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  • TOP STORY: Democrats snub 21st Century Cures bill

    Nine months after U.S. House Energy & Commerce Committee chairman Rep. Fred Upton (R-Mich.) launched the 21st Century Cures initiative as a bipartisan effort, the committee released a discussion draft Tuesday without …

    Published on 1/27/2015
  • TOP STORY: FDA names Duke's Califf as deputy commissioner

    FDA named Robert Califf as deputy commissioner for medical products and tobacco, positioning the Duke University physician as a likely successor to Commissioner Margaret Hamburg if she steps down before the end of the …

    Published on 1/26/2015
  • TOP STORY: FDA approves NPS's Natpara with boxed warning

    FDA approved Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The recombinant human parathyroid hormone 1-84 (PTH) …

    Published on 1/23/2015
  • TOP STORY: Warren's punishing scheme to tap pharma for NIH

    Sen. Elizabeth Warren (D-Mass.) plans to introduce legislation next week that she said would force large pharmaceutical companies entering major settlements with the U.S. government to pay NIH "one percent of an …

    Published on 1/22/2015
  • TOP STORY: China's Innovent raises $100M in series C

    Innovent Biologics Inc. (Suzhou, China) raised $100 million in an untranched series C round led by new investor Legend Capital. Singapore's Temasek and two other undisclosed new investors also participated, along with …

    Published on 1/21/2015
  • TOP STORY: Volatility continues to dog CAR T stocks

    After a partial recovery last Friday, shares of companies developing chimeric antigen receptor (CAR) T cell therapies fell on Tuesday after an article in the New York Times suggested the sector may be overheated. The …

    Published on 1/20/2015
  • TOP STORY: Roche buys neuromuscular play Trophos

    Roche (SIX:ROG; OTCQX:RHHBY) acquired neuromuscular disease play Trophos S.A. (Marseille, France) for EUR 120 million ($141.8 million) in upfront cash. Trophos shareholders are eligible for up to EUR 350 million ($413.6…

    Published on 1/16/2015
  • TOP STORY: Two more payers pick Harvoni

    Humana Inc. (NYSE:HUM) and Harvard Pilgrim Health Care Inc. each said they selected Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) as the exclusive option for HCV genotype 1 patients and thus will…

    Published on 1/15/2015
  • TOP STORY: Intrexon, Ziopharm rise after Sleeping Beauty deal

    Ziopharm Oncology Inc. (NASDAQ:ZIOP) and Intrexon Corp. (NYSE:XON) licensed chimeric antigen receptor (CAR) T cell technology from the University of Texas MD Anderson Cancer Center (Houston, Texas) that the companies …

    Published on 1/14/2015
  • TOP STORY: Pharmacyclics expects Imbruvica sales to double

    Pharmacyclics Inc. (NASDAQ:PCYC) rose $20.29 (16%) to $144 on Tuesday, gaining $1.5 billion in market cap to $10.9 billion after it said U.S. sales of oncology drug Imbruvica ibrutinib beat analyst estimates in 4Q14 and…

    Published on 1/13/2015
  • TOP STORY: NPS acquisition could push Shire past 2020 goal

    Shire plc (LSE:SHP; NASDAQ:SHPG) will acquire rare disease play NPS Pharmaceuticals Inc. (NASDAQ:NPSP) for $46 per share, or $5.2 billion in cash. The price represents a 51% premium to NPS's close of $30.47 on Dec. 16, …

    Published on 1/12/2015
  • TOP STORY: FDA gets earful on LDTs

    An overwhelming majority of attendees at a two-day workshop to discuss FDA's draft guidance on laboratory-developed diagnostic tests (LDTs) were opposed to the guidance, which seeks to outline a new regulatory path for …

    Published on 1/9/2015
  • TOP STORY: Anthem picks Harvoni

    Anthem Inc. (NYSE:ANTM) said Thursday it would make Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) its preferred drug to treat HCV across its employer-based plans.The payer said Harvoni would have…

