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

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  • TOP STORY: Cempra raises $50.4M in IPO

    Antibiotics company Cempra Inc. (NASDAQ:CEMP) raised $50.4 million through the sale of 8.4 million shares at $6 in an IPO. The price values Cempra at $118.6 million. Last month, the company said it planned to sell 6 …

    Published on 2/3/2012
  • TOP STORY: Agennix falls on severe sepsis data

    Agennix AG (Xetra:AGX) fell EUR 0.81 (30%) to EUR 1.88 on Thursday after talactoferrin plus standard of care led to an increased 28-day all-cause mortality, the primary endpoint, compared to standard of care alone in …

    Published on 2/2/2012
  • TOP STORY: Savient's Johnson leaves for Dendreon

    John Johnson resigned as president and CEO of Savient Pharmaceuticals Inc. (NASDAQ:SVNT) to become president, CEO and chairman-elect of Dendreon Corp. (NASDAQ:DNDN). Johnson succeeds Mitchell Gold, who will serve as …

    Published on 2/1/2012
  • TOP STORY: FDA approves Vertex's CF drug

    FDA approved Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis in patients aged six and older who have at least one copy of the G551D mutation in the cystic fibrosis …

    Published on 1/31/2012
  • TOP STORY: FDA approves vismodegib for BCC

    FDA approved once-daily oral Erivedge vismodegib from Genentech Inc. to treat advanced basal cell carcinoma (BCC). The approval, which came ahead of the March 8 PDUFA date, triggers a $10 million milestone payment from …

    Published on 1/30/2012
  • TOP STORY: Verastem raises $55M in bumped-up IPO

    Preclinical cancer company Verastem Inc. (NASDAQ:VSTM) raised $55 million through the sale of 5.5 million shares at $10 per share in a bumped-up IPO. The price values Verastem at $202.3 million. Earlier this month, the …

    Published on 1/27/2012
  • TOP STORY: Amgen to acquire Micromet for $1.2B

    Amgen Inc. (NASDAQ:AMGN) will acquire Micromet Inc. (NASDAQ:MITI) for $11 per share in cash, or about $1.2 billion. The price is a 33% premium to Micromet's close of $8.28 on Wednesday, before the deal was announced. …

    Published on 1/26/2012
  • TOP STORY: Roche makes hostile bid for Illumina

    Roche (SIX:ROG; OTCQX:RHHBY) made an unsolicited offer to acquire sequencing and microarray company Illumina Inc. (NASDAQ:ILMN) for $44.50 per share, or about $5.7 billion in cash. The price is an 18% premium to …

    Published on 1/25/2012
  • TOP STORY: Romney says he'll repeal 'Obamacare'

    "Governor Romney can and will repeal 'Obamacare' and is committed to doing so," Mitt Romney campaign spokesperson Andrea Saul told BioCentury on Tuesday. Saul was responding to comments former Minnesota GOP Senator Norm…

    Published on 1/24/2012
  • TOP STORY: PCORI releases broad research agenda

    The Patient-Centered Outcomes Research Institute released its draft research priorities and agenda on Monday but did not specify which conditions or treatments would be studied. PCORI, which was established by the …

    Published on 1/23/2012
  • TOP STORY: FDA approves JCV test for Tysabri

    FDA approved the Stratify JCV Antibody ELISA test to stratify the risk of developing progressive multifocal leukoencephalopathy (PML) in patients receiving autoimmune drug Tysabri natalizumab. The agency also approved a…

    Published on 1/20/2012
  • TOP STORY: 4SC jumps on resminostat data in HCC

    4SC AG (Xetra:VSC) jumped EUR 0.57 (39%) to EUR 2.05 on Thursday after resminostat alone and in combination with Nexavar sorafenib met the primary endpoint of at least a 20% progression-free survival rate in the Phase …

    Published on 1/19/2012
  • TOP STORY: RaNA Therapeutics debuts

    Newco RaNA Therapeutics Inc. (Cambridge, Mass.) formally debuted Wednesday and said it raised $2.7 million last November in the first tranche of a secured $20.7 million A round. The round is being co-led by Atlas …

