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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.

Novartis files for approval of MS drug in EU, US

Novartis files for approval of MS drug in EU, US

Novartis files for approval of MS drug in EU, US. Siponimod could achieve blockbuster status if approved, says analysts. ... the FDA’s review time – setting up a possible approval there next March.

Latest news

  • Alnylam seeks fast-track filing with biomarker data Alnylam seeks fast-track filing with biomarker data

    After 15 years building its RNAi ‘gene silencing’platform, the Cambridge, Massachusetts based biotech gained its first US and EU regulatory approval with Onpattro last month, but now looks set to ... FDA. , and hope to file at or around year-end 2018,

  • Roche’s Tecentriq misses survival mark in frontline NSCLC Roche’s Tecentriq misses survival mark in frontline NSCLC

    The EU approval is for patients who have no EGFR or ALK mutations in their tumours, and was based on promising OS and PFS data from the phase 3 KEYNOTE-189

  • MSD wins key EU approval for Keytruda, Alimta combo MSD wins key EU approval for Keytruda, Alimta combo

    MSD wins key EU approval for Keytruda, Alimta combo. Decision keeps Keytruda well ahead of rival Tecentriq. ... Immunotherapy blockbuster Keytruda has received another boost with the European approval of its use in combination with Lilly’s Alimta plus

  • Darzalex powers ahead with frontline myeloma approval in Europe Darzalex powers ahead with frontline myeloma approval in Europe

    Its pharma division Janssen has gained EU approval for its use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for newly-diagnosed myeloma patients who are ineligible for high-dose ... patients. The EU approval follows a nod

  • Alnylam gets EU nod for Onpattro amid pricing backlash Alnylam gets EU nod for Onpattro amid pricing backlash

    Ionis and Akcea secured EMA approval last month for their antisense candidate Tegsedi (inotersen), but are still in the process of negotiating price and reimbursement with individual EU countries, while ... The EU approval follows a positive

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Latest Intelligence

  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    This means the out-of-pocket cost for healthcare has fallen, just as the government is accelerating marketing approval and reimbursement for priority medicines. ... Its Imfinzi has secured the first-ever US and EU approval in locally- advanced,

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    Bluebird are also likely to get the chance to benchmark their price against Spark’s Luxturna which is on course to gain EU approval by the end of 2019. ... Spark's Luxturna: already approved in the US, expected to gain EU approval by late 2018.

  • 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

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Latest from PMHub

  • 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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