    Published on 1/8/2015
  • TOP STORY: FDA panel unanimously backs biosimilar Zarxio

    FDA's Oncologic Drugs Advisory Committee voted 14-0 to recommend approval of Zarxio (EP2006) G-CSF from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), a biosimilar of neutropenia drug Neupogen filgrastim from …

    Published on 1/7/2015
  • TOP STORY: FDA integrating patient preference into device decisions

    FDA has taken a step toward moving patient-centered drug regulation from anecdotal reports collected at open public meetings to a quantitative approach based on data obtained in controlled experiments. In an article …

    Published on 1/6/2015
  • TOP STORY: Crossover investors join Moderna's $450M round

    Moderna Therapeutics Inc. (Cambridge, Mass.) raised $450 million in the largest biotech venture financing on record. New investors included Viking Global Investors; Invus; RA Capital Management; and Wellington …

    Published on 1/5/2015
  • TOP STORY: Taiwan, China embark on cross-strait clinical studies

    Companies like Taiwan Liposome Co. Ltd. (GreTai:4152) will gain access to a larger patient pool in mainland China thanks to an evolving agreement between Beijing and Taipei to share clinical data in selected hospitals. …

    Published on 12/31/2014
  • TOP STORY: NeuroDerm nearly triples on Phase II PD data

    NeuroDerm Ltd. (NASDAQ:NDRM) surged $11.96 (194%) to $18.14 on Tuesday after reporting data from a Phase IIa study of ND0612H and ND0612L, two doses of its subcutaneous levodopa/carbidopa therapy for Parkinson's disease…

    Published on 12/30/2014
  • TOP STORY: Biotech stocks recovering from Bloody Tuesday

    The BioCentury 100 and the NYSE Arca Biotechnology (BTK) indexes both edged up for a third day on Monday after dropping last week in the fallout from news that Express Scripts Holding Co. (NASDAQ:ESRX) had fired the …

    Published on 12/29/2014
  • TOP STORY: Bloody Tuesday for biotech

    Biotech shares dropped in the wake of Monday's news of price wars for HCV drugs, with the BioCentury 100 index falling 5% and the NYSE Arca Biotechnology (BTK) dropping 4%.The BioCentury benchmark has fallen 6% since …

    Published on 12/23/2014
  • TOP STORY: AbbVie fires first in HCV price war

    Pharmacy benefit manager Express Scripts Holding Co. Inc. (NASDAQ:ESRX) worked overtime to make good on its pledge to hammer expensive drugs for HCV, granting exclusive formulary status to Viekira Pak from AbbVie Inc. (…

    Published on 12/22/2014
  • TOP STORY: FDA approves AbbVie's HCV regimen

    FDA approved Viekira Pak from AbbVie Inc. (NYSE:ABBV) with or without ribavirin to treat HCV genotype 1 infection in patients with and without compensated cirrhosis. AbbVie set the WAC for the three direct-acting-…

    Published on 12/19/2014
  • TOP STORY: Juno prices IPO; Bellicum soars

    Cancer immunotherapy plays Juno Therapeutics Inc. (NASDAQ:JUNO) and Bellicum Pharmaceuticals Inc. (NASDAQ:BCLM) priced their upsized IPOs, with Bellicum gaining in first-day trading Thursday.Juno priced above its …

    Published on 12/18/2014
  • TOP STORY: Amgen prices Blincyto

    Amgen Inc. (NASDAQ:AMGN) said it will launch leukemia drug Blincyto blinatumomab on Thursday with a price of $3,178.57 per single-use vial, or $89,000 for a 28-day treatment cycle.Amgen spokesperson Lori Melancon said …

    Published on 12/17/2014
  • TOP STORY: Auspex jumps on Phase III Huntington's data

    Auspex Pharmaceuticals Inc. (NASDAQ:ASPX) surged $15.91 (63%) to $41.00 in after-hours trading after topline data late Tuesday showed its SD-809 met the primary endpoint of improving chorea (sudden, rapid uncontrolled …

    Published on 12/16/2014

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