Theorem Clinical Research

United States

FDA approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant)

Monday, May 12, 2014 12:35 PM

The FDA has approved a new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25IU/kg three times per week) or on-demand treatment.

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FDA approves Zontivity to reduce risk of heart attacks and stroke

Friday, May 9, 2014 12:50 PM

The FDA has approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

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Moffitt Cancer Center, Vermillion collaborate

Friday, May 9, 2014 12:32 PM

The Moffitt Cancer Center in Tampa, Fla., and Austin-based Vermillion have announced a research collaboration, launching a study to produce clinical and economic data to support a new value-based practice model that may improve survival, quality of life and cost-effectiveness of care for patients with ovarian cancer.

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FDA approves EPANOVA for severe hypertriglyceridemia

Wednesday, May 7, 2014 02:43 PM

AstraZeneca has announced the FDA approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

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ACRP CCRC designation recognized by American Nurses Credentialing Center

Wednesday, May 7, 2014 01:34 PM

The Association of Clinical Research Professionals' (ACRP) Certified Clinical Research Coordinator (CCRC) designation now is recognized by the American Nurses Credentialing Center (ANCC) as a valid designation toward meeting staffing requirements of the ANCC Magnet Recognition Program.

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FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

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PhRMA: More than 100 medicines for mental health disorders in development

Wednesday, May 7, 2014 01:29 PM

America’s biopharmaceutical research companies currently are developing 119 novel new medicines to help improve the lives of the estimated 61.5 million Americans affected by mental health disorders, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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FDA launches Center of Excellence in drug development, regulation at UCSF

Wednesday, May 7, 2014 01:26 PM

The FDA has selected UC San Francisco (UCSF) as the site of a new regulatory science center on the West Coast. The center, which will be a joint effort between scientists in the UCSF School of Pharmacy and Stanford University, aims to spur innovative approaches in drug development that will support the FDA's ability to evaluate and approve safe and effective new medications.

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Aeterna Zentaris to house business, commercial operations in Charleston, S.C.

Wednesday, May 7, 2014 01:12 PM

Aeterna Zentaris, a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology, has selected Charleston, S.C., for its North American business and global commercial operations. Over the next five years, Aeterna Zentaris will hire staff to support commercial operations, business development, regulatory and quality assurance, manufacturing management, clinical and product development, as well as various administrative functions. The Coordinating Council for Economic Development of South Carolina has approved job development credits to Aeterna Zentaris.

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Study: $260M spent on Women’ Health Initiative trial has saved $37B in healthcare costs over 10 years

Tuesday, May 6, 2014 12:34 PM

Critics opposed to hefty government research spending may think twice after learning that a 15-year, $260 million federally funded study—known as the Women’s Health Initiative (WHI) estrogen plus progestin clinical trial—showed changes in medical practice stemming from the trial provided a net economic return of $37.1 billion over a 10-year period—or about $140 on every federal dollar invested in the trial.

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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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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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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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