cystic fibrosis

Showing 15 posts of 43 posts found.

Vertex announces positive results from trial for cystic fibrosis combination treatment

February 6, 2024
Research and Development Chronic Diseases, Vertex pharmaceuticals, clinical trial, combination treatment, cystic fibrosis

Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor programme, the company’s phase 3 programme for the treatment of …

Arcturus Therapeutics gains FDA ODD for cystic fibrosis treatment

November 28, 2023
Research and Development Arcturus Therapeutics, Chronic Diseases, FDA, ODD, cystic fibrosis

Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARCT-032, …

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Vertex applies to expand indication of cystic fibrosis drug

May 20, 2021
EMA, MHRA, cystic fibrosis

Vertex has announced that the EMA and MHRA have validated the post marketing applications for an expanded indication of Kaftiro …

EC approves Kaftrio as combination treatment for cystic fibrosis

April 29, 2021
EU, European Commission, cystic fibrosis

Vertex Pharmaceuticals has been granted European Commission approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with …

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Polyphor granted Clinical Trial Authorisation for inhaled antibiotic

December 22, 2020
Manufacturing and Production Polyphor, cystic fibrosis

Polyphor, a Swiss clinical-stage biopharmaceutical company, has announced that the MHRA has granted a Clinical Trial Authorisation (CTA) to begin …

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Vertex scores EU approval for cystic fibrosis drug Kalydeco in R117H+ children and adolescents

June 10, 2020
Research and Development, Sales and Marketing Kalydeco, Vertex, cystic fibrosis, ivacaftor, pharma

Vertex has revealed that it has secured a new approval from the European Commission for its therapy Kalydeco (ivacaftor) in …

Vertex’s Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

May 1, 2020
Medical Communications, Sales and Marketing Europe, Kalydeco, Vertex, cystic fibrosis

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the approval …

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FDA approves Vertex’s Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients

October 23, 2019
Research and Development, Sales and Marketing FDA, Trikafta, Vertex, cystic fibrosis, pharma

The FDA has granted marketing authorisation to Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), it …

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Vertex cystic fibrosis drugs become available in Scotland after NHS rejection

September 12, 2019
Sales and Marketing SMC, Vertex, cystic fibrosis

Two potentially life-changing cystic fibrosis drugs are to become available for a potential pool of 400 patients in Scotland just …

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Scotland turns down Vertex’s Orkambi

August 13, 2019
Manufacturing and Production Orkambi, SMC, Scotland, Vertex, cystic fibrosis, pharma

The Scottish Medicines Consortium (SMC) has turned down Vertex’ cystic fibrosis drug Orkambi on the grounds that it is not …

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FDA expands Vertex’s cystic fibrosis drug Symdeko in paediatric patients

June 24, 2019
Sales and Marketing FDA, Symdeko, Vertex, cystic fibrosis, pharma

Vertex has announced that the FDA has chosen to expand the existing authorisation on its cystic fibrosis (CF) therapy Symdeko …

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Parents of children with cystic fibrosis start Orkambi buyers club

June 5, 2019
Research and Development NHS, Orkambi, Vertex, cystic fibrosis

Parents of children with cystic fibrosis have started an Orkambi buyers’ club to import generic versions of Vertex’s drug from …

The price of access: Can the NHS afford Orkambi?

April 29, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Drug pricing, NHS, NICE, Orkambi, UK, Vertex, access, cystic fibrosis, feature, pharma, pricing

The impasse over access to Vertex’s Orkambi for cystic fibrosis patients in England and Wales has revealed the cracks in …

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Vertex destroyed nearly 8,000 packs of Orkambi in 2018

March 28, 2019
Medical Communications, Sales and Marketing Briatin, Orkambi, UK, Vertex, cystic fibrosis

Vertex destroyed nearly 8,000 packs of the $272,000 a year cystic fibrosis drug Orkambi in 2018, the company said in …

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Vertex doubles Q4 profits, angering cystic fibrosis drug advocates in UK

February 11, 2019
Sales and Marketing Orkambi, Vertex, cystic fibrosis, pharma

Despite ongoing controversy surrounding the currently stalled negotiations between Vertex and the NHS to make its cystic fibrosis (CF) drug …

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