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  • TOP STORY: Intarcia licenses ITCA 650 to Servier ex-U.S., Japan

    Intarcia Therapeutics Inc. (Boston, Mass.) has granted Servier (Neuilly-sur-Seine, France) exclusive development and commercialization rights to implantable diabetes therapy ITCA 650 outside the U.S. and Japan.Intarcia …

    Published on 11/12/2014
  • TOP STORY: Brodalumab tops Stelara in Phase III psoriasis trial

    Amgen Inc. (NASDAQ:AMGN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said brodalumab showed superiority to Stelara ustekinumab from Johnson & Johnson (NYSE:JNJ) and placebo in the head-to-head Phase III AMAGINE-3 trial to …

    Published on 11/11/2014
  • TOP STORY: China launches its biosimilars process

    The China Food and Drug Administration has issued draft guidance that lays down principles for developing biosimilars of biologics already approved in China, including products intended to be extrapolated to multiple …

    Published on 11/10/2014
  • TOP STORY: FLINTy reception for Intercept

    Although a Bloomberg report on The Lancet's publication of data from the Phase II FLINT trial of obeticholic acid in non-alcoholic steatohepatitis (NASH) largely rehashed old ground, investors hammered shares of …

    Published on 11/7/2014
  • TOP STORY: Salix hit on accounting turmoil

    Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) plunged $53.05 (38%) to $85.50 in after-hours trading on Thursday on news its CFO had resigned and the company had retained outside counsel to investigate how it was accounting …

    Published on 11/6/2014
  • TOP STORY: MMRF, FDA, NCI to develop multiple myeloma master protocol

    The Multiple Myeloma Research Foundation (MMRF) announced plans to develop a multiple myeloma (MM) "master protocol" in partnership with FDA, the National Cancer Institute (NCI), industry and academic leaders, and …

    Published on 11/5/2014
  • TOP STORY: Eylea numbers surprise Street

    Shares of Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) fell $22.87 to $372.39 on Tuesday after it lowered the top end of its guidance for U.S. sales of Eylea aflibercept in 2014 and cautioned that the sales ramp in the …

    Published on 11/4/2014
  • TOP STORY: Amgen opens new front in biosimilar dispute with Sandoz

    Amgen Inc. (NASDAQ:AMGN) added fuel on top of its lawsuit against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) with a Citizen's Petition asking FDA to require that biosimilar applications include a certification …

    Published on 11/3/2014
  • TOP STORY: Sarepta silent on FDA's riposte

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) declined to comment on Friday after FDA vigorously defended itself in front of the Duchenne muscular dystrophy (DMD) community over the agency's advice and treatment of the …

    Published on 10/31/2014
  • TOP STORY: Amgen sues Sandoz over filgrastim biosimilar BLA

    In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent …

    Published on 10/30/2014
  • TOP STORY: Sanofi ouster opens can of worms

    Sanofi (Euronext:SAN; NYSE:SNY) shares touched a 52-week low of $44.50 in New York on Wednesday before its ADSs closed down $2.85 (6%) to $45.22, on the news that Christopher Viehbacher had been removed as CEO, a move …

    Published on 10/29/2014
  • TOP STORY: Sovaldi sales drop on Harvoni launch

    Executives at Gilead Sciences Inc. (NASDAQ:GILD) on Tuesday were circumspect about forecasting the sales ramp for the company's HCV franchise comprising ultrablockbuster Sovaldi sofosbuvir and its newly lauched Harvoni …

    Published on 10/28/2014
  • TOP STORY: Receptos doubles up with RPC1063 in UC

    Receptos Inc. (NASDAQ:RCPT) on Monday reported that RPC1063 met the primary endpoint in a Phase II trial in a second hot disease space, ulcerative colitis (UC), and now needs to think strategically about its partnering …

    Published on 10/27/2014
  • TOP STORY: Shire sets its peer group

    With a $1.6 billion breakup fee in hand from erstwhile merger partner AbbVie Inc. (NYSE:ABBV), Shire plc (LSE:SHP; NASDAQ:SHPG) on Friday reiterated its prospects as an independent company focused on rare and specialty …

    Published on 10/24/2014
  • TOP STORY: Celgene boosts itself, Acceleron

    Celgene Corp. (NASDAQ:CELG) added $5.64 (5.9%) to $100.40 on Thursday after reporting adjusted net income of $806 million in 3Q14, up 20% from $669 million in 3Q13, and upped its revenue and EPS guidance for the year.In…

    Published on 10/23/2014
  • TOP STORY: GSK shuffles top management

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reshuffled its executive management as it prepares to integrate the vaccines business it is acquiring from Novartis AG (NYSE:NVS; SIX:NOVN) in an asset-swapping deal announced in …

    Published on 10/22/2014
  • TOP STORY: Third Point pushes for Amgen breakup

    Activist investor Third Point on Tuesday outlined a plan for increasing the valuation of Amgen Inc. (NASDAQ:AMGN) by more than 80% in the next two years. The firm wants Amgen to split into two companies, one each for "…

    Published on 10/21/2014
  • TOP STORY: NewLink lands $150M upfront from Genentech

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) acquired exclusive, worldwide rights to cancer candidate NLG919 from NewLink Genetics Corp. (NASDAQ:NLNK) for $150 million up front. NewLink is eligible for …

    Published on 10/20/2014
  • TOP STORY: Amgen sues Sanofi, Regeneron over PCSK9

    Amgen Inc. (NASDAQ:AMGN) filed a lawsuit in the U.S. District Court for the District of Delaware alleging that alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) infringes…

    Published on 10/17/2014
  • TOP STORY: Canaan closes tenth fund at $675M

    Canaan Partners closed its tenth fund, Canaan X, with $675 million. The firm expects to invest about a third of the fund, or $225 million, in healthcare, with the rest earmarked for IT. Within healthcare, the firm plans…

    Published on 10/16/2014
  • TOP STORY: FDA accelerates approval for Esbriet, Ofev

    FDA on Wednesday approved two drugs for idiopathic pulmonary fibrosis (IPF): Esbriet pirfenidone from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Ofev nintedanib from Boehringer Ingelheim GmbH (…

    Published on 10/15/2014
  • TOP STORY: J&J vows "competitive" HCV pricing

    Johnson & Johnson CFO Dominic Caruso said the company intends to "remain competitive in the HCV category" following the approval of Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), suggesting the…

    Published on 10/14/2014
  • TOP STORY: Alnylam up on patisiran Phase II extension data

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) jumped $13.83 (19%) to $86.68 after six-month data from a Phase II study of patisiran ( ALN-TTR02) suggested the compound may have halted progression of transthyretin (TTR)-…

    Published on 10/13/2014
  • TOP STORY: FDA approves Gilead's Harvoni HCV combo

    FDA approved Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), the first oral combination therapy to treat chronic HCV genotype 1 infection that does not require interferon or ribavirin. Harvoni is …

    Published on 10/10/2014
  • TOP STORY: Achillion HCV combo has 100% SVR in Phase II

    A combination including ACH-3102 from Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) led to 100% SVR8 rates in a Phase II study to treat HCV genotype 1, according to an abstract released ahead of the American Association …

    Published on 10/9/2014

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