Clinical Intelligence

FDA Fast Track designations reach 20th year

Monday, October 2, 2017

Mixed experience but no changes in the forecast

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.

[Read More]

Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

[Read More]

Sound Pharmaceuticals initiates STOP Ototoxicity study in cystic fibrosis

Wednesday, September 27, 2017

Sound Pharmaceuticals (SPI) has initiated enrollment on its first study involving Cystic Fibrosis (CF) patients receiving antibiotics that cause inner ear disease or ototoxicity. The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston. Dr. Flume is an international expert in CF and pulmonary disease and has co-chaired the development of the CF Foundation’s care guidelines on the treatment of pulmonary exacerbations. “We recently explored the incidence of tinnitus and vertigo in the CF population, and will present these initial findings at the next North American CF Conference,” said Dr. Flume.

[Read More]

W. L. Gore & Associates completes enrollment in GORE CARDIOFORM study

Wednesday, September 27, 2017

W. L. Gore & Associates has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE® CARDIOFORM ASD Occluder is designed with a unique, anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury. This new device will complement the existing GORE® CARDIOFORM Septal Occluder to allow the treatment of a broader range of ASDs with a soft, conformable device design.

[Read More]

Recipharm and Clinical Trial Consultants partner to streamline clinical trials

Monday, September 25, 2017

Recipharm, a contract development and manufacturing organization (CDMO), recently announced its new partnership with Swedish CRO Clinical Trial Consultants (CTC) for the development of a comprehensive list of services for first-in-human clinical trials. The partnership’s project, titled Recipharm Pathway to Clinic, is geared toward streamlining clinical trials and facilitating research from the early phase of formulation development to trial implementation.

[Read More]

FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis

Monday, September 18, 2017

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

[Read More]