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AbbVie, C2N ink agreement for Alzheimer's disease therapy

Friday, March 20, 2015 02:06 PM

AbbVie has entered into an exclusive worldwide license agreement with C2N Diagnostics, a privately held protein diagnostic and therapeutic discovery company based in Saint Louis, Mo., to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer's disease and other neurological disorders. This partnership builds upon AbbVie's commitment to pursue transformational disease-modifying therapies in Alzheimer's disease.

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Quest Diagnostics

Coronado Biosciences, City of Hope form Mustang Therapeutics

Friday, March 20, 2015 02:03 PM

Coronado Biosciences has formed a new company, Mustang Therapeutics, in partnership with California research and treatment center City of Hope. Mustang initially will focus on the preclinical and clinical development, as well as commercialization of proprietary Chimeric Antigen Receptor (CAR-T) technology. The deal is valued in excess of $40 million for the development of these CAR-T cells via up-front and milestone payments to City of Hope. It is anticipated the first two CAR-T cells from this partnership will begin enrollment in human clinical trials at the City of Hope this year.

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Broad Institute, Calico collaborate on aging

Friday, March 20, 2015 01:56 PM

The Broad Institute of MIT and Harvard has entered into a partnership with Calico around the biology and genetics of aging and early-stage drug discovery. The partnership will support several efforts at the Broad Institute to advance the understanding of age-related diseases and to propel the translation of these findings into new therapeutics.

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Catalent launches Quality, Product Development & Regulatory Affairs organization

Thursday, March 19, 2015 02:55 PM

Catalent Pharma Solutions, a Somerset, N.J.-based global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has formed the Quality, Product Development & Regulatory Affairs organization, established to build upon Catalent’s experience in new product development, regulatory excellence, reliable supply and quality. Sharon Johnson, senior vice president, global quality & regulatory affairs, will head up Catalent’s new organization.

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Clinical Ink merges with CentrosHealth

Thursday, March 19, 2015 02:53 PM

Clinical Ink, a provider of eSource solutions for clinical trials with offices in Philadelphia, Pa., and Winston-Salem, N.C., has merged with CentrosHealth, a Boston-based provider of configurable mobile apps for clinical trial patient engagement and electronic patient reported outcomes (ePRO), founded by MPM Capital.

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Parkinson's Disease Foundation expands scientific leadership

Thursday, March 19, 2015 01:31 PM

The Parkinson's Disease Foundation (PDF) has expanded its scientific advisory board to guide the organization toward its goals of solving, treating and ending Parkinson's disease.

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Moderna appoints Tal Zaks as chief medical officer

Thursday, March 19, 2015 01:22 PM

Moderna Therapeutics, a developer of messenger RNA (mRNA) Therapeutics across a range of therapeutic applications, has announced that Tal Zaks, M.D., Ph.D., will join Moderna's executive leadership team as chief medical officer.

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Camargo Pharmaceutical names Jason Moore VP global program management

Thursday, March 19, 2015 01:17 PM

Camargo Pharmaceutical Services, a global strategist in the drug development industry specializing in the 505(b)(2) approval pathway, has appointed Jason Moore as vice president of global program management.

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Selten Pharma receives FDA Orphan Drug designation for PAH

Thursday, March 19, 2015 01:13 PM

Selten Pharma, a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, has announced its lead compound tacrolimus (SPI-026) has been granted Orphan Drug designation by the FDA for the treatment of pulmonary arterial hypertension (PAH).

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Can-Fite completes commercial biomarker test to predict patients' drug response

Thursday, March 19, 2015 01:09 PM

Can-Fite BioPharma, a Israel-based biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which currently are in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

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March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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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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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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