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PRIME status

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

First-in-class hepatitis B/D drug raises cure hope

First-in-class hepatitis B/D drug raises cure hope

It has been given a breakthrough designation by the FDA, Priority Medicines (PRIME) status by the EMA and has been awarded a Promising Innovative Medicine (PIM) designation from the MHRA in

Latest news

  • Janssen’s CAR-T gains PRIME status in Europe Janssen’s CAR-T gains PRIME status in Europe

    The EMA’s PRIME status offers enhanced interaction and early dialogue to help companies accelerate their development plans and speed up evaluation for cutting-edge therapies in areas of high unmet ... The PRIME status could help it close the gap on its

  • US, EU regulators back rapid reviews of AZ’s RSV med US, EU regulators back rapid reviews of AZ’s RSV med

    In Europe, MEDI8897 has been given PRIME status by the EMA, while the long-acting anti-RSV antibody has picked up a breakthrough designation from the FDA in the US. ... The FDA had already given the drug fast-track status, cutting its review time down to

  • Roche gains EU PRIME status for Spinraza rival Roche gains EU PRIME status for Spinraza rival

    PRIME status takes it one step closer to fruition, as it will give Roche additional support from the EMA as the company prepares and files risdiplam for approval in Europe. ... Only one in five drugs submitted for PRIME end up being awarded the status.

  • FDA clears Sobi’s Gamifant for ‘hyper-inflammation’ disease FDA clears Sobi’s Gamifant for ‘hyper-inflammation’ disease

    In Europe, emapalumab has been granted orphan designation and PRIME (PRIority MEdicine) status by the EMA, and has been filed for approval with a verdict due in 2019.

  • Orchard plans IPO as gene therapy pipeline advances Orchard plans IPO as gene therapy pipeline advances

    beta thalassaemia – which has just bagged a Priority Medicines (PRIME) designation from the EMA. ... Orchard is playing catch-up in thalassaemia with Bluebird Bio, which is planning to file its LentiGlobin candidate in Europe before the end of this year

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