Theorem Clinical Research

United States

Report: Inventor incentives could spur medical innovation, cut spending

Wednesday, April 23, 2014 01:55 PM

To help rein in massive healthcare spending, a new RAND study concludes U.S. policymakers should urgently find ways to incentivize pharmaceutical companies and device makers to develop products that produce more value. RAND is a research organization that develops solutions to public policy challenges.

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Scripps Florida Scientists awarded $2M for anti-diabetic drug design

Wednesday, April 23, 2014 01:46 PM

The NIH has awarded scientists from the Florida campus of The Scripps Research Institute (TSRI) $2.1 million to study the therapeutic potential of safer and more effective alternatives to the current crop of anti-diabetic drugs, which have been limited in their use due to side effects including bone loss and congestive heart failure.

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GSK, Genmab receive FDA approval for Arzerra (ofatumumab) for CLL

Monday, April 21, 2014 09:27 AM

GlaxoSmithKline and Genmab have announced that the FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

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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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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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CWWeekly

September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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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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The CenterWatch Monthly

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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