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Priority Medicines
This page shows the latest Priority Medicines news and features for those working in and with pharma, biotech and healthcare.
FDA priority review granted for J&J, Legend Biotech’s myeloma CAR T therapy
Today’s priority review designation marks another significant milestone for this cell therapy,” said Ying Huang, chief executive officer and chief financial officer of Legend Biotech. ... In December 2019, the European Commission also granted
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FDA sets January decision date for Xalkori in ALK-positive lymphoma
Pfizer’s tyrosine kinase inhibitor (TKI) Xalkori has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of paediatric ALK-positive anaplastic large cell ... In addition to the FDA priority review, the European
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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 ... Even with recent progress to deliver new
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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)
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Provention Bio wins PRIME designation for type 1 diabetes prevention drug
Meanwhile J&J partnered Crohn's drug flops in phase 2. Provention Bio has announced its lead candidate PRV-031 (teplizumab) has been granted Priority Medicines (PRIME) designation from the European ... data. A PRIME designation gives medicines priority
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Significant gaps remain in UK’s no-deal Brexit prep, says NAO report
shortages of vital medicines, despite the “great deal of work” undertaken by the government and the pharma industry. ... He welcomed the confirmation by the government that medicines get top priority for the additional freight capacity, but said
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China: AstraZeneca’s new engine for growth and innovation
In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA)’s Priority Review pathway, ... This means the out-of-pocket cost for healthcare has fallen,
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The European Medicines Agency: PRIME’d for access?
The European Medicines Agency (EMA) is no different offering five routes that can hasten approval, under certain conditions. ... The most recently added – the PRIority Medicines (PRIME) scheme – reached its two-year anniversary in March 2018.
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Bluebird Bio: on the cusp of a gene therapy revolution
The sickle cell programme has also been named on the FDA’s Regenerative Medicine Advanced Therapy designation (RMAT), a new fast-track specifically aimed at helping these cutting edge medicines gain ... PRIME (The PRIority Medicines scheme) provides
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The real-world data conundrum
Regardless of what the actual total costs are, though, it is certain that, with very few exceptions, the era of blockbuster drugs is over and the demand for stratified medicines, affordable ... diseases. At a more fundamental level, though, availability
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Europe vs the US: New drug product approvals
In the first quarter of 2016, the EMA launched a scheme for PRIority MEdicines (PRIME), to optimise development plans and provide accelerated assessment for medicines that are of major interest for ... In 2016 special approval pathways and designations
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