2/2014
  • TOP STORY: Transcept, Paratek to merge, raise $93 million

    Transcept Pharmaceuticals Inc. (NASDAQ:TSPT) will merge with infectious disease company Paratek Pharmaceuticals Inc. (Boston, Mass.) in a stock deal. Transcept will issue Paratek stockholders about 167.5 million …

    Published on 7/1/2014
  • TOP STORY: Allergan's wet AMD product to move to Phase III

    Allergan Inc. (NYSE:AGN) reported top-line data from its double-blind Stage 3, Phase II study of 64 treatment-naïve patients with wet age-related macular degeneration (AMD) that showed intravitreal abicipar pegol (…

    Published on 6/30/2014
  • TOP STORY: CHMP backs Bristol-Myers' daclatasvir

    EMA's CHMP backed the use of HCV candidate Daklinza daclatasvir (BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY), which also disclosed on Friday that FDA accepted for Priority Review an NDA for the selective HCV …

    Published on 6/27/2014
  • TOP STORY: Auxilium to merge with QLT

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) will merge with ophthalmic play QLT Inc. (TSX:QLT; NASDAQ:QLTI) in a stock deal. The combined company will be incorporated in Canada, led by Auxilium's management and will be …

    Published on 6/26/2014
  • TOP STORY: FDA panel rebuffs olaparib

    FDA's Oncologic Drugs Advisory Committee voted 11-2 that safety and efficacy data do not support accelerated approval of olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and that the agency should delay considering …

    Published on 6/25/2014
  • TOP STORY: Vertex jumps on CF data

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) jumped $26.92 (40%) to $93.53 on Tuesday on positive data for two of the company's CF agents in a pair of Phase III trials -- a data readout that investors told BioCentury would…

    Published on 6/24/2014
  • TOP STORY: Roche, Versant, Inception launch remyelination newco

    Roche (SIX:ROG; OTCQX:RHHBY) partnered with Versant Ventures and drug discovery company Inception Sciences Inc. (San Diego, Calif.) to launch newco Inception 5 to screen and develop small molecules for myelin repair in …

    Published on 6/23/2014
  • TOP STORY: Shire rejects AbbVie bids

    Shire plc (LSE:SHP; NASDAQ:SHPG) gained $31.18 (16%) to $222.89 on NASDAQ and was up 633p (17%) to 4,371p in London on Friday after disclosing its board rejected an unsolicited offer from AbbVie Inc. (NYSE:ABBV) to …

    Published on 6/20/2014

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