CF News

March 19, 2019

Insmed Inc., a biopharmaceutical company, today announced that it has been notified by the U.S. Food and Drug Administration that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis patients with...

Vertex Plans to Submit New Drug Application for VX-770 to FDA in October

by BEF

CF News, Therapies

March 19, 2019

Vertex Pharmaceuticals Inc. today announced it plans to submit to the U.S. Food and Drug Administration in October a new drug application for VX-770, a promising CF therapy. Following is information on the announcement from Vertex and the Cystic Fibrosis Foundation. FROM THE CYSTIC FIBROSIS FOUNDATION...

Insmed Announces Clinical Hold on ARIKACE® Phase 3 Clinical Trials

by BEF

CF News, Therapies

March 19, 2019

Insmed Inc., a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has notified the company that the agency has placed a clinical hold on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis (CF) patients with Pseudomonas...

FDA Approves Infant Dosage for CREON

by BEF

CF News, Therapies

March 19, 2019

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis. The CREON 3,000 units of lipase capsule provides the lowest dosage strength in the...

FDA Approves 25,000 Lipase-Unit Strength of ZENPEP®

by BEF

CF News, Therapies

March 19, 2019

Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), today announced that the U.S. Food and Drug Administration (FDA) has approved a new strength of ZENPEP® (pancrelipase) Delayed-Release Capsules. The new formulation will be offered in 25,000 units of lipase,...

Phase 2 Study of VX-770 and VX-809 Show Promising Results in Patients with Most Common Mutation

by BEF

CF News, Therapies

March 19, 2019

Vertex Pharmaceuticals Incorporated and the Cystic Fibrosis Foundation today announced promising results from an ongoing Phase 2 study evaluating combinations of VX-770 and VX-809, potential medicines designed to treat the defective protein that causes cystic fibrosis. The study enrolled 62 people with two copies of the...

VX-770 Shows Positive and Lasting Results Throughout 48-Week Phase 3 Study

by BEF

CF News, Therapies

March 19, 2019

Vertex Pharmaceuticals Inc. today announced final results of a Phase 3 clinical trial of VX-770, a CF medicine in development that targets the underlying cause of the disease. Participants who took the drug had rapid and significant improvements in lung function and other key measures...

Vertex to Expand Access to VX-770 for Patients with Critical Medical Need

by BEF

CF Community, CF News, Therapies

March 19, 2019

Vertex Pharmaceuticals Inc. announced a plan to provide VX-770, a CF medicine in development, to people with the G551D mutation who are in critical medical need and may benefit from treatment prior to potential approval of the drug from the U.S. Food and Drug Administration...

Drug Shortages Force Hospitals to Hunt for Substitutes

by BEF

CF Community, CF News, Therapies

March 19, 2019

A growing shortage of medications for a host of illnesses — from cancer to cystic fibrosis to cardiac arrest — has hospitals scrambling for substitutes to avoid patient harm, and sometimes even delaying treatment. "It's just a matter of time now before we call for a...

Aradigm Gets FDA Orphan Drug Designation for Ciprofloxacin for Inhalation in Bronchiectasis

by BEF

CF News, Therapies

March 19, 2019

Aradigm Corporation today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for ciprofloxacin for inhalation for the management of bronchiectasis (BE). Previously, Aradigm received orphan drug designations from FDA for liposomal ciprofloxacin for inhalation for the management of bronchiectasis...

CF News

FDA Requests Additional Study of Arikace®, Insmed Says

Vertex Plans to Submit New Drug Application for VX-770 to FDA in October

Insmed Announces Clinical Hold on ARIKACE® Phase 3 Clinical Trials

FDA Approves Infant Dosage for CREON

FDA Approves 25,000 Lipase-Unit Strength of ZENPEP®

Phase 2 Study of VX-770 and VX-809 Show Promising Results in Patients with Most Common Mutation

VX-770 Shows Positive and Lasting Results Throughout 48-Week Phase 3 Study

Vertex to Expand Access to VX-770 for Patients with Critical Medical Need

Drug Shortages Force Hospitals to Hunt for Substitutes

Aradigm Gets FDA Orphan Drug Designation for Ciprofloxacin for Inhalation in Bronchiectasis

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