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EU approval

This page shows the latest EU approval news and features for those working in and with pharma, biotech and healthcare.

AZ finally gets EU nod for Veltassa rival Lokelma

AZ finally gets EU nod for Veltassa rival Lokelma

AstraZeneca has at long last won EU approval for Lokelma as an oral treatment for high potassium levels, more than a year after it was backed by the EMA’s Committee ... delaying approval and giving Vifor time to consolidate its position in the market.

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  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    This indicates that applying for approval in the US prior to registration in the EU still remains a regular practice. ... pending approval by the European Commission (EC) in January 2017 (compared to no biosimilars gaining EU approval in 2015).

  • A rare opportunity A rare opportunity

    Sobi, handing Sobi commercialisation control over the haemophilia A treatment just four months after it received EU approval.

  • The price is right? The price is right?

    Best practice is to engage a specialist partner around 1.5 years prior to EU approval - and to take a collaborative and transparent approach to developing an agile market access strategy.”. ... This alone should sharpen industry thinking and reinforce

  • Choices, choices: the rapidly evolving HIV treatment landscape Choices, choices: the rapidly evolving HIV treatment landscape

    Viiv's Triumeq is now following a similar pattern. Although it gained EU approval in September 2014, it has only launched in Germany and the UK so far. ... With Triumeq signalling the approval of the first STR without tenofovir disoproxil fumarate (TDF)

  • Pharma deals during April 2014 Pharma deals during April 2014

    franchise. The icing on the cake is Bexsero for the prevention of meningitis B, which has EU approval and orphan drug designation in the US. ... which comes off patent next month and the first to market approval for Diovan, Novartis' blood pressure drug.

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  • vector pharma

    vector pharma. vector pharma specialises in the provision of close strategic regulatory support to innovative small to medium-size development-phase pharma companies seeking product approval within the EU.

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