United States

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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WIRB Copernicus Group

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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CRF Health eCOA webinar series

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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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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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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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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June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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