Therapies

March 19, 2019

Source: American Thoracic Society press release Adding inhaled dry powder mannitol to standard therapy for cystic fibrosis produced sustained improvement in lung function for up to 52 weeks, according to a new study. Along with the treatment's efficacy and good safety profile, the convenience and ease...

FDA Grants Priority Review for KALYDECO™ from Vertex Pharmaceuticals

by BEF

CF News, Therapies

March 19, 2019

Source: Vertex Pharmaceuticals press release Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECO™ (ivacaftor) and granted the company's request for six-month priority review. KALYDECO targets the defective protein that causes cystic fibrosis (CF)...

How CF-Related Diabetes Differs from Types 1 and 2

by BEF

CF News, Therapies

March 19, 2019

Source: Diabetic Live In addition to Type 1 and Type 2 diabetes, there is another variant of the disease: cystic fibrosis-related diabetes. It differs in some important ways from Type 1 and Type 2 diabetes and it requires different treatment methods. Patients with cystic fibrosis experience decreased...

Vertex Applies to FDA for Priority Review, Approval of VX-770

by BEF

CF News, Therapies

March 19, 2019

Vertex Pharmaceuticals Inc. today announced the submission of a new drug application to the U.S. Food and Drug Administration for KALYDECO™ (VX-770, ivacaftor), a medicine in development that targets the defective protein that causes cystic fibrosis. KALYDECO (kuh-LYE-deh-koh) was studied among people with CF ages six...

New England Journal of Medicine Features Study of Kalydeco (VX-770)

by BEF

CF News, Therapies

March 19, 2019

Source: Cystic Fibrosis Foundation The New England Journal of Medicine, the world’s most widely read and influential medical periodical, features a study this week about a Phase 3 clinical trial of Kalydeco™ (VX-770), a potential CF therapy undergoing review for approval by the U.S. Food and...

FDA Requests Additional Study of Arikace®, Insmed Says

by BEF

CF News, Therapies

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...

Pulmatrix Invests in Clinical Programs in Cystic Fibrosis and COPD

by BEF

CF News, Therapies

March 19, 2019

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced that its clinical development plans will focus on the company’s lead clinical candidate in chronic obstructive pulmonary disease (COPD) and cystic...

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 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,...

Therapies

Mannitol Shown to Improve Lung Function When Added to Standard CF Therapy

FDA Grants Priority Review for KALYDECO™ from Vertex Pharmaceuticals

How CF-Related Diabetes Differs from Types 1 and 2

Vertex Applies to FDA for Priority Review, Approval of VX-770

New England Journal of Medicine Features Study of Kalydeco (VX-770)

FDA Requests Additional Study of Arikace®, Insmed Says

Pulmatrix Invests in Clinical Programs in Cystic Fibrosis and COPD

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 25,000 Lipase-Unit Strength of ZENPEP®

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