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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.

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

EMA fast-track could help Janssen close gap. Janssen has been granted a valuable PRIME (Priority Medicines) designation from the European Medicines Agency for its CAR-T candidate for multiple myeloma, ... The PRIME status could help it close the gap on
Roche gains EU PRIME status for Spinraza rival

Oral treatment joins Novartis' gene therapy challenger. Roche has been granted PRIME (PRIority MEdicines) designation in the EU for risdiplam, its small-molecule drug for spinal muscular atrophy that could be ... Only one in five drugs submitted for

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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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