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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.

Sanofi gets cardio outcomes claim for Praluent in EU

Sanofi gets cardio outcomes claim for Praluent in EU

Data stronger than rival's, could spark a fight back. The EU has approved a cardiovascular outcomes claim for Sanofi’s cholesterol-lowering antibody Praluent, finally setting it on par with ... Praluent may have won approval later, but analysts have

Latest news

  • Keytruda adds another NSCLC approval in Europe Keytruda adds another NSCLC approval in Europe

    Squamous NSCLC completes first-line dominance. The European Commission has granted MSD's Keytruda approval in another major lung cancer setting. ... Keytruda's closest competitor in first line NSCLC treatment is Roche's Tecentriq, which recently gained

  • Trulicity’s ascent lifts Lilly Trulicity’s ascent lifts Lilly

    The drug is approved in the US for patients with the NTRK gene mutation, most commonly seen in cancers of the salivary gland, thyroid, lung and soft tissue sarcoma, with EU ... Meanwhile, in Europe, the company gained EU-wide approval in November for

  • Pfizer closes on EU approval of lung cancer drug Vizimpro Pfizer closes on EU approval of lung cancer drug Vizimpro

    And AZ claims first with Forxiga in T1 diabetes. Among the clutch of decisions at the last CHMP meeting was a recommendation for approval of Pfizer’s Vizimpro, an EGFR-targeting ... up a full EMA approval in the coming weeks.

  • Vertex gains EU approval for earlier Orkambi use Vertex gains EU approval for earlier Orkambi use

    This makes Orkambi the first treatment available in Europe to treat these young children whose CF, who number around 1, 500 in the EU. ... The approval was based on phase 3 data, whereby Orkambi was general well tolerated for 24 weeks in 60 patients

  • J&J’s Erleada cleared for early prostate cancer in Europe J&J’s Erleada cleared for early prostate cancer in Europe

    Signals competiton for Xtandi. Johnson &Johnson has bagged EU approval for Erleada for non-metastatic, castration-resistant prostate cancer (nmCRPC), setting up a market challenge with Astellas and Pfizer’s Xtandi. ... The new indication comes almost a

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Latest Intelligence

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    EU approval follows a green light in the US in August. ... for approval in the US and EU for non-metastatic CRPC on the strength of MFS data from the PROSPER trial.

  • 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.

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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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