OPEN INVITATION FOR TOURS – 850 N 5TH STREET INNOVATION CENTER BY WEXFORD SCIENCE + TECHNOLOGYContinue reading
Author Archive: AZBio
Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
- First interim analysis included 95 participants with confirmed cases of COVID-19
- Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)
Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 monthsContinue reading
Managing the microbiome raises new hope for autism
In new research appearing in the journal mSphere, Rosa Krajmalnik-Brown, James Adams and their colleagues highlight the crucial importance of bacterial microbes in the human gut for the diagnosis and treatment of ASD.
In September of 2020, Rosa Krajmalnik-Brown was honored as the Arizona Bioscience Researcher of the Year
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GT Medical Technologies Announces First Patient Treated in Registry Trial of GammaTile Therapy for Brain Tumors
- Study to Enroll 600 Patients and Evaluate Real-World Clinical and Patient Reported Outcomes Across All Brain Tumor Types
- First Patient Enrolled by Vidant Health in Greenville, N.C.
Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19
- Bamlanivimab is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients
- U.S. government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication
Brain State Technologies® and Cereset® Announces Promotion of Russell Scholl to President and Chief Financial Officer
The company’s CFO has been instrumental to the company’s success.Continue reading
What Comes Next as Election Week Draws to a Close
The 2020 Election Cycle has been historic and unique in many ways. As the sun rises on the 6th day after Election Day, here are some updates and resources to help you stay in the loop on what comes next.Continue reading
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study
- Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status
PHOENIX–(BUSINESS WIRE)–NeuroEM Therapeutics is poised to deliver a knockout blow to Alzheimer’s disease. The clinical-stage medical device company is pleased to announce FDA Breakthrough Device designation for its bioengineered head device shown to reverse Alzheimer’s memory loss in its pilot study, published last fall in the Journal of Alzheimer’s Disease.
“No other drug or device has received this highest FDA designation to accelerate a treatment for Alzheimer’s disease,” said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. “No other treatment has demonstrated the clinical results we have thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”Continue reading
BIO’s Dr. Michelle McMurry-Heath Congratulates President-Elect Biden & Other Newly Elected Leaders of Both Parties Who Won
Statement from Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO)Continue reading