Vertex receives CHMP positive opinion for Kaftrio in children with cystic fibrosis
Those eligible will have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
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Tag: Kaftrio
EMA, MHRA to review Vertex’ Kaftrio for children with CF
If approved, up to 2,000 children with CF would be eligible for treatment with the drug
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MHRA approves label extension for Vertex’s Kaftrio combo
Extension of indication expands access to drug for additional cystic fibrosis patients in Great Britain
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Triple combo cystic fibrosis therapy Kaftrio scores EU label expansion
Extension means the ‘majority’ of people aged 12 years and older with CF in Europe can now access therapy
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EU nod for Vertex CF therapy Kaftrio
Clearance was based on two global Phase III studies showing statistically significant improvements in lung function
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Vertex and NHS Wales agree on Kaftrio reimbursement
The letter of intent should secure access to the combination for people with cystic fibrosis upon its regulatory approval
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Vertex signs ‘landmark’ deal with NHS for CF therapy
CF patients in England will be among the first in Europe to benefit from access to Kaftrio, if the medicine is approved by the EC
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Eight medicines leap towards EU approval
The recommendations include a conditional approval for Gilead’s Veklury (remdesivir) for COVID-19
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- Kahimmune Therapeutics enters licensing agreement with Gustave Roussy and SATT Paris-Saclay
- IBSA UK&I launches Perovial for the treatment of acute Peyronie’s disease
- En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
- ALK’s EURneffy receives positive CHMP opinion for emergency anaphylaxis treatment in children
- CERo reports encouraging early data from phase 1 trial of CER‑1236
