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Arsenal Capital acquires Synchrogenix for regulatory writing, submission services, will merge it with Certara

Tuesday, April 15, 2014 01:11 PM

Arsenal Capital Partners, a private equity firm that acquired software and scientific consulting services provider Certara last December, now has purchased Synchrogenix, an independent regulatory-writing CRO, and will merge the two.

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CRF Health eCOA webinar series

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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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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CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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