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Covance, Sihuan partner in preclinical and clinical portfolio development

Thursday, April 2, 2015 12:56 PM

LabCorp, a North Carolina-based healthcare diagnostics company, and Shandong XuanZhu Pharma, the wholly-owned subsidiary for innovative drug R&D of Sihuan Pharmaceutical, have inked a long-term partnership with Covance Drug Development (part of LabCorp) to support the global development of Sihuan’s drug candidate pipeline.

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Quest Diagnostics

Horizon Pharma to acquire Hyperion Therapeutics for $1.1B in cash

Wednesday, April 1, 2015 01:59 PM

Horizon Pharma, based in Ireland, will acquire all of the issued and outstanding shares of California-based Hyperion Therapeutics’ common stock for $46 per share in cash, or approximately $1.1 billion on a fully diluted basis.

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NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015 01:08 PM

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

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Teva to acquire Auspex for $3.5 billion

Wednesday, April 1, 2015 01:04 PM

Teva Pharmaceutical Industries, headquartered in Israel, and Auspex Pharmaceuticals, based in California, have agreed to merge. Teva will commence a tender offer for all of the outstanding shares of Auspex at $101 per share in cash, for a total of approximately $3.2 billion in enterprise value and approximately $3.5 billion in equity value.

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PRA Health Sciences expands global phase I patient strategy

Wednesday, April 1, 2015 01:03 PM

PRA Health Sciences, a global CRO headquartered in Raleigh, N.C., is enhancing its global phase I patient strategy and increasing its clinical footprint with the expansion of its early development services (EDS). These initiatives are being undertaken in response to market demand to include patients as early as possible in early phase clinical trial development and include:

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Broad Institute, Bayer Healthcare expand partnership

Wednesday, April 1, 2015 01:01 PM

The Broad Institute of MIT and Harvard has expanded its collaboration with Bayer HealthCare to include cardiovascular genomics and drug discovery. The goal of this new part of the alliance is to leverage insights from human genetics to help create new cardiovascular therapies.

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Fujifilm to acquire Cellular Dynamics International

Wednesday, April 1, 2015 01:00 PM

Fujifilm, a multinational photography and imaging company headquartered in Tokyo, has entered into a definitive agreement to acquire Cellular Dynamics International (CDI), a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, via an all-cash tender offer to be followed by a second step merger.

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BARDA awards $35M contract to BioCryst’s BCX4430

Wednesday, April 1, 2015 12:58 PM

The Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded Durham, N.C.-headquartered BioCryst Pharmaceuticals a contract for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses.

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Quintiles, Quest Diagnostics to form joint venture to provide global trial lab services

Wednesday, April 1, 2015 12:57 PM

Quintiles and Quest Diagnostics, a Madison, N.J.-based provider of diagnostic information services, have agreed to form a global clinical trials laboratory services business. The new entity will provide customers with a depth of capabilities and end-to-end clinical trial lab services.

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Syndax, Merck to collaborate on immuno-oncology study

Wednesday, April 1, 2015 12:54 PM

Syndax Pharmaceuticals, based in Waltham, Mass., and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Syndax’s entinostat, an investigational epigenetic therapy, with Merck’s Keytruda (pembrolizumab), the first anti-PD-1 therapy approved in the U.S. The phase Ib/II study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The study is expected to begin enrolling patients in the second half of 2015.

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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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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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