NIH

Xcovery joins NCI Formulary to help expedite cancer clinical trials

Wednesday, January 18, 2017

Xcovery, a developer of targeted therapeutics for cancer, has announced its participation in the NCI Formulary, a public-private partnership between the National Cancer Institute (NCI), part of the NIH, and pharmaceutical and biotechnology companies to expedite the use of agents in clinical trials. The partnership, which launched last week with fifteen targeted agents from six pharmaceutical companies, will seek to alleviate the lengthy process to develop new therapies for patients, and respond to the call for greater collaboration within the industry made by Vice President Biden’s Cancer Moonshot Initiative.

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NCI’s new drug formulary will expedite agent use in clinical trials

Wednesday, January 11, 2017

The National Cancer Institute (NCI) has launched a new drug formulary that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

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University of Pittsburgh, Bayer form research alliance

Wednesday, January 11, 2017

The University of Pittsburgh and Bayer have established a master collaboration agreement to advance research for heart, lung and blood disease indications. This broad collaboration spans from early research studies, to drug development and big data analysis including real-world evidence studies. In addition to the research partnership, Bayer will be supporting an independent investigator-initiated clinical trial in sickle cell disease.

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Viriom, NIH partner on Zika and other major viral diseases

Monday, January 9, 2017

Viriom has entered into a collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to identify new drug candidates for treatment of the Zika and other important virus infections. Under the collaboration agreement, Viriom and Dr. Leo Margolis of NICHD will study and improve the antiviral properties of Viriom’s lead compounds against the Zika virus, HBV, HCV, HIV, RSV and other clinically relevant viruses.

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GeoVax forms scientific advisory board

Tuesday, January 3, 2017

GeoVax Labs, a biotechnology company specializing in developing human vaccines, has announced the formation of its inaugural Scientific Advisory Board (SAB) to provide expert guidance as the company advances its vaccine development for multiple targets including HIV, hemorrhagic fever (Ebola, Sudan, Marburg, Lassa), Zika virus, chronic Hepatitis B and immuno-oncology.

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Early-phase trial demonstrates shrinkage in pediatric neural tumors

Tuesday, January 3, 2017

In an early-phase clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, in most cases, responded to it with tumor shrinkage. NF1 affects 1 in 3,000 people. The study results appeared Dec. 29, 2016, in the New England Journal of Medicine.

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HHS appoints Quorum’s Dr. Stephen Rosenfeld SACHRP Chair

Wednesday, December 21, 2016

Dr. Stephen J. Rosenfeld, executive IRB chair for Quorum Review IRB, has accepted an invitation from Sylvia Burwell, the Secretary of the Department of Health and Human Services (DHHS), to chair the Secretary’s Advisory Committee for Human Research Protections (SACHRP). SACHRP comprises experts in the fields of research and ethics, and provides advice and recommendations to the Secretary of DHHS on issues pertaining to the protection of human subjects in research.

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An exciting year for the medical technology industry

Monday, December 19, 2016

The Pulse on Global Trials by Matthew Howes

In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

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ACRES, BSI collaborate on clinical research sites standards

Tuesday, December 13, 2016

The Alliance for Clinical Research Excellence and Safety (ACRES), in partnership with the British Standards Institution (BSI), has launched a multi-stakeholder global working party to fast-track development of standards for all aspects of site work, laying the foundation for recognizing and rewarding excellence at clinical research sites worldwide and accelerating development of safe and effective new medicines.

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Major General James Gilman, M.D., to lead NIH Clinical Center

Monday, December 12, 2016

NIH Director Francis S. Collins, M.D., Ph.D., has announced the selection of Major General James K. Gilman, M.D., U.S. Army (Retired), as the inaugural chief executive officer of the NIH Clinical Center, the nation’s largest hospital devoted to clinical research. Dr. Gilman is expected to join in early January 2017.

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