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  • TOP STORY: uniQure partner prices gene therapy Glybera at EUR 1.1M

    Chiesi Farmaceutici S.p.A (Parma, Italy) has filed a pricing dossier for Glybera alipogene tiparvovec with Germany's Federal Joint Committee (G-BA) that pegs the price of the gene therapy at over EUR 1 million. Chiesi …

    Published on 11/26/2014
  • TOP STORY: Cell Medica raises L50M series B

    Cell therapy developer Cell Medica Ltd. (London, U.K.) raised L50 million ($78.2 million) in a series B round led by Imperial Innovations. Invesco Perpetual and Woodford Investment Management also participated.Cell …

    Published on 11/25/2014
  • TOP STORY: BioMarin to acquire Prosensa

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) has concluded it can successfully make the case to gain approval for drisapersen to treat Duchenne muscular dystrophy after it acquires Prosensa Holding N.V. (NASDAQ:RNA) for $…

    Published on 11/24/2014
  • TOP STORY: Rep. Upton updates 21st Century Cures timeline

    Rep. Fred Upton (R-Mich.) said he plans to release a discussion draft in mid-January 2015 of legislation based on the 21st Century Cures initiative he and Rep. Diana DeGette (D-Colo.) launched in May.Speaking at a …

    Published on 11/21/2014
  • TOP STORY: Clovis reports interim Phase II in PARP race

    Clovis Oncology Inc. (NASDAQ:CLVS) reported initial data from the Phase II ARIEL2 trial of rucaparib (CO-338) to treat platinum-sensitive, relapsed ovarian cancer. The biotech suggested combining tumor BRCA1/2 mutation …

    Published on 11/20/2014
  • TOP STORY: CF Foundation sells royalty rights for $3.3B

    Royalty Pharma (New York, N.Y.) paid $3.3 billion to acquire the Cystic Fibrosis Foundation's rights to royalties from cystic fibrosis (CF) treatments developed by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). The deal …

    Published on 11/19/2014
  • TOP STORY: CRISPR newco Intellia gets $15M from Atlas, Novartis

    Intellia Therapeutics Inc. (Cambridge, Mass.) closed a $15 million series A round from Atlas Venture and Novartis AG (NYSE:NVS; SIX:NOVN) to develop therapeutics using CRISPR-Cas9 technology.Intellia is developing ex …

    Published on 11/18/2014
  • TOP STORY: Juno files for IPO

    Less than a year after Juno Therapeutics Inc. (Seattle, Wash.) debuted with a massive series A round, the cancer immunotherapy play is looking to go public. The company on Monday filed to raise up to $150 million in an …

    Published on 11/17/2014
  • TOP STORY: EU tribunal annuls 2011 election of EMA director Rasi

    The European Union Civil Service Tribunal annulled EMA's 2011 appointment of Guido Rasi as its executive director based on an appeal of a procedural matter leading to his appointment. Deputy Executive Director Andreas …

    Published on 11/14/2014
  • TOP STORY: AstraZeneca, Isis team up on antisense delivery

    AstraZeneca plc (LSE:AZN; NYSE:AZN) and Isis Pharmaceuticals Inc. (NASDAQ:ISIS) partnered to develop new targeted delivery methods for antisense oligonucleotides with a focus on cancer and cardiovascular and metabolic …

    Published on 11/13/2014
  • 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

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