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  • GlaxoSmithKline weighs an IPO for HIV-focused ViiV as it sharpens the budget axe

    In the preamble to GSK's latest earnings statement, CEO Andrew Witty heralded the progress of ViiV, majority-owned by his company, since its foundation 5 years ago. Now, as ViiV enters the commercialization phase and continues building its pipeline, it might benefit from access to public markets, according to Witty. What that might mean in specific terms remains up in the air, and it's unclear whether GSK is considering selling off shares of only its own stake in the business.

    22 October 2014 | FierceBiotech
  • Juncker seen making U-turn on medicines policy

    Jean-Claude Juncker has ceded to pressure from MEPs and abandoned his plan to return control of medicines and pharmaceutical products to the Industry Commissioner. This responsibility will instead remain in the hands of the Health Commissioner.

    17 October 2014 | EurActiv
  • Unique 'pay if you clear' proposal for new hepatitis drug

    The NHS in Scotland could be reimbursed for the cost of a new hepatitis drug if sufferers fail to clear the virus. The novel proposal was revealed after the drug Olysio was cleared for use by the Scottish Medicines Consortium (SMC).

    15 October 2014 | BBC
  • Fair Pricing Coalition Urges a Uniform Price for Curative Hepatitis C Treatment

    The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni™ (sofosbuvir and ledipasvir) should be extended to 12 and 24-week curative treatment durations.

    15 October 2014 | Fair Pricing Coalition
  • If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point?

    Now that the FDA has approved the Harvoni treatment from Gilead Sciences and a $94,500 price for a 12-week regimen has been established, attention is turning toward AbbVie and the steps the big drug maker must take to win market share. Already, though, some Wall Street prognosticators believe AbbVie may find it daunting.

    15 October 2014 | Wall Street Journal
  • In a surprise move, Bristol-Myers drops U.S. approval plans for hep C drug

    After sizing up the competitive landscape as rival Gilead ($GILD) races ahead with a new combo treatment, Bristol-Myers has opted to drop its application to gain an approval in the U.S. for asunaprevir, its NS3/4A protease inhibitor, and won't go after an OK to use a combination of daclatasvir and asunaprevir for genotype 1b patients.

    07 October 2014 | Fierce Biotech
  • Europe: Pharma industry denies it lobbied for medicines to move to DG Enterprise

    Europe’s pharmaceutical industry has said it did not lobby for medicines and medical devices to be moved from the European Commission's health directorate (DG Sanco) to the enterprise directorate (DG Enterprise).

    01 October 2014 | EurActiv
  • J&J makes a splash in hep C with a $1.75B deal for Alios

    Johnson & Johnson ($JNJ) is taking a deep dive into antivirals, trading $1.75 billion for private biotech Alios BioPharma to get its hands on a midstage treatment and some early assets that could expand its share of the blockbuster hepatitis C market.

    01 October 2014 | Fierce Biotech
  • Gilead’s investigational tenofovir alafenamide (TAF)-based single tablet HIV regimen meets 48-week primary objective in two Phase 3 studies

    The studies demonstrated that the single tablet regimen comprising elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), was non-inferior to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy. In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild.

    25 September 2014 | Gilead press release
  • Gilead Sciences: A Preview of Important HIV Drug Study Results

    Gilead is running nine phase III studies involving tenofovir alafenamide (TAF), which reflects the importance of the drug to Gilead's future HIV business. It is collecting an enormous amount of clinical data in which to make the case that TAF should be a preferred backbone drug for new and existing HIV patients, as well as patients who cannot use Viread because of pre-existing kidney conditions.

    23 September 2014 | The Street
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