In April 2004, the Food and Drug Administration (FDA) issued a new rule requiring makers of pancreatic enzyme products (PEPs) to get their drugs approved by April 28, 2010. Unapproved pancreatic enzyme products had been available for many years, but after that cut-off date, makers of pancreatic enzyme products were required…
News
Xenetic Biosciences recently announced that the drug developer’s Phase I clinical trial of its new cystic fibrosis treatment PulmoXen has yielded positive results in the treatment of the disease. The announcement comes as promising news for the 30,000 patients with CF who live in the United States, and who remain…
A major drug developer is switching gears from Hepatitis C to Cystic Fibrosis, as Vertex’s new Proof-of-Concept Study Finds VX-661 And Kalydeco (ivacaftor) CF Drug Combination Improves Lung Function in Some Patients. For those in the cystic fibrosis patient population who follow research news for hints of the next major pharmaceutical development,…
While Cystic Fibrosis news is never in short supply, often times, many clinical trials currently underway to test experimental CF therapies are underreported by the media, who instead seek to cover fundraising and human interest stories about the disease. While these types of news articles are indeed important to…
Vertex Pharmaceuticals continues to break new ground on developing treatments for the orphan disease cystic fibrosis. Most recently, Vertex received the FDA’s Orphan Drug Designation for its investigational drug VX-661. Orphan drug designation was established in January 1983 as a result of the Orphan Drug Act in order to encourage…
Last Saturday, April 26th, a team of hikers called Team FiltersFast.com, along with team leader and company President Ray Scardigno, took part in the Cystic Fibrosis Xtreme Hike for a Cure where they had to trek more than 30 miles in a single day along the popular Appalachian Trail. Over the last…
Two types of bacteria have been associated with cystic fibrosis (CF): Burkholderia cenocepacia and Burkholderia multivorans. The two species have been found to be quite similar, in that they are both contagious, multi-drug resistant, and have an affinity for affecting immunocompromised individuals, or those diagnosed with CF. A group of…
An antimicrobial peptide produced by human immune cells may actually promote bacterial survival in cystic fibrosis patients with a chronic lung infection of Pseudomonas aeruginosa and lead to respiratory failure. The discovery was made by Daniel Wozniak and colleagues from Ohio State University Wexner Medical Center, who published a…
According to a recent press release, the respiratory drug developer Opko Health has acquired Inspiro Media Ltd., which has developed a “smart,” easy-to-use powder digital inhaler to deliver small molecule drugs such as corticosteroids for respiratory diseases such as cystic fibrosis. This new platform will give the company several…
The Cystic Fibrosis Foundation describes CF as a genetically-acquired chronic disease that impacts the lungs and gastrointestinal tract, causing these body systems to produce abnormally thick, and viscid mucus that has the tendency to consolidate in the lungs and block the secretion of pancreatic enzymes, resulting in malabsorption. Today,…
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