    Published on 1/18/2012
  • TOP STORY: Verastem, Cempra set IPO ranges

    Preclinical cancer company Verastem Inc. (Cambridge, Mass.) and antibiotics company Cempra Holdings LLC (Chapel Hill, N.C.) set price ranges on Tuesday for their respective IPOs. Verastem plans to sell 4.5 million …

    Published on 1/17/2012
  • TOP STORY: Adcetris receives boxed PML warning

    FDA and Seattle Genetics Inc. (NASDAQ:SGEN) updated the label of cancer drug Adcetris brentuximab to include a boxed warning about the risk of JC virus infection resulting in progressive multifocal leukoencephalopathy (…

    Published on 1/13/2012
  • TOP STORY: Hearings set for PDUFA, biosimilars

    The U.S. House Energy and Commerce Committee's health subcommittee announced a series of hearings in February on the PDUFA and MDUFA reauthorizations, as well as the biosimilar and generic drug user fee proposals. A …

    Published on 1/12/2012
  • TOP STORY: AstraZeneca partners with IMS Health

    IMS Health will provide AstraZeneca plc (LSE:AZN; NYSE:AZN) access to health outcomes data in Europe under a three-year partnership announced Wednesday. AstraZeneca will use the data, which includes clinical outcome, …

    Published on 1/11/2012
  • TOP STORY: LIFE, ILMN unveil new sequencers

    Life Technologies Corp. (NASDAQ:LIFE) and Illumina Inc. (NASDAQ:ILMN) on Tuesday each unveiled next-generation DNA sequencing systems that boast the ability to sequence the entire human genome in about one day. Life …

    Published on 1/10/2012
  • TOP STORY: Bristol-Myers to acquire Inhibitex

    Bristol-Myers Squibb Co. (NYSE:BMY) will acquire HCV play Inhibitex Inc. (NASDAQ:INHX) for $26 per share in cash, or $2.5 billion. The price is a 163% premium to Inhibitex's close of $9.87 on Friday, before the deal was…

    Published on 1/9/2012
  • TOP STORY: CDER creating medical policy board

    FDA is creating a medical policy board at the Center for Drug Evaluation and Research to enhance the consistency of medical policies, CDER Director Janet Woodcock told BioCentury. Woodcock, who announced the initiative …

    Published on 1/6/2012
  • TOP STORY: Cowen Royalty closes $1B fund

    Cowen Healthcare Royalty Partners closed its second fund, Cowen Healthcare Royalty Partners II, at $1 billion. The firm said the fund, which exceeded its initial target by more than 75%, is the largest private equity …

    Published on 1/5/2012
  • TOP STORY: Biogen Idec gains option to ISIS-SMNRx

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS) granted Biogen Idec Inc. (NASDAQ:BIIB) an exclusive, worldwide option to develop and commercialize ISIS-SMNRx, which is in Phase I testing to treat spinal muscular atrophy (SMA). …

    Published on 1/4/2012
  • TOP STORY: Teva names Levin CEO

    Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) hired Jeremy Levin as president and CEO, effective in May. Levin was SVP of strategy, alliances and transactions at Bristol-Myers Squibb Co. (NYSE:BMY). He succeeds …

    Published on 1/3/2012
  • TOP STORY: Expanded label for Prevnar 13

    FDA granted accelerated approval to Prevnar 13 from Pfizer Inc. (NYSE:PFE) to prevent pneumococcal disease in adults 50 years and older. FDA approved the product based in part on two Phase III trials that evaluated an …

    Published on 12/30/2011
  • TOP STORY: FDA unveils REMS for fentanyl drugs

    FDA approved a single REMS for the class of transmucosal immediate-release fentanyl pain drugs to reduce the risk of misuse, abuse, addiction and overdose. The shared REMS, which takes effect in March, will replace …

    Published on 12/29/2011

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