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Chronological Index of BioCentury Extra, The Daily News: Top Story

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  • TOP STORY: Reviewer backs approval of Xarelto in ACS

    An FDA reviewer recommended approval of 2.5 mg twice-daily Xarelto rivaroxaban from Johnson & Johnson (NYSE:JNJ) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS), non-ST-…

    Published on 5/21/2012
  • TOP STORY: Cancer Genetics continuing with IPO plans

    Contrary to media reports saying otherwise, Cancer Genetics Inc. (Rutherford, N.J.) has not postponed its planned IPO, according to a source familiar with the deal. The source said the market conditions are "not ideal" …

    Published on 5/18/2012
  • TOP STORY: No OS improvement for cabozantinib in MTC

    Exelixis Inc. (NASDAQ:EXEL) released an abstract showing no difference between cabozantinib and placebo in overall survival at an interim analysis in the Phase III EXAM trial in 330 patients with advanced medullary …

    Published on 5/17/2012
  • TOP STORY: Arena raises $60.5M in follow-on

    Arena Pharmaceuticals Inc. (NASDAQ:ARNA) raised $60.5 million through the sale of 11 million shares at $5.50 in a follow-on underwritten by Jefferies; Piper Jaffray; and BMO Capital Markets. The company proposed the …

    Published on 5/16/2012
  • TOP STORY: GSK to acquire Cellzome

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) will acquire the 80.02% of proteomics company Cellzome AG (Heidelberg, Germany) it does not already own for L61 million ($98 million) in cash. GSK said Cellzome's proteomic mass …

    Published on 5/15/2012
  • TOP STORY: Intercell raises EUR 35.2 million

    Intercell AG (VSE:ICLL; OTCQX:INRLY) raised EUR 35.2 million ($45.3 million) in a debt and equity financing. The financing comprised EUR 20 million ($25.8 million) in a secured loan from BB Biotech; and EUR 15.2 million…

    Published on 5/14/2012
  • TOP STORY: Arena soars on lorcaserin vote

    Arena Pharmaceuticals Inc. (NASDAQ:ARNA) jumped $2.70 (74%) to $6.36 on Friday after an FDA advisory committee voted 18-4, with one abstention, that the benefit-risk profile for Arena's lorcaserin supports approval to …

    Published on 5/11/2012
  • TOP STORY: Panel backs Truvada for HIV-1 prophylaxis

    FDA's Antiviral Drugs Advisory Committee concluded the benefit-risk profile for Truvada emtricitabine/tenofovir from Gilead Sciences Inc. (NASDAQ:GILD) supports the drug's use as pre-exposure prophylaxis (PrEP) to …

    Published on 5/10/2012
  • TOP STORY: FDA panel backs tofacitinib for RA

    FDA's Arthritis Advisory Committee voted 8-2 in favor of recommending approval of tofacitinib from Pfizer Inc. (NYSE:PFE) to treat moderately to severely active rheumatoid arthritis (RA) in patients who have had …

    Published on 5/9/2012
  • TOP STORY: Actelion refocusing R&D, reducing costs

    Actelion Ltd. (SIX:ATLN) said it plans to reduce R&D and overhead spending by refocusing R&D activities on specialty areas and out-licensing its primary care programs. Actelion did not provide details on specific cuts.…

    Published on 5/8/2012
  • TOP STORY: Roche discontinues dalcetrapib

    Roche (SIX:ROG; OTCQX:RHHBY) lost CHF5 billion ($5.4 billion) in market cap on Monday after discontinuing development of cardiovascular compound dalcetrapib. The pharma, which now has a market cap of CHF138.6 billion ($…

    Published on 5/7/2012
  • TOP STORY: FDA questions Arcalyst for gout

    FDA reviewers said Arcalyst rilonacept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) had a "small" treatment effect to prevent gout flares in adults initiating uric acid-lowering therapy and that the drug appears to…

