Theorem Clinical Research

Global News

VentiRx Pharmaceuticals receives Fast Track designation for Motolimod (VTX-2337)

Friday, September 5, 2014 10:59 AM

The FDA has granted Fast Track designation to VentiRx Pharmaceuticals’ motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled, phase II trials.

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Frost & Sullivan honors Clinical Ink for eSource platform that streamlines clinical development

Friday, September 5, 2014 10:56 AM

Based on its recent analysis of the eClinical solutions market, Frost & Sullivan recognizes Clinical Ink with the 2014 North American eClinical Solutions Award for Entrepreneurial Company of the Year. The award recognizes Clinical Ink's innovative SureSource platform—the first purpose-built eSource solution that captures data electronically at the point of care.

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Oncolytics Biotech completes patient enrollment in phase II ovarian cancer study

Friday, September 5, 2014 09:53 AM

Oncolytics Biotech has completed patient enrollment in a randomized, phase II study of paclitaxel plus reolysin versus paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

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Tracy Tsuetaki joins Parexel as senior vice president

Friday, September 5, 2014 09:34 AM

Parexel International, a global biopharmaceutical services provider, has appointed Dr. Tracy Tsuetaki as senior vice president for peri/post-approval services and Parexel consulting. He will oversee the strategy and operational management for both businesses. He also will be on Parexel's business review committee.

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AbbVie, Calico launch R&D collaboration for age-related diseases

Thursday, September 4, 2014 12:35 PM

Chicago-based AbbVie and Calico, a California-based Google-founded R&D company, have announced a novel R&D collaboration intended to help the two companies discover, develop and bring to market new therapies for patients with age-related diseases, including for neurodegeneration and cancer.

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Redx Pharma, AstraZeneca collaborate

Thursday, September 4, 2014 12:34 PM

Redx Pharma, a U.K.-based group focused on early stage drug discovery and development, has entered into a research collaboration with AstraZeneca to discover and develop new molecules targeting a genetic driver of tumor growth and survival.

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Infinity, AbbVie partner to develop, commercialize oncology drug duvelisib

Thursday, September 4, 2014 12:28 PM

Infinity Pharmaceuticals, based in Cambridge, Mass., and AbbVie have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, to treat cancer.

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DPT Laboratories acquires Meda Pharmaceuticals’ facility, retains employees

Thursday, September 4, 2014 12:21 PM

DPT Laboratories, a Texas-based contract development and manufacturing organization (CDMO) with a specialized focus on semi-solid and liquid dosage forms, has acquired Meda Pharmaceuticals’ Lakewood, N.J., facilities.

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Synexus acquires South African site, expands global footprint

Wednesday, September 3, 2014 12:46 PM

Synexus, a U.K.-based site management organization, has expanded its global presence with the acquisition of a specialist clinical trial site close to Cape Town's international airport. This is its fourth dedicated research center in South Africa and brings Synexus’ global site count to 24, with three new centers opened in the last six months.

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Exelixis cuts 70% of employees following failed pivotal trial

Wednesday, September 3, 2014 12:41 PM

Exelixis, a California-based biopharmaceutical company developing small molecule therapies for cancer, has announced top-line results from the final analysis of COMET-1, the phase III pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

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September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

Cutting-edge advertising can ‘break through the clutter’ for successful patient recruitment

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September

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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August

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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