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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.

Published
17 October 2014
From
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).

Published
15 October 2014
From
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.

Published
15 October 2014
From
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.

Published
15 October 2014
From
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.

Published
07 October 2014
From
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).

Published
01 October 2014
From
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.

Published
01 October 2014
From
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.

Published
25 September 2014
From
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.

Published
23 September 2014
From
The Street
US: How Insurers Are Finding Ways to Shift Costs to the Sick

Health insurance companies are no longer allowed to turn away patients because of their pre-existing conditions or charge them more because of those conditions. But some health policy experts say insurers may be doing so in a more subtle way: by forcing people with a variety of illnesses — including Parkinson’s disease, diabetes and epilepsy — to pay more for their drugs.

Published
18 September 2014
From
New York Times
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