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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

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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EMA fast-tracks review of bluebird bio’s LentiGlobin for sickle cell disease

Gene therapy has been given a PRIME designation. Biotech company bluebird bio has been awarded a priority medicines (PRIME) designation by the European Medicines Agency (EMA) for its gene therapy LentiGlobin ... The PRIME designation shows the importance
FDA hands BMS and bluebird bio a priority review for ide-cel

Following the acceptance of the application and priority review designation, the FDA has set a Prescription Drug User Fee Act (PDUFA) date of 27 March 2021, setting up a potential launch ... Ide-cel has been awarded a Priority Medicines (PRIME)
GSK files anti-BCMA drug for myeloma after second trial win

The ADC has been given a breakthrough designation by the FDA as well as PRIME designation from the EMA in Europe.
Provention Bio wins PRIME designation for type 1 diabetes prevention drug

data. A PRIME designation gives medicines priority and provides them with special support – this includes enhanced interaction and dialogue, and an accelerated evaluation and review. ... We are very pleased the EMA recognises the transformative
A first for Bluebird and Europe as gene therapy Zynteglo approved

This was thanks to the EMA’s PRIME designation, a fast-track appraisal system particularly focused on cutting edge therapies from smaller-to-medium sized pharma and biotech firms.

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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

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?

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

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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