United States

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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WIRB Copernicus Group

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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Upsher-Smith announces positive data for epilepsy drug USL261

Friday, May 2, 2014 12:23 PM

Upsher-Smith Laboratories has announced positive phase I data for USL261 (investigational intranasal midazolam) in patients with epilepsy. Results demonstrated that USL261 at a single dose of up to 7.5mg was rapidly absorbed and exhibited a short half-life. Additionally, USL261 generally was well-tolerated in patients with epilepsy and demonstrated a rapid onset of pharmacodynamic effects with return to baseline function by four hours post dose.

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The Buoniconti Fund, Permobil partner for mobility research awareness

Thursday, May 1, 2014 10:20 AM

Nick and Marc Buoniconti, in conjunction with the Buoniconti Fund to Cure Paralysis, the fundraising arm of the Miami Project to Cure Paralysis, have announced a partnership with Permobil, a wheelchair provider, to jointly promote mobility and paralysis research awareness.

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FDA approves Zykadia for late-stage lung cancer

Wednesday, April 30, 2014 03:01 PM

The FDA has granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

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Wisconsin awards grant to Bridge to Cures to commercialize university R&D

Wednesday, April 30, 2014 11:32 AM

In an effort to deliver the benefits of medical discovery to patients seeking relief, the Wisconsin Economic Development Corporation (WEDC) has awarded a $140,000 grant to Bridge to Cures (B2C), a new nonprofit, to establish a new seed fund. The matching grant will enable B2C to provide seed money to entrepreneurs at academic institutions in southeastern Wisconsin seeking to translate their medical research and inventions into products and companies in the healthcare space.

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Rutgers receives $26M antibiotics grant from NIH

Wednesday, April 30, 2014 11:26 AM

The National Institute of Allergy and Infectious Diseases (NIAID) of the NIH has selected infectious disease expert David Perlin, executive director of the Public Health Research Institute at Rutgers New Jersey Medical School, to lead a major research effort aimed at developing new forms of antibiotics to regain the upper hand over deadly bacteria that have become resistant to current treatments.  

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Michael S. Gordon named medical director for cancer center trials at Scottsdale Healthcare

Friday, April 25, 2014 11:21 AM

Michael S. Gordon, M.D., has been named the new medical director for the Virginia G. Piper Cancer Center Clinical Trials program at Scottsdale Healthcare. Gordon will oversee the center's phase I clinical trials program. Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with Translational Genomics Research Institute, is a clinical research site for phase I studies of new cancer drugs.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

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Benefits outweigh the complexities, challenges of finding right vendors

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Lessons learned from medical device trials
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