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NewLink Genetics, Merck receives Vaccine Industry Excellence Awards

Friday, April 17, 2015 01:09 PM

NewLink Genetics, a biopharmaceutical company focused on bringing novel immunotherapeutic medicines to cancer patients globally, and Merck received two Vaccine Industry Excellence (ViE) awards presented during the 15th Annual World Vaccine Congress. The ViE Awards honor the efforts, accomplishments and positive contributions of companies and individuals in the vaccine industry.

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Quest Diagnostics

Alliance for Multispecialty Research named 2015 Best Clinical Trial Network

Friday, April 17, 2015 01:05 PM

Presented at the World Vaccine Congress 2015 in Wash., D.C., the vaccine industry came to a consensus that the Alliance for Multispecialty Research had outperformed the competition in the trial network field. The Vaccine Industry Excellence (ViE) Award for Best Clinical Site/Network recognizes the efforts, accomplishments and positive contributions to the vaccine industry by a clinical research site/network.

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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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Merck chairman, CEO Kenneth C. Frazier becomes PhRMA board chairman

Friday, April 17, 2015 12:40 PM

Kenneth C. Frazier, chairman and CEO of Merck, was elected chairman of the board of the Wash. D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA). At the board meeting, PhRMA’s president and CEO John J. Castellani announced he will be retiring Jan. 1, 2016. 

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Incyte joins Safe-Biopharma Association

Friday, April 17, 2015 12:39 PM

Incyte, a Delaware-based biopharmaceutical company, has joined SAFE-BioPharma Association, a nonprofit industry coalition responsible for the ongoing development and implementation of the SAFE-BioPharma digital identity and signature standard.

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Precision for Medicine acquires Precision Health Economics

Friday, April 17, 2015 12:38 PM

Precision for Medicine, a Bethesda, Md.- based specialized services company supporting next-generation approaches to drug development and commercialization, has acquired Precision Health Economics (PHE), a health economics consultancy and analytics firm. PHE leverages the experience of policy analysts, economists, clinicians and academics to advance research on the most complex healthcare questions. Life sciences companies and policymakers worldwide turn to PHE to shape strategy, inform key healthcare decisions, and produce effective changes in policy through innovative research.

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INC Research establishes site advocacy group for clinical trial management

Friday, April 17, 2015 12:37 PM

INC Research, a global CRO, has formed a new Site Advocacy Group (SAG) focused on streamlining and enhancing the payment process for clinical research sites. Through this forum, INC Research will work with sites to improve a key aspect of clinical trial management and facilitate ongoing dialogue on operational best practices for conducting successful research.

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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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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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CWWeekly

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

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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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The CenterWatch Monthly

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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