BEF, Author at The Boomer Esiason Foundation

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...

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...

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...

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...

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...

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,...

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...

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...

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...

Author: BEF

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

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

FDA Requests Additional Study of Arikace®, Insmed Says

Pulmatrix Invests in Clinical Programs in Cystic Fibrosis and COPD

Insmed Announces Clinical Hold on ARIKACE® Phase 3 Clinical Trials

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

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

FDA Approves Infant Dosage for CREON

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

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

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