Theorem Clinical Research

Clinical Intelligence

Array BioPharma initiates MILO study

Tuesday, July 9, 2013 12:36 PM

Array BioPharma said a $5 million milestone was achieved after the start of Array's phase III trial in patients with low-grade serous ovarian cancer (LGSOC).

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KaloBios updates pipeline of clinical programs

Wednesday, July 3, 2013 02:19 PM

KaloBios Pharmaceuticals has updated the status of its ongoing clinical programs for KB003, KB001-A and KB004, its pipeline of proprietary monoclonal antibodies in development for severe respiratory diseases and cancer.

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Morphotek announces initiation of phase I study for MORAb-066

Wednesday, July 3, 2013 02:16 PM

Biopharmaceutical Morphotek, a subsidiary of Eisai, has announced that the Sarah Cannon Research Institute in Nashville, Tenn., has opened enrollment in a phase I clinical study with MORAb-066 in patients with advanced or metastatic breast, pancreatic, colorectal or non-small cell lung cancer (adenocarcinoma) malignancies. The open-label, phase I study will assess the safety, tolerability and pharmacokinetics of MORAb-066 administered with weekly intravenous infusions.

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Advanced Clinical Care recruiting for psoriasis trials

Wednesday, July 3, 2013 02:14 PM

Advanced Clinical Care, a Massachusetts clinical trial center, is recruiting patients for two plaque psoriasis clinical trials. Advanced Clinical Care previously has run and completed trials involving rheumatic disease. With these trials the researchers will gain knowledge about the two treatment medications for people suffering with plaque psoriasis. Both trials run for five years, providing patients free care and free medication for the entire duration of the study.

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AtheroNova initiates phase I clinical trial of AHRO-001

Wednesday, July 3, 2013 08:54 AM

AtheroNova, a biotech company focused on the R&D of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, has initiated a phase I clinical trial with its compound, AHRO-001, to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with licensing partner OOO CardioNova.

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Soligenix completes phase I in SGX203 for pediatric Crohn’s

Wednesday, July 3, 2013 08:50 AM

Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, has enrolled and treated all patients in the phase I study BDP-PCD-01, a clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The SGX203 development program previously has received Fast Track and Orphan Drug designations from the FDA.

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The CenterWatch Monthly, July 2013

Monday, July 1, 2013 02:01 PM

CISCRP looks inside patients’ perceptions, motives

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CryoLife receives conditional IDE approval

Tuesday, June 25, 2013 03:45 PM

CryoLife, a tissue processing and medical device company focused on cardiac and vascular surgery, has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the FDA.

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Grunenthal expands use of BioClinica's Trident

Tuesday, June 25, 2013 12:43 PM

BioClinica, a global provider of clinical trial management solutions, has announced international research-based pharmaceutical Grunenthal will utilize enhancements in Trident IWR/IVR for a global study on pain medication. The three year study will involve 350 patients at 80 sites across 17 countries.

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TWi Biotechnology completes phase II trial patient enrollment

Monday, June 24, 2013 03:44 PM

TWi Biotechnology has completed patient enrollment in a phase II trial of AC-201 for Gout Flare Prophylaxis (GFP) during urate-lowering therapy (ULT). This randomized, double-blind, placebo-controlled phase II study is conducted in eight medical centers in Taiwan and includes patients with acute arthritis of primary gout and elevated serum uric acid. A total of 82 patients were randomized at a 1:1 ratio to receive 50mg AC-201 or placebo twice daily in addition to the ULT during the 16-week treatment period.

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September 22

Roche/Genentech plans pilot trial to measure patientpreference for participating at home v. at study site

Bipartisan 21st Century Cures initiative prepares to draft legislation to accelerate biomedical R&D, lower cost

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The CenterWatch Monthly


Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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