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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.

Biogen picks up another drug from wide-ranging Ionis alliance

Biogen picks up another drug from wide-ranging Ionis alliance

Ionis and Biogen’s collaboration bore its first fruit with the approval of Spinraza (nusinersen), which became the first drug to be approved in the US for spinal muscular atrophy in ... Among others in late-stage development are AB Sciences’ tyrosine

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  • Astellas, Catalyst approvals set up record year for FDA approvals Astellas, Catalyst approvals set up record year for FDA approvals

    relapse. Its approval is based on the results of the ADMIRAL in 138 patients which revealed 21% experienced a complete remission (CR) or CR with partial haematological recovery. ... The drug was originally developed by BioMarin, which got EU approval in

  • CHMP backs Sanofi’s all-oral sleeping sickness drug CHMP backs Sanofi’s all-oral sleeping sickness drug

    been backed for approval in the EU. ... Johnson &Johnson got a positive opinion on its non-metastatic castration-resistant prostate cancer (CRPC) drug Erleada (apalutamide), setting up EU approval to follow its FDA green light earlier in the

  • NICE says no to AZ and Vifor’s rival hyperkalaemia drugs NICE says no to AZ and Vifor’s rival hyperkalaemia drugs

    Vifor’s Veltassa (patiromer) gained US approval in 2015 and in Europe in 2017. ... However an initial US black box warning related to drug-drug interactions held it back, with AZ gaining  EU approval for Lokelma in March and US approval in May.

  • Shire’s angioedema drug Takhzyro recommended in Europe Shire’s angioedema drug Takhzyro recommended in Europe

    The drug isn’t the first HAE treatment on the market, however: CSL’s subcutaneous therapy Haegarda gained approval in 2017 - despite Shire's legal efforts to block it with claims ... Lanadelumab had been granted accelerated assessment by the EMA,

  • Novartis files for approval of MS drug in EU, US Novartis files for approval of MS drug in EU, US

    Novartis wants to get the new orally-active drug to patients as quickly as possible so is using a priority review voucher it earned for an earlier product approval to shorten ... the FDA’s review time – setting up a possible approval there next March.

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Latest Intelligence

  • AstraZeneca’s oncology renaissance AstraZeneca’s oncology renaissance

    from clinical trials to FDA approval in just over two years. ... On one hand, it has scored a major success this year by gaining US and EU approval as a monotherapy maintenance treatment for NSCLC patients with inoperable stage 3 disease, ie

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    platform. Led by founder and CEO John Maraganore, Alynlam finally crossed the line in August when it gained FDA and EU approval for its first drug, Onpattro. ... two entering the field at the same time. So it is with Alnlyam: Ionis and Akcea secured EMA

  • 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).

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Latest from PMHub

  • Can rare diseases be a viable option for the pharma industry?

    EU has enacted similar legislation, Regulation (EC) No 141/2000, in which pharmaceuticals developed to treat rare diseases are referred to as “orphan medicinal products”. ... Orphan drug status granted by the European Commission gives marketing

  • Exploring MINT: Part 4 - Turkey

    Turkey following FDA (US) or EMA (EU) approval. ... EU harmonisation standards, and pharmaceutical trade, as barriers to entry and export are reduced.

  • Developing your patient-centric strategy

    approval - subsequently gaining an EU licence in January.

  • 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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Health Unlimited is a global health consultancy and communications agency built by specialists with unmatched experience, perspective and expertise. For...

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AstraZeneca’s oncology renaissance
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