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Immunocore, MedImmune collaborate on immuno-oncology combination trials

Friday, April 17, 2015 12:36 PM

Immunocore, a biotechnology company developing novel biological drugs to treat cancer and other diseases headquartered outside Oxford, England, and MedImmune, the global biologics R&D arm of AstraZeneca, have entered into a second collaboration.

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Quest Diagnostics

Takeda appoints new president of U.S. business unit

Thursday, April 16, 2015 03:11 PM

Takeda Pharmaceutical has appointed Ramona Sequeira as president of the U.S. business unit. In this role, Sequeira will lead all business operations for the U.S., and will report to Christophe Weber, the president and CEO of Takeda.

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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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Aptuit, Axxam collaborate on integrated drug discovery services

Thursday, April 16, 2015 12:47 PM

Aptuit, a CRO based in Greenwich, Conn., and Axxam, a Milan, Italy-based discovery company with experience in target biology and a broad range of early phase discovery solutions, have announced a strategic alliance to provide comprehensive and integrated services from gene to high-quality candidates and beyond.

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TransCelerate BioPharma launches two initiatives to improve clinical research

Thursday, April 16, 2015 12:46 PM

TransCelerate BioPharma, a nonprofit organization dedicated to improving the health of people around the world by accelerating and enhancing the R&D of innovative new therapies, has established two new global initiatives which will accelerate and enhance clinical trials. Both initiatives, Placebo/Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels), aim to create solutions that will have a direct impact on patients, sponsors and investigative sites.

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Quintiles names Hospital Italiano first Latin American Prime Site

Thursday, April 16, 2015 12:45 PM

Global CRO Quintiles has named Hospital Italiano of Buenos Aires, Argentina, as its first Prime Site in Latin America.

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Iris Pharma, Oculos Clinical Research ink ophthalmic agreement

Thursday, April 16, 2015 12:43 PM

Iris Pharma, a France-based, ophthalmology-focused CRO that offers preclinical and clinical drug/device development services, and Oculos Clinical Research, a Tampa, Fla.-based full-service CRO specializing in ophthalmology, have formed a strategic alliance.

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ERT launches Insights Cloud

Thursday, April 16, 2015 12:41 PM

ERT, a global solutions provider for patient safety and efficacy endpoint data collection headquartered in Philadelphia, Pa., has launched Insights Cloud, a suite of data analytics, visualization and workflow applications that leverage real-time clinical trials data to provide clinical trial sponsors and CROs with actionable insights and process optimization.

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Medidata, Peking University expand partnership in China

Wednesday, April 15, 2015 12:55 PM

Medidata, a global provider of cloud-based solutions for clinical research in life sciences, has expanded its partnership with Peking University Clinical Research Institute (PUCRI), an academic center dedicated to enhancing the development of high-quality clinical research and health innovation in China. Leveraging the research institute’s extensive clinical development network, experience and resources, the partnership will accelerate the adoption of the Medidata Clinical Cloud platform across China and, in doing so, optimize local drug development programs by bringing operational efficiencies and greater speed to clinical trials.

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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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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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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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