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    1. Gilead Sciences: Pricing, Politics And Profits

      Headlines

      Tue, 21 Oct 2014

      Gilead Sciences (NASDAQ: GILD ), and a commenter requested an article about the politics surrounding Gilead's pricing of its Hep C drugs Sovaldi, and more recently, Harvoni. So, I began going through various articles, news reports and company statements

    2. FDA clears Gilead hep C combo pill

      Headlines

      Fri, 10 Oct 2014

      The FDA approves Gilead Sciences' ( GILD -0.3% ) Harvoni for the treatment of chronic hepatitis C genotype 1 infection. Harvoni is a combination of ledipasvir and sofosbuvir . It is the first approved regimen that does not require administration with interferon or ribavirin. This is the third HCV

    3. Arrowhead plunges on hep B drug data

      Headlines

      Wed, 8 Oct 2014

      Micro cap Arrowhead Research ( ARWR -51% ) plunges on massive turnover of 35M shares in response to its disclosure of Phase 2 trial results for its experimental hepatitis B therapy, ARC-520 . In data released in the "Late-breaking abstracts" section of the American Association For The Study Of ...

    4. Called Strike 3 For Bristol-Myers Squibb: What This Says For Gilead And Its Competitors In The Hep C Market

      Headlines

      Wed, 8 Oct 2014

      By Pharma Doc : Background: The hepatitis C landscape is an extremely competitive area for pharmaceuticals and biotechs. Years ago, the standard of care for HCV genotype 1 patients was Pegasys and Ribavirin for 48 weeks of treatment. Side effects were very bad (nausea and flu-like symptoms), and ...

    5. PDUFA date approaches for Gilead hep C combo

      Headlines

      Tue, 7 Oct 2014

      The FDA's PDUFA date for its review of Gilead Sciences' ( GILD -0.1% ) NDA for the combination of ledipasvir and sofosbuvir for the treatment of hepatitis C genotype 1 infection in adults is October 10. The European Medicines Agency's CHMP adopted a positive opinion recommending approval for the ...

    6. UPDATE 2-Bristol-Myers pulls U.S. marketing application for hep C treatment

      Headlines

      Tue, 7 Oct 2014

      (Adds comment from Bristol-Myers and analyst, adds background, updates shares)

    7. Bristol-Myers pulls hep C NDA

      Headlines

      Tue, 7 Oct 2014

      BMY ) decides not to pursue U.S. regulatory approval of the dual regimen of daclatasvir and asunaprevir for the treatment of hep C 1b. As a result, it withdraws its NDA for its NS3/4A protease inhibitor , asunaprevir. The company will continue to pursue

    8. The Question Isn't If Gilead's Hep C Combo Will Be Approved In The US By Next Friday; The Question Is The Price Of The Regimen

      Headlines

      Fri, 3 Oct 2014

      By Pharma Doc : Background: Gilead's (NASDAQ: GILD ) Sofosbuvir (Sovaldi) was approved by the FDA in late 2013 and has shattered the record for the best drug launch in history. In its first two quarters, Sovaldi has sold $5.7B and is anticipated to sell $10-$12B in 2014. Gilead's current regimen ...

    9. France to tax hep C drug makers in order to curb costs

      Headlines

      Tue, 30 Sep 2014

      selected hepatitis C drug makers if the cost to the government exceeds a certain amount each year. If social security spending on hep C drugs exceeds €450M in 2014, the drug makers will be taxed based on the revenue that exceeds the cap. The cap in 2015

    10. Gilead submits marketing app in Japan for Hep C combo

      Headlines

      Wed, 24 Sep 2014

      approved, the single tablet will eliminate the need for interferon and ribavirin. More than 1M people in Japan have chronic hep C. As many as 80% are infected with type 1. On June 27, 2014 Gilead submitted an NDA to the PMDA for Sovaldi (sofosbuvir

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