United States

Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

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Quest Diagnostics

INC enhances clinical delivery focus with executive leadership promotions

Thursday, January 22, 2015 01:38 PM

INC Research Holdings, a, global phase I to IV CRO based in Raleigh, N.C., has announced the promotions of Alistair Macdonald and Michael Gibertini, Ph.D., to key roles within the C-suite.

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med fusion expands solid tumor profiling services

Thursday, January 22, 2015 12:20 PM

med fusion, an integrated Molecular Center of Excellence and clinical trials service organization headquartered in Lewisville, Texas, has released its solid tumor molecular profiling testing services (SEQ) enhanced by next generation sequencing (NGS) technology. The introduction of NGS will further enable physicians to interrogate their patient’s tumor at the molecular level in order to develop a personalized treatment plan according to the genetic makeup of their specific tumor.

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SV Bio renames itself Lifecode, launches oncology assay

Thursday, January 22, 2015 12:17 PM

Silicon Valley Biosystems (SV Bio) has changed its name to Lifecode. The new name is consistent with the company's mission to improve the lives of patients by providing concise, accurate and actionable molecular information. Lifecode also has released its flagship next generation sequencing (NGS)-based oncology assay, the Pan Cancer Somatic Panel (PCSP), to a select group of physicians nationwide in advance of a broad launch later this spring.

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Report: Midwest healthcare companies raise $1.8B in 2014

Wednesday, January 21, 2015 01:06 PM

Midwest healthcare companies attracted $1.8 billion in new investments across 243 companies in 2014, according to the BioEnterprise Midwest Healthcare Growth Capital Report. The totals are the highest recorded in both dollars and number of companies funded since BioEnterprise began compiling the report in 2005, surpassing the banner 2007 by 46% and 2013 by 135%. BioEnterprise is a business formation, recruitment, and acceleration initiative designed to grow healthcare companies and commercialize bioscience technologies based in Cleveland, Ohio.

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FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

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TapImmune reports positive immune responses in phase I cancer trial

Friday, January 16, 2015 01:08 PM

TapImmune, an immunotherapy company, has reported the completion of data analysis from all 21 evaluable patients treated in a phase I clinical trial. In addition, the recent financing provides immediate, short term and long term access to the capital required to execute its exclusive option to license these very promising peptides and to progress its on-going clinical program into phase II trials.

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FDA approves VBLOC vagal blocking therapy for obesity

Friday, January 16, 2015 12:52 PM

The FDA has approved medical device company EnteroMedics’ VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

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35 partners from industry and academia collaborate on European research initiative

Thursday, January 15, 2015 01:40 PM

The European Prevention of Alzheimer's Dementia (EPAD) initiative has begun a novel collaboration between academic and private sectors to test innovative treatments for the prevention of Alzheimer’s dementia.

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Crohn's & Colitis Foundation of America, ResearchMatch partner

Wednesday, January 14, 2015 12:32 PM

ResearchMatch, a U.S.-wide, disease-neutral, volunteer research recruitment and engagement platform, is partnering with the Crohn's & Colitis Foundation of America (CCFA), a volunteer-driven organization dedicated to curing Crohn's disease and ulcerative colitis, and improving the quality of life of children and adults affected by those diseases.

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CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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