Clinical Intelligence

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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WIRB Copernicus Group

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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CTI Clinical Trial and Consulting Services, Galectin Therapeutics collaborate

Thursday, June 13, 2013 02:03 PM

CTI Clinical Trial and Consulting Services (CTI), an international drug and device development organization, will collaborate with Galectin Therapeutics on a first-in-man phase I clinical trial  of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis.

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Abbott initiates trial to evaluate Absorb BVS

Thursday, June 13, 2013 12:00 PM

Abbott has announced the initiation of the Absorb Japan randomized, controlled clinical trial to evaluate the Absorb Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease. The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan.

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Viatronix V3D-Colon software used in trial

Wednesday, June 12, 2013 02:44 PM

Viatronix, a maker of non-invasive 2D/3D medical imaging and diagnostic software, said its dedicated CT Colonography (CTC) software, V3D-Colon, was exclusively used in a clinical study relating to colorectal cancer screening. The latest CTC study tracked polyp growth in 243 patients over an eight-year period.

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BioAlliance Pharma initiates phase II trial of Validive

Tuesday, June 11, 2013 04:04 PM

BioAlliance Pharma, a developer of orphan oncology products and supportive care products, initiated its phase II clinical trial evaluating the efficacy and safety of Validive (clonidine Lauriad) in the U.S. in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer.

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BDSI to file NDA for Bunavail

Monday, June 10, 2013 11:49 AM

BioDelivery Sciences International (BDSI) had a positive pre-New Drug Application (NDA) meeting with the FDA regarding Bunavail for the maintenance treatment of opioid dependence.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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