Emma Mueller, Author at The Boomer Esiason Foundation

March 19, 2019

Digestive Care, Inc. (DCI), announced it has received U.S. Food and Drug Administration (FDA) approval of its new drug application for PERTZYE™, indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. PERTZYE is a unique pancreatic enzyme product containing bicarbonate-buffered...

Vertex Reports Promising Interim Results for Phase 2 Trial of Kalydeco and VX-809

by Emma Mueller

CF News, Therapies

March 19, 2019

Source: Cystic Fibrosis Foundation Vertex Pharmaceuticals Inc. today announced promising interim results from a Phase 2 clinical trial of its cystic fibrosis drug Kalydeco™ and VX-809, a CF drug in development. The results showed a significant improvement in lung function in people with two copies of the...

PMD Healthcare Giving Away Spiro PDs for World Asthma Day

by Emma Mueller

CF Community, CF News, Therapies

March 19, 2019

PMD Healthcare is encouraging the cystic fibrosis community to enter its sweepstakes contest for a chance to win a Spiro PD -- a personal spirometer. The contest is being held to mark World Asthma Day on May 2. But since Spiro PDs are meant for patients...

FDA Approves New Enzyme Therapy for People with CF

by Emma Mueller

CF News, Therapies

March 19, 2019

Source: FDA news release Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved March 1 by the U.S. Food and Drug Administration. Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious...

Gilead Sciences Working to Address Supply Shortage of Cayston

by Emma Mueller

CF News, Therapies

March 19, 2019

Source: Gilead website February 15, 2012 Important Information Regarding the Availability of Cayston® To the CF Community, Gilead Sciences, Inc., the manufacturer of Cayston, is facing significant and unanticipated challenges manufacturing enough Cayston to meet demand in the United States. Gilead is committed to patient care. To that end, we...

PMD Healthcare Launches Personal Spirometer To Monitor Lung Function

by Emma Mueller

CF News, Therapies

March 19, 2019

Source: PMD Healthcare press release PMD Healthcare Inc., announced today the launch and availability of its novel new lung health monitoring device – Spiro PD. Recently cleared by the U.S. Food and Drug Administration (FDA), Spiro PD is the first and only personal spirometer that enables...

FDA Approves KALYDECO™; Vertex to Begin Shipments Immediately

by Emma Mueller

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 approved KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO (kuh-LYE-deh-koh) is approved for people with CF ages...

Vertex Planning Additional KALYDECO™ Clinical Trials in 2012

by Emma Mueller

CF News, Therapies

March 19, 2019

Souce: Vertex Pharmaceuticals press release Vertex Pharmaceuticals says it plans to begin additional studies of KALYDECO™ in children with cystic fibrosis as young as two years of age and in people with CF who have certain mutations that were not evaluated in the previous Phase 3...

Kalydeco (VX-770) Available to People with Critical Medical Need

by Emma Mueller

CF News, Therapies

March 19, 2019

Source: Cystic Fibrosis Foundation An expanded access program for a potential new CF drug, Kalydeco™ (VX-770), is now available at participating clinical sites throughout the country for people with the G551D mutation who have highly limited lung function and may benefit from treatment. Vertex Pharmaceuticals, Inc., the...

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

by Emma Mueller

CF News, 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...

Author: Emma Mueller

FDA Approves New Drug Application for Digestive Care’s PERTZYE

Vertex Reports Promising Interim Results for Phase 2 Trial of Kalydeco and VX-809

PMD Healthcare Giving Away Spiro PDs for World Asthma Day

FDA Approves New Enzyme Therapy for People with CF

Gilead Sciences Working to Address Supply Shortage of Cayston

PMD Healthcare Launches Personal Spirometer To Monitor Lung Function

FDA Approves KALYDECO™; Vertex to Begin Shipments Immediately

Vertex Planning Additional KALYDECO™ Clinical Trials in 2012

Kalydeco (VX-770) Available to People with Critical Medical Need

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

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