Centers for Disease Control and Prevention

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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Regulatory Update, December 2016

Thursday, December 1, 2016

FDA Publishes Final Guidance Documents

The FDA published these final guidance documents. Interested parties may submit electronic or written comments on these guidance documents as instructed for the first document and with the indicated Docket Number included in the comments.

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Federal prize competition seeks innovative ideas to combat antimicrobial resistance

Tuesday, September 13, 2016

A federal prize competition launched calling for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug resistant bacteria, a rising public health threat. Antibiotic resistant bacteria cause at least 2 million infections and 23,000 deaths each year in the U.S., according to the Centers for Disease Control and Prevention.

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FDA approves CSL Behring’s AFSTYLA for hemophilia A

Tuesday, May 31, 2016

CSL Behring has announced that the FDA has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. AFSTYLA is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing.

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Lack of clinical data overshadows opioid prescribing guidelines

Sunday, May 1, 2016

On March 18, 2016, the Centers for Disease Control (CDC) in Atlanta released its guidelines for prescribing opioids for chronic pain in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care. The results were instantly controversial. While no one argues that opioid addiction has become a health crisis, critics claim that a scarcity of clinical trial data undermine the guidelines and could even lead to patients being harmed.

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Inovio, NIH, Mayo to initiate hepatitis C immunotherapy trial

Thursday, April 28, 2016

Inovio Pharmaceuticals has announced that its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies.

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Revisiting industry partnerships with the Department of Veterans Affairs

Monday, April 4, 2016

Contract research organizations (CROs) should consider partnering with the Department of Veterans Affairs (VA) when conducting clinical trials, according to an attendee at the recent Clinical Trial Collaborations conference in Boston, Massachusetts. “The atmosphere is right for increasing the number of industry-VA collaborations,” said Dawn McKenna, executive director of the Bedford VA Research Corporation in Bedford, Massachusetts. McKenna spent years working in the pharmaceutical research and development industry as well as government and nonprofit areas before taking the helm in Bedford last year.   

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