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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.

CTI slumps as Servier-partnered lymphoma drug fails

CTI slumps as Servier-partnered lymphoma drug fails

Shares in CTI were suspended as the news broke but slumped after trading resumed as investors came to terms with both a threat to the drug’s EU approval, and little ... The Seattle-based company has said for some time that any development of the drug

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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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