    Published on 5/4/2012
  • TOP STORY: Royalty Pharma buys BG-12 interest

    Royalty Pharma (New York, N.Y.) paid former shareholders of Fumapharm AG $761 million in cash to acquire a portion of earn-out rights related to multiple sclerosis (MS) product BG-12 and psoriasis drug Fumaderm. The …

    Published on 5/3/2012
  • TOP STORY: H5N1 transmissibility paper published

    Nature published a revised version of the first of two studies on H5N1 transmissibility in mammals on Wednesday after over four months of debate among academics and government officials about the potential for misuse of…

    Published on 5/2/2012
  • TOP STORY: FDA approves taliglucerase

    FDA approved an NDA late Tuesday from Pfizer Inc. (NYSE:PFE) for Elelyso taliglucerase alfa to treat Type I Gaucher's disease. The news sent shares of partner Protalix Biotherapeutics Inc. (NYSE-A:PLX; Tel Aviv:PLX) up…

    Published on 5/1/2012
  • TOP STORY: Actelion up on macitentan data

    Actelion Ltd. (SIX:ATLN) gained CHF4.60 (14%) to CHF38.40 on Monday after macitentan met the primary endpoint of reducing a composite of time to first morbidity or mortality event vs. placebo in the Phase III SERAPHIN …

    Published on 4/30/2012
  • TOP STORY: Boehringer breaks off German pricing talks

    Boehringer Ingelheim GmbH (Ingelheim, Germany) told BioCentury it broke off pricing negotiations with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) for diabetes drug Trajenta linagliptin. …

    Published on 4/27/2012
  • TOP STORY: Jazz tunes into cancer with EUSA buy

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) will acquire cancer-focused specialty pharma EUSA Pharma Inc. (Langhorne, Pa.) for $650 million in cash, plus a potential $50 million payment tied to 2013 U.S. sales of EUSA's …

    Published on 4/26/2012
  • TOP STORY: Amgen buying Turkish pharma

    Amgen Inc. (NASDAQ:AMGN) said it will acquire 95.6% of Mustafa Nevzat Pharmaceuticals A.S. (Istanbul, Turkey) in a cash deal that values the Turkish pharma at $700 million. Mustafa Nevzat, which recorded about $200 …

    Published on 4/25/2012
  • TOP STORY: Biotech pioneer Rathmann passes away

    Amgen Inc. (NASDAQ:AMGN) said founding CEO George Rathmann died Sunday. Rathmann, 84, had suffered from kidney failure. He was Amgen's founding CEO from 1980-88 and chairman until 1990. He later co-founded and was …

    Published on 4/24/2012
  • TOP STORY: AstraZeneca to buy Ardea for $1.3 billion

    AstraZeneca plc (LSE:AZN; NYSE:AZN) will acquire Ardea Biosciences Inc. (NASDAQ:RDEA) for $32 per share, or about $1.3 billion. The price is a 54% premium to Ardea's close of $20.84 on Friday, before the deal was …

    Published on 4/23/2012
  • TOP STORY: CHMP backs dapagliflozin

    EMA's CHMP issued several positive opinions on Friday, including one in favor of Forxiga dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat Type II diabetes. …

    Published on 4/20/2012
  • TOP STORY: HGSI rejects GSK bid

    Human Genome Sciences Inc. (NASDAQ:HGSI) rejected an unsolicited takeover offer from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for $13 per share, or about $2.6 billion in cash. The price is an 81% premium to Human…

    Published on 4/19/2012
  • TOP STORY: PDUFA discussion drafts released

    The U.S. House Energy and Commerce Committee released a discussion draft of PDUFA reauthorization legislation on Wednesday. The Senate Health, Education, Labor and Pensions Committee also posted draft versions of PDUFA …

    Published on 4/18/2012
  • TOP STORY: GSK, Five Prime in second discovery deal

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Five Prime Therapeutics Inc. (South San Francisco, Calif.) partnered to identify targets and drug candidates relevant to refractory asthma and chronic obstructive pulmonary …

    Published on 4/17/2012

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