Clinical Intelligence

The CenterWatch Monthly, May 2015

Friday, May 1, 2015 08:00 AM

Job satisfaction mixed as workload increases

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Quest Diagnostics

PTC Therapeutics' cancer stem cell program targeting BMI1 enters phase I

Thursday, April 30, 2015 11:45 AM

PTC Therapeutics has announced that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a phase I study in patients with advanced solid tumors. The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC's BMI1 program is supported by a collaboration with the Wellcome Trust.

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Benitec Biopharma doses fifth patient, initiates additional trial site for hepatitis C trial

Thursday, April 30, 2015 11:41 AM

Benitec Biopharma, a Sydney, Australia-based biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or "expressed RNAi,” has doesed the fifth patient in the company's first-in-man, phase I/IIa dose escalation clinical trial of TT-034 for hepatitis C virus (HCV) infection at the Duke Clinical Research Unit. The fifth patient is the third and final patient to be dosed in cohort two.

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FDA approves first generic Abilify to treat mental illnesses

Thursday, April 30, 2015 11:07 AM

Alembic Pharmaceuticals, Hetero LabsTeva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic Abilify (aripiprazole) in multiple strengths and dosage forms. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. 

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DanDrit Biotech USA, GISCAD Foundation form final collaboration agreement

Wednesday, April 29, 2015 12:08 PM

DanDrit Biotech USA, a biotechnology company developing a vaccine for the treatment of colorectal cancer, has signed a final collaboration agreement with GISCAD Foundation, an Italian group focused on digestive tract cancer studies.

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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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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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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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The CenterWatch Monthly

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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