Clinical Intelligence

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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Quest Diagnostics

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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Clinical trials prove Canada's VSV-EBOV Ebola vaccine safe and effective

Thursday, April 2, 2015 02:46 PM

Canada's VSV-EBOV Ebola vaccine proved to be safe and effective in a phase I clinical trial, according to findings published in the New England Journal of Medicine. These studies were performed at the Walter Reed Army Institute of Research and the National Institute of Allergy and Infectious Diseases to explore the experimental vaccine's safety and what immune response it evokes when administered at different dosages.

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Enzalutamide, bicalutamide demonstrate positive results in Strive trial

Thursday, April 2, 2015 01:38 PM

Astellas Pharma and Medivation has announced topline results from the phase II STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer. The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001). Median PFS was 19.4 months in the enzalutamide group compared with 5.7 months in the bicalutamide group.

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The CenterWatch Monthly, April 2015

Wednesday, April 1, 2015 08:42 AM

PSI, INC Research, Chiltern best with sites

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Parkinson's Biomarker Initiative expands genetic study

Friday, March 27, 2015 01:26 PM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with a mutation of the GBA (glucosidase beta acid) gene. Participants will include people with or at increased risk to develop Parkinson's disease. Researchers hope that a greater understanding of the biology and clinical features of these participants will lead to therapies benefiting all Parkinson's patients and ultimately provide strategies to prevent disease onset.

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Mast to develop Vepoloxamer (MST-188) in chronic heart failure

Friday, March 27, 2015 01:15 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the company expects to begin dosing in a phase II study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.

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CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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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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