United States

PPD selected as member of new Medical Countermeasure Clinical Studies Network

Friday, March 14, 2014 11:18 AM

The Biomedical Advanced Research and Development Authority (BARDA) has chosen global CRO Pharmaceutical Product Development (PPD) as one of a select group to design and conduct clinical studies needed to develop medical countermeasures—drugs, vaccines and diagnostic tests—that help protect health against bioterrorism, pandemic influenza and other public health emergencies.

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WIRB Copernicus Group

Northwestern Memorial HealthCare, Cadence Health pursue merger

Friday, March 14, 2014 10:26 AM

Cadence Health and Northwestern Memorial HealthCare (NMHC) have agreed to discuss forming an integrated academic healthcare delivery system. Cadence Health is the corporate parent of Central DuPage Hospital and Delnor Hospital, and NMHC owns Northwestern Memorial Hospital and Northwestern Lake Forest Hospital.

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CRF Health eCOA webinar series

CFS Clinical sponsors STEM event

Thursday, March 13, 2014 01:33 PM

Statistics continue to show girls are not embracing careers in technology, despite an increasing need for skilled professionals in STEM (Science, Technology, Engineering and Math) fields in the nation. Girls Exploring Tomorrow’s Technology (GETT) promotes academic achievement in all girls in sixth to twelfth grade in the Delaware Valley and introduces them to the idea of potentially having a future in technology.

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ClinicalRM awarded BARDA contract

Thursday, March 13, 2014 12:57 PM

Clinical Research Management (ClinicalRM), a full-service CRO providing support for basic and applied research, clinical trials and regulatory support, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA). With this contract award, ClinicalRM becomes part of a clinical studies network being established by BARDA to support development of vaccines, drugs and diagnostics, known as medical countermeasures, needed to protect health and potentially save lives in public health emergencies. The network will provide clinical services in support of adequate and well-controlled phase I through IV clinical trials or trials during a public health emergency, and will support the evaluation of chemical, biological, radiological, nuclear, pandemic influenza and emerging infectious disease medical countermeasures.

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PhRMA launches national campaign to increase diversity in clinical trials

Thursday, March 13, 2014 12:55 PM

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum have announced a first-of-its-kind national campaign to help increase diversity in clinical trials.

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Upsher-Smith receives FDA approval for Qudexy XR (topiramate)

Thursday, March 13, 2014 11:15 AM

Upsher-Smith Laboratories has received FDA approval for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.  It also is approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014.

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NIH awards Seattle BioMed $9.8M to develop HIV/AIDS vaccine

Wednesday, March 12, 2014 02:54 PM

Seattle BioMed, an independent, nonprofit organization focused solely on infectious disease research, has received a seven-year Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a vaccine that would elicit broadly neutralizing antibodies against HIV-1.

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FDA approves AVEED injectable testosterone replacement therapy

Thursday, March 6, 2014 08:51 AM

Endo Pharmaceuticals, a global specialty healthcare company, has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

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Human Longevity launched to promote healthy aging

Wednesday, March 5, 2014 01:13 PM

Human Longevity (HLI), a genomics and cell therapy-based diagnostic and therapeutic company focused on extending the healthy, high-performance human life span, has been launched by co-founders J. Craig Venter, Ph.D., Robert Hariri, M.D., Ph.D., and Peter H. Diamandis, M.D.

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MEI Pharma receives Orphan status for AML treatment Pracinostat

Monday, March 3, 2014 11:16 AM

MEI Pharma, a San Diego-based oncology company focused on the clinical development of novel therapies for cancer, has announced that the FDA has granted orphan drug designation to the company's investigational drug Pracinostat for the treatment of acute myeloid leukemia (AML).

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