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PRIME designation

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

Novartis receives FDA breakthrough therapy designation for rare disease med

Novartis receives FDA breakthrough therapy designation for rare disease med

Swiss pharma company Novartis has received a breakthrough therapy designation (BTD) for its experimental medication iptacopan for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). ... The European Medicines Agency (EMA) has also granted

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  • Cortellis Drugs to Watch in 2020 report Cortellis Drugs to Watch in 2020 report

    The 11 drugs identified collectively hold 18 orphan drug designations, four FDA breakthrough therapy designations, two EU PRIME designations and one Japanese SAKIGAKE designation.

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

    Bluebird says its decision to file in Europe first was in part thanks to LentiGlobin being accepted on to the EMA’s PRIME fast track designation, which allows early discussions about ... Upadacitinib is already in a phase 3 trial in atopic dermatitis

  • The European Medicines Agency: PRIME’d for access? The European Medicines Agency: PRIME’d for access?

    Going for scientific advice once given the PRIME designation can also mean faster advice: a 40-day timeframe versus the 70-day standard. ... SMEs can also get a filing fee reduction. PRIME numbers after 2 years.

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

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... European regulator giving the therapy its PRIME designation in September 2016.

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