Theorem Clinical Research

United States

Glialogix, National Multiple Sclerosis Society collaborate

Thursday, October 2, 2014 02:08 PM

Glialogix, a San Francisco Bay Area-based emerging biopharma company, has entered into a sponsored research agreement with Fast Forward, a nonprofit organization established by the New York-based National Multiple Sclerosis (MS) Society to accelerate the development of treatments for MS. Fast Forward will provide funding for preclinical studies of GLX1112, a first-in-class neuroprotective therapy designed to slow the accumulation of disability in progressive MS.

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CytRx receives multiple FDA Orphan Drug designations for Aldoxorubicin

Thursday, October 2, 2014 01:50 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has granted multiple Orphan Drug designations for the company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.

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FDA awards grants to stimulate drug, device development for rare diseases

Wednesday, October 1, 2014 01:27 PM

The FDA has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.

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Clinical Conductor CTMS, OpenClinica EDC partner

Wednesday, October 1, 2014 01:17 PM

Clinical Conductor CTMS, a Rochester, N.Y.-based provider of clinical trial management system, and OpenClinica, a Waltham, Mass.-based provider of global electronic data capture (EDC) software platforms, have partnered to deliver a seamless EDC-CTMS integration to drive productivity in clinical research.

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LabConnect uses custom approach to enhance clinical data mining

Wednesday, October 1, 2014 01:16 PM

LabConnect, a Seattle, Wash.-based provider of central laboratory services to the biopharmaceutical industry, has released its BioVisualization software platform.

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Catalent, Cingulate Therapeutics ink agreement for new ADHD treatments

Tuesday, September 30, 2014 09:00 AM

Catalent Pharma Solutions, headquartered in Somerset, N.J., has reached an exclusive development and licensing agreement with Cingulate Therapeutics (CTx), a Morristown, N.J.-based, privately held biopharmaceutical company, to support development of a series of new prescription pharmaceutical products for the treatment of attention deficit/hyperactivity disorder (ADHD) using Catalent's OSDrC OptiDose drug delivery platform.

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Novo Nordisk establishes obesity research unit in Seattle

Tuesday, September 30, 2014 08:00 AM

Novo Nordisk will establish a new obesity research unit in Seattle, Wash. The new unit is a result of Novo Nordisk's increasing focus on obesity. Its main task will be to identify novel approaches and targets for obesity treatments, while increasing the scientific understanding of existing obesity targets.

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Soligenix awarded $24.7M NIAID contract for heat stable RiVax vaccine

Friday, September 26, 2014 03:05 PM

Soligenix, a Princeton, N.J.-based late-stage biopharmaceutical company developing products that address unmet medical needs in inflammation, oncology and biodefense, has been awarded a contract valued at up to $24.7 million inclusive of options by the U.S. Department of Health and Human Service's NIH, specifically funded by the National Institute of Allergy and Infectious Diseases (NIAID). The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax, combined with the company's ricin toxin vaccine, Rivax, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.

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Aethlon Medical, Exosome Sciences to collaborate with BU CTE Center

Friday, September 26, 2014 03:00 PM

Aethlon Medical and its New Jersey-based diagnostic subsidiary Exosome Sciences (ESI) have established a clinical collaboration with the Boston University (BU) CTE Center to advance a blood-based diagnostic candidate that could identify Chronic Traumatic Encephalopathy (CTE) in living individuals.

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Amgen submits BLA for investigational BiTE immunotherapy blinatumomab

Thursday, September 25, 2014 02:55 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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First Sunshine Act data posted online; many cite errors, lack of context to help consumers understand payments

In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

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CROs driving changes in patient recruitment
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Higher expense, but may improve recruitment and retention for select trials

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Standout sponsors reveal how they shorten regulatory, clinical cycle times

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