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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Tag: tezacaftor
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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FDA expansion for Symdeko in cystic fibrosis
The indication is now for pediatric patients ages six years and older with certain genetic mutations.
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Vertex’ three-drug CF combo hits PhIII targets
Vertex’ three-drug cystic fibrosis regimen – combining the investigational next-generation corrector VX-445 with Kalydeco (ivacaftor) and tezacaftor – has achieved primary endpoints of two Phase III studies in patients the condition.
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EU approves Vertex’ cystic fibrosis combo
The European Commission has approved Vertex’ Symveki in a combination regimen with Kalydeco to treat certain patients with cystic fibrosis (CF).
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Vertex to test CF triple combo therapy in Phase III trials
Vertex Pharmaceuticals will begin testing a combination of VX-445, tezacaftor and ivacaftor as a potential treatment for people with cystic fibrosis (CF) in two Phase III studies.
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Vertex secures US approval for Symdeko
US regulators have approved Vertex’ Symdeko, a combination of Kalydeco (ivacaftor) and tezacaftor, to treat certain patients with cystic fibrosis (CF).
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Vertex files new CF combo in the US, EU
Regulators on both sides of the Atlantic are reviewing Vertex’ experimental tezacaftor/ivacaftor combination therapy for cystic fibrosis.
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‘Compelling’ mid-stage data for Vertex’ CF drugs
Vertex Pharmaceuticals has unveiled “compelling data” from Phase I and Phase II studies assessing three experimental triple combination regimens for patients with certain forms of cystic fibrosis (CF).
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