Tags : Cystic Fibrosis (CF)

Vertex Pharmaceuticals’ Orkambi (lumacaftor+ivacaftor) Receives EU Approval for Cystic Fibrosis

Vartika Singh January 21, 2019

Shots: The approval is based on two P-III clinical study result assessing Orkambi in 60 patients with CF + 2 copies of F508del mutation, in Children Aged 2 to 5 The studies demonstrated an improvement in sweat chloride, 2 EP @24 weeks (mean decrease in sweat chloride from baseline of 31.7 mmol/L; 95% CI: -35.7, […]Read More

Regulatory

Vertex’s Kalydeco (ivacaftor) Receives FDA’s Expanded Label Approval for Cystic

Vartika Singh November 30, 2018

Shots: The approval is based on the results of ongoing P-III ARRIVAL study assessing Kalydeco in patients who have either of 10 mutations in the CFTR gene (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H) Results: mean sweat chloride level @ 24 wks. 33.8 mmol/L; mean absolute change -73.5 mmol/L; presented at […]Read More

Evotec Signs a License Agreement with Kazia Therapeutics for Clinical Development of EVT801

Boehringer Ingelheim and MD Anderson Expand their Collaboration to Accelerate Targeted Therapies for Lung Cancer

Spark Therapeutics Signs an Option Agreement with Senti Bio to Develop Precision Gene Therapies

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

Prestige Biopharma and Pharmapark Sign an Exclusive License and Supply Agreement to Commercialize HD204 (biosimilar, bevacizumab) in Russia

PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab

J&J Pauses Dosing of COVID-19 Vaccine Due to Blood Clotting

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Tags : Cystic Fibrosis (CF)

Vertex Pharmaceuticals’ Orkambi (lumacaftor+ivacaftor) Receives EU Approval for Cystic Fibrosis

Vertex’s Kalydeco (ivacaftor) Receives FDA’s Expanded Label Approval for Cystic

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ViewPoints Interview: ViiV Healthcare’s Dr. Kimberly Smith Shares Insight on the Data Presented at CROI 2021

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Evotec Signs a License Agreement with Kazia Therapeutics for Clinical Development of EVT801

Tags : Cystic Fibrosis (CF)

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