clinical trials

May 27, 2019May 27, 2019

Agency Unveils RaDaR to Help Patient Groups Develop Rare Disease Registries

News

RaDaR, the catchy new name for the U.S. government-run Rare Diseases Registry Program, aims to help patient advocacy groups with limited resources build their own disease registries. The site was ... Read more

December 13, 2018December 13, 2018

Zambon’s Inhalable Antibiotic for Non-CF Bronchiectasis Gets Fast Track, QIDP Status from FDA

News

The U.S. Food and Drug Administration (FDA) granted Qualified Infectious Diseases Product (QIDP) and Fast Track designations to Zambon’s inhalable colistimethate sodium product to help prevent non-cystic fibrosis bronchiectasis (NCFBE) ... Read more

October 18, 2018October 18, 2018

Incremental Shuttle Walk Test a Reliable Measure of Bronchiectasis Therapy Response, Study Suggests

News

Improvements in physical ability as seen with the incremental shuttle walk test (ISWT) mirror pulmonary function improvements in bronchiectasis patients, a study reports, indicating that the test could serve as a ... Read more

March 12, 2018March 12, 2018

Rare Disease Groups Welcome FDA’s Embrace of ‘Real World’ Data in Clinical Trials

News

In his 10 months on the job, Commissioner Scott Gottlieb of the U.S. Food and Drug Administration is earning praise for his efforts to make clinical trials for new therapies ... Read more

February 15, 2018February 15, 2018

Stem Cell Transplants Rejuvenate Chinese Bronchiectasis Patients’ Damaged Lungs

News

Chinese medical scientists used stem cell transplants to rejuvenate the damaged lungs of two bronchiectasis patients, a study reports. An article on the pilot clinical trial’s results appeared in the journal ... Read more

January 16, 2018January 16, 2018

FDA Advisory Committee Not Convinced of Linhaliq’s Benefits in Bronchiectasis Infections

News

An advisory committee is recommending against U.S. regulatory approval of a mist formulation that Aradigm developed to deliver an antibiotic for the Pseudomonas aeruginosa lung infections in bronchiectasis. Although the U.S. Food and Drug ... Read more

January 4, 2018January 4, 2018

FDA Panel Opposes Approving Cipro DPI to Treat Non-CF Bronchiectasis

News

A U.S. Food and Drug Administration (FDA) advisory panel voted not to recommend ciprofloxacin dry powder for inhalation (Cipro DPI), being developed by Bayer, to be approved for the treatment ... Read more

November 7, 2017November 7, 2017

Pilot Study to Test Nitric Oxide Gas Treatment on Nontuberculous Mycobacteria Infections

News

A small, pilot Phase 1/2 clinical trial evaluating the safety and efficacy of Thiolanox inhaled nitric oxide gas in treating nontuberculous mycobacteria (NTM) infection has been approved by Health Canada. ... Read more

July 28, 2017July 28, 2017

New Drug Application Submitted for Linhaliq as Treatment of Pseudomonas Aeruginosa Infection in NCFBE Patients

News

The pharmaceutical company Aradigm has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Linhaliq (ciprofloxacin) as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) in patients with chronic lung ... Read more