Theorem Clinical Research

R&D Trends

Epic Sciences, Prostate Cancer Clinical Trials Consortium collaborate

Monday, March 9, 2015 12:22 PM

Epic Sciences, a San Diego, Calif.-based developer of novel diagnostics to personalize and advance the treatment and management of cancer, and the Prostate Cancer Clinical Trials Consortium (PCCTC), a consortium for phase I/II and phase II clinical trials in prostate cancer, will collaborate to apply Epic's circulating tumor cell (CTC) technology in multiple investigator-initiated clinical trials to advance the development of new prostate cancer treatments.

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Quest Diagnostics

Targacept, Catalyst Biosciences ink merger

Monday, March 9, 2015 12:20 PM

Targacept, a biopharma company based in Winston-Salem, N.C., and Catalyst Biosciences, a privately held biopharma company based in South San Francisco, Calif., have agreed to merge. The combined entity, to be named Catalyst Biosciences, is expected to create a financially strong company to harness the catalytic power of engineered human proteases to develop next-generation biopharmaceuticals with improved efficacy and therapeutic index to treat major diseases.

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Biomarkers Across Neurodegenerative Diseases launches $2M funding cycle

Monday, March 9, 2015 12:15 PM

Biomarkers Across Neurodegenerative Diseases (BAND) is launching a new funding cycle of nearly $2 million for projects investigating the overlap in the biology and clinical symptoms of Alzheimer's, Parkinson's, frontotemporal dementia (FTD) and other brain-deteriorating diseases.

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NIH-led effort launches Big Data portal for Alzheimer’s drug discovery

Friday, March 6, 2015 12:16 PM

A NIH-led public-private partnership to transform and accelerate drug development has launched a new Alzheimer’s Big Data portal—including delivery of the first wave of data—for use by the research community. The new data sharing and analysis resource is part of the Accelerating Medicines Partnership (AMP), an unprecedented venture bringing together NIH, FDA, industry and academic scientists from a variety of disciplines to translate knowledge faster and more successfully into new therapies.

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The Bill & Melinda Gates Foundation, CureVac collaborate

Friday, March 6, 2015 12:11 PM

The Bill & Melinda Gates Foundation has made a commitment to invest $52 million in CureVac, a Germany-based, clinical-stage biopharmaceutical company specializing in mRNA-based vaccine technologies.

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Mayo Clinic, Gentag to develop wireless sensors for treatment of obesity and diabetes

Thursday, March 5, 2015 12:35 PM

Mayo Clinic, a nonprofit organization based in Rochester, Minn., and Gentag, a wearable biosensor company based in Washington, D.C., have reached an agreement to develop the next generation of wearable biosensors designed to fight obesity and diabetes.

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Eisai, Merck collaborate on combination regimens for cancer

Thursday, March 5, 2015 12:29 PM

Eisai and Merck, through a subsidiary, have formed a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (marketed in the U.S. under the brand name Keytruda), in combination with Eisai oncology compounds lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the U.S. under the brand name Lenvima, lenvatinib) and eribulin mesylate (a microtubule dynamics inhibitor marketed in nearly 60 countries including Japan, the U.S. and Europe under the brand name Halaven, eribulin) in multiple clinical trials.

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Denovo Biopharma licenses late-stage neuroscience drug from Eli Lilly

Wednesday, March 4, 2015 01:15 PM

Denovo Biopharma, a privately held biotechnology company based in San Diego, has exclusively licensed Pomaglumetad Methionil (mGlu2/3 receptor agonist), a late-stage neuroscience drug, from Eli Lilly. Denovo gains all rights to develop, manufacture and commercialize pomaglumetad globally, including transfer of all intellectual property and other rights, data and information. Lilly has an option to re-acquire pomaglumetad upon a successful clinical trial, for predetermined undisclosed financial terms.

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Kite Pharma expands R&D collaboration with National Cancer Institute

Wednesday, March 4, 2015 01:11 PM

Kite Pharma, a clinical stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer based in Santa Monica, Calif., has amended its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

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CCFA, University of Pennsylvania, Nestlé collaborate on IBD study

Wednesday, March 4, 2015 01:09 PM

The Crohn's & Colitis Foundation of America (CCFA) has entered into a research partnership with the Perelman School of Medicine at the University of Pennsylvania and Nestlé Health Science to study the effects of diet on gut bacteria. The study is part of a major CCFA effort to develop new treatments targeting the gut microbiome—the "ecosystem" of microbes populating the intestines—linked to the development of inflammatory bowel diseases (IBD).

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CWWeekly

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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The CenterWatch Monthly

March

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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The CenterWatch Monthly

February

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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