Clinical Intelligence

Soligenix completes phase I in SGX203 for pediatric Crohn’s

Wednesday, July 3, 2013 08:50 AM

Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, has enrolled and treated all patients in the phase I study BDP-PCD-01, a clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The SGX203 development program previously has received Fast Track and Orphan Drug designations from the FDA.

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The CenterWatch Monthly, July 2013

Monday, July 1, 2013 02:01 PM

CISCRP looks inside patients’ perceptions, motives

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CryoLife receives conditional IDE approval

Tuesday, June 25, 2013 03:45 PM

CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the FDA.

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Grunenthal expands use of BioClinica's Trident

Tuesday, June 25, 2013 12:43 PM

BioClinica, a global provider of clinical trial management solutions, has announced international research-based pharmaceutical Grunenthal will utilize enhancements in Trident IWR/IVR for a global study on pain medication. The three year study will involve 350 patients at 80 sites across 17 countries.

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TWi Biotechnology completes phase II trial patient enrollment

Monday, June 24, 2013 03:44 PM

TWi Biotechnology has completed patient enrollment in a phase II trial of AC-201 for Gout Flare Prophylaxis (GFP) during urate-lowering therapy (ULT). This randomized, double-blind, placebo-controlled phase II study is conducted in eight medical centers in Taiwan and includes patients with acute arthritis of primary gout and elevated serum uric acid. A total of 82 patients were randomized at a 1:1 ratio to receive 50mg AC-201 or placebo twice daily in addition to the ULT during the 16-week treatment period.

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International study on genetic causes of ALS

Monday, June 24, 2013 03:40 PM

The ALS Center in the Netherlands has started an international study into the genetic cause of the fatal disease amyotrophic lateral sclerosis (ALS), also known as motor neurone disease in the U.K. and Lou Gehrig’s disease in the U.S. Researchers in project MinE are collecting, examining and comparing as many DNA profiles as possible from ALS patients as well as from healthy volunteers. The study is being coordinated by the University Medical Center (UMC) Utrecht and is a step for an ALS treatment.

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Alimera Sciences receives positive appraisal consultation recommendation

Tuesday, June 18, 2013 01:10 AM

Alimera Sciences, a biopharmaceutical company that specializes in the R&D and commercialization of prescription ophthalmic pharmaceuticals, said the U.K.'s National Institute for Health and Care Excellence (NICE) Appraisal Committee has issued a positive Appraisal Consultation Document (ACD) on ILUVIEN for the treatment of pseudophakic patients with chronic diabetic macular edema (DME). The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme (PAS) that was submitted by Alimera for rapid review.

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Cempra outlines steps for regulatory approval of solithromycin

Monday, June 17, 2013 02:07 PM

Cempra, a clinical-stage pharmaceutical company developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, has described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia (CABP).  This path is a result of a dialogue and end-of-phase II meeting with the FDA.

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Northwest Biotherapeutics initiates phase I/II trial

Friday, June 14, 2013 01:38 PM

Northwest Biotherapeutics, a developer of non-toxic DCVax personalized immune therapies for solid tumor cancers, has announced  its 60-patient, phase I/II clinical trial of DCVax-Direct for all inoperable solid tumor cancers has been initiated at The University of Texas MD Anderson Cancer Center.

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Medicago receives Health Canada authorization for phase II trial

Friday, June 14, 2013 01:37 PM

Medicago, a biopharmaceutical company focused on developing vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), has received clearance by Health Canada to initiate its phase II, dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate. All clinical lots have been produced and the trial will commence with interim results expected this summer.

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