Theorem Clinical Research

United States

FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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Sangamo BioSciences, City of Hope granted $5.6M from CIRM

Friday, May 30, 2014 01:36 PM

The California Institute for Regenerative Medicine (CIRM) has granted a $5.6 million Strategic Partnership Award to fund clinical studies at City of Hope to develop a potentially curative ZFP therapeutic for HIV/AIDS based on the application of SangamoBioSciences' zinc finger nuclease (ZFN) genome-editing technology in hematopoietic stem/progenitor cells (HSPCs).

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Trimel receives FDA approval for Natesto Nasal Gel male low testosterone

Friday, May 30, 2014 01:33 PM

The FDA has approved Trimel Pharmaceuticals’ Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.

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FDA approves ALOXI for pediatric, chemotherapy-induced nausea

Thursday, May 29, 2014 01:50 PM

Eisai and Helsinn Group have announced the FDA approval of ALOXI (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged one month to less than 17 years.

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Cancer Treatment Centers of America names Maurie Markman president

Thursday, May 29, 2014 01:39 PM

Cancer Treatment Centers of America (CTCA), a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer, has appointed Maurie Markman, M.D., president of the company's Medicine & Science unit, where he will be responsible for advancing the organization's overall commitment to clinical excellence, innovation, safety and patient satisfaction. Markman was senior vice president of Clinical Affairs and national director of Medical Oncology at CTCA.

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NIA/NIH grants $1.4M to Cognition Therapeutics' Alzheimer's program

Friday, May 23, 2014 02:35 PM

Cognition Therapeutics, an innovative research and drug discovery organization focused on the development of novel disease-modifying therapeutics for neurodegenerative diseases, has announced that its small molecule soluble Abeta receptor antagonist program for the treatment of Alzheimer's disease (AD) has been selected for funding by the National Institute on Aging (NIA)/NIH Alzheimer's Disease Drug Development Program. This cooperative agreement program for Alzheimer's disease translational research will provide Cognition Therapeutics with an estimated $1.4M in funding over four years to support critical drug development activities aimed at securing IND status for the company's first-in-class therapeutics.

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Jack Modell joins Rho as senior medical officer

Thursday, May 22, 2014 11:15 AM

Rho, a privately held CRO located in Chapel Hill, N.C., has announced that Dr. Jack Modell joined its team as senior medical officer, bringing 20 years of experience in clinical research, teaching and patient care in academic medicine, and an additional 10 years of experience in clinical drug development (phase II-IV), medical affairs, medical governance, drug safety and management within the pharmaceutical industry. 

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Inhibikase Therapeutics receives Orphan Drug Designation for PML

Thursday, May 22, 2014 11:08 AM

Inhibikase Therapeutics, a developer of products to treat infectious diseases with little or no resistance, has received Orphan Drug Designation for imatinib to treat progressive multifocal leukoencephalopathy (PML) from the FDA.

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Report: Value of U.S. health services M&A deals up 152%

Wednesday, May 21, 2014 01:29 PM

U.S. health services M&A total deal value rose 152% to $12.3 billion during the first quarter of 2014 compared to the same period in 2013, according to an analysis of M&A trends and outlook for the health services sector issued by PricewaterhouseCoopers U.S.

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PDS launches first publicly available, FDA-validated dataset for SEND

Wednesday, May 21, 2014 01:28 PM

PDS, a global provider of intuitive data management software and solutions for life sciences research, has made an FDA-validated, preclinical research SEND dataset available to the public free of charge and qualification.

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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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The CenterWatch Monthly

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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