Clinical Intelligence

Mitotech releases positive phase II data of SkQ1 for dry eye

Friday, April 24, 2015 02:11 PM

Mitotech, a Luxembourg-based clinical-stage biotechnology company developing novel antioxidant molecules targeting mitochondria, has achieved significant positive results in its U.S. phase II clinical trial of SkQ1 compound in patients with moderate to severe dry eye syndrome. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria, which proved to be effective in a topical ophthalmic formulation for treatment of dry eye syndrome.

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Quest Diagnostics

Biohaven to begin phase I study in 3Q2015, readying for phase III study start by 1Q2016

Friday, April 24, 2015 01:58 PM

Biohaven Pharmaceutical Holding is on schedule to initiate a phase I pharmacokinetic and biomarker study with its lead drug development candidate BHV-0223. Biohaven plans to initiate the trial no later than 3Q2015. After confirming projected drug exposure levels in the phase I study, Biohaven will move directly into a phase III registrational trial in affective disorders.

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Ebola vaccine trial begins in Sierra Leone

Thursday, April 23, 2015 03:08 PM

The Centers for Disease Control and Prevention (CDC), in partnership with the Sierra Leone College of Medicine and Allied Health Sciences (COMAHS) and the Sierra Leone Ministry of Health and Sanitation (MoHS), now is enrolling and vaccinating volunteers for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). This study will assess the safety and efficacy of the rVSV-ZEBOV candidate Ebola vaccine among health and other frontline workers.

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ALS Association, Harvard, Massachusetts General collaborate with GSK

Friday, April 17, 2015 12:56 PM

The ALS AssociationHarvard Stem Cell Institute and Massachusetts General Hospital Neurological Clinical Research Institute are collaborating with GlaxoSmithKline on a clinical trial to evaluate the potential of an anti-epileptic drug in ALS patients. In parallel testing, brain cells will be made from each patient's stem cells to see if they can predict which patients might respond to the medicine.

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Reata Pharmaceuticals receives Orphan Drug Designation for Bardoxolone Methyl

Thursday, April 16, 2015 02:42 PM

The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for Reata Pharmaceuticals’ bardoxolone methyl for the treatment of pulmonary arterial hypertension (PAH). PAH is a life-threatening disease involving endothelial dysfunction, pulmonary vasoconstriction, vascular remodeling, pulmonary fibrosis and right ventricular hypertrophy. Additionally, PAH involves skeletal muscle dysfunction that contributes to the exercise intolerance observed in PAH patients. In preclinical studies, bardoxolone methyl has demonstrated potent antioxidant, anti-inflammatory, and bioenergetic properties, which may lead to improved exercise tolerance in patients.

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FDA modifies partial clinical hold on Tekmira's TKM-Ebola IND

Thursday, April 16, 2015 02:33 PM

The FDA has notified Tekmira Pharmaceuticals, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV) headquartered in Vancouver, BC, Canada, that the partial clinical hold on the company's Investigational New Drug application (IND) for TKM-Ebola has been modified to permit repeat dosing of healthy volunteers at a dose of 0.24mg/kg/day. The IND remains on partial clinical hold with regard to doses above 0.24mg/kg/day in healthy volunteers.

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FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Thursday, April 9, 2015 02:20 PM

The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.

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Rhythm initiates phase IIb clinical trial of relamorelin for diabetic gastroparesis

Thursday, April 9, 2015 12:59 PM

Rhythm, a biopharmaceutical company, and Actavis, a global pharmaceutical company, have initiated a phase IIb clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Pharmaceuticals, upon the completion of the phase IIb study.

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Celtaxsys to begin phase II trial of oral CTX-4430 for acne vulgaris

Thursday, April 9, 2015 12:48 PM

Atlanta-based pharmaceutical company Celtaxsys has received regulatory clearance to commence a phase II trial for its flagship compound, CTX-4430, in patients with moderate to severe facial acne vulgaris. This approval triggers site engagement to screen and enroll appropriate patients with acne.

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Oramed enrolls first patient in glucose clamp study for oral insulin

Friday, April 3, 2015 10:22 AM

Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has enrolled the first patient in its glucose clamp study. The study will be performed at the University of Texas Health Science Center at San Antonio and University Health System's Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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