Emma Mueller, Author at The Boomer Esiason Foundation

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 Emma Mueller

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...

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

by Emma Mueller

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...

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

by Emma Mueller

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 Emma Mueller

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 Emma Mueller

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 Emma Mueller

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 Emma Mueller

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 Emma Mueller

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 Emma Mueller

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...

Author: Emma Mueller

FDA Grants Priority Review for KALYDECO™ from Vertex Pharmaceuticals

How CF-Related Diabetes Differs from Types 1 and 2

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

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