United States

FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

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WIRB Copernicus Group

CTI Clinical Trial and Consulting Services to open new office

Thursday, April 3, 2014 10:58 AM

CTI Clinical Trial and Consulting Services, a global, privately held, full-service CRO, will relocate the company’s Consulting and Health Economics and Outcomes Research (HECOR) divisions to University Station adjacent to the Xavier University campus in Cincinnati, Ohio.

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FDA grants IND approval for CardioCell’s phase IIa itMSC Therapy trial

Wednesday, April 2, 2014 03:41 PM

CardioCell, a global biotechnology company, has just received the FDA’s Investigational New Drug (IND) approval for a U.S.-based, phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Preparation is underway to initiate the study at Emory University, Northwestern University and the University of Pennsylvania in May 2014.

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Society for Women’s Health Research urges FDA to require trials to examine gender-based differences

Wednesday, April 2, 2014 02:09 PM

Seeking to increase the participation of women and minorities in all phases of clinical trials, along with greater reporting and analysis of gender differences, Phyllis Greenberger testified at an FDA hearing yesterday. She presented a series of recommendations and changes to how the agency handles the collection, analysis and availability of demographic subgroup data in applications for FDA-regulated medical products.  

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Congress approves one-year renewal diabetes research funding

Wednesday, April 2, 2014 01:51 PM

The U.S. Senate has approved legislation for a one-year extension of the Special Diabetes Program (SDP)—an initiative that accounts for roughly one-third of all federally funded type 1 diabetes (T1D) research in the U.S. The decision comes on the heels of the March 27 approval of the legislation by the U.S. House of Representatives, and will extend SDP funding for the National Institutes of Health (NIH) at the current level of $150 million, as part of the “Protecting Access to Medicare Act of 2014.”

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Institute for Genome Sciences to expand genome sequence database

Wednesday, April 2, 2014 01:49 PM

Researchers at the Institute for Genome Sciences at the University of Maryland School of Medicine have been awarded a research program contract from the FDA to sequence, assemble and annotate a population of bacterial pathogens using two high-throughput sequencing (HTS) technologies in support of the expansion of a vetted public reference database.

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Perficient acquires BioPharm Systems

Wednesday, April 2, 2014 01:43 PM

Perficient, an information technology consulting firm serving Global 2000 and other large enterprise customers throughout North America, has acquired BioPharm Systems, a business and information technology consulting firm focused on the life sciences industry, for approximately $17.6 million, including about $11.4 million in cash and $6.2 million of Perficient common stock.

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Potential Parkinson's Therapy secures $23M for testing from NIH

Monday, March 31, 2014 01:40 PM

Results of a study funded by the Michael J. Fox Foundation (MJFF) for Parkinson's Research have enabled researchers to secure a $23 million grant from the NIH, continuing a repurposed drug approved for hypertension to phase III testing for slowing Parkinson's progression. The trial investigating the compound isradipine will be the most advanced, current study into a disease-modifying therapy for Parkinson's disease (PD), an unmet need.

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Rho selected by HHS for clinical studies network

Monday, March 31, 2014 01:38 PM

CRO Rho’s Federal Systems Division has been selected by the U.S. Department of Health and Human Services (HHS) to be part of a network of five CROs that will design and conduct clinical studies needed to develop medical countermeasures—drugs, vaccines and diagnostic tests that help protect public health against bioterrorism, pandemic influenza and other health emergencies. 

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North Shore InnoVentures receives $1.65M from Massachusetts Life Sciences Center

Monday, March 31, 2014 01:29 PM

North Shore InnoVentures (NSIV), a New England technology incubator and business accelerator, has received a capital grant of $1.65 million from the Massachusetts Life Sciences Center (MLSC). The grant will allow NSIV to expand its current laboratory facilities over the next three years and purchase advanced analytical instrumentation. This grant is part of a larger $5 million award to the Life Sciences Consortium of the North Shore (LSCNS), consisting of Endicott College, Gordon College, North Shore InnoVentures, North Shore Community College and Salem State University, that will fund major lab/facility and equipment upgrade projects at the member institutions and organizations.

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August 18

Ebola outbreak highlights need to improve biosafety, infrastructure to handle future health emergencies

More African American professional women open to participating in medical research

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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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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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