Anti-viral antibody cocktail REGN-COV2 is also in Phase 2/3 treatment trials following positive Phase 1 safety reviewContinue reading
Category Archives: AZBio News
TGen Teams with Poba Medica to Produce 10,000 COVID-19 Test Kits per Month
Poba Medical’s cleanroom assembly line helps TGen provide coronavirus tests for some of Arizona’s most vulnerable and underserved populationsContinue reading
MCC serves as COVID-19 drive-thru testing site
MESA, Arizona — July 1, 2020 – Mesa Community College serves as a location for drive-thru COVID-19 testing in alignment with Governor Ducey’s enhanced COVID-19 Action Plan (6/17/20). Embry Women’s Health, a local testing provider, along with the Arizona National Guard, will operate testing stations in the East Parking Lot (Lot C) of the college campus located at 1833 W. Southern Ave. Individuals arriving for appointments should enter at Enrollment Way off Southern Ave.Continue reading
Pfizer and BioNTech Announce Early Positive Data from Ongiing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-COV-2
- In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
- At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2.
- At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
- Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
- Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
- Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021
New US Patent Protects Key Element of First-in-Class Prodrug Candidate for Triple Negative Breast Cancer
Tumor-targeting and tumor-penetrating peptide enables EnduRx Pharmaceuticals novel prodrug for triple-negative breast cancerContinue reading
Governor Ducey Takes Further Action To Reverse COVID-19 Spread In Arizona
Large Gatherings Suspended; Bars, Gyms, Movie Theaters, Waterparks and Tubing Rentals Must Pause Operations; School Restart DelayedContinue reading
Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis
Company seeks accelerated approval for cancer drug
TUCSON, Arizona, June 29, 2020 – Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).Continue reading
Gilead Announces Pricing for Remdesivir in Open Letter
According to Daniel O’Day, Chairman & CEO, Gilead Sciences, “In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.”
FDA Approves First-Of-Its-Kind Percept™ PC Neurostimulator with BrainSense™ Technology
Next-Generation Technology Makes Percept™ the First and Only DBS System with Ability to Capture Patient-Specific Brain Signals
for More Personalized, Data-Driven TreatmentContinue reading
Dr. Joann Sweasy Named Director of University of Arizona Cancer Center
Dr. Sweasy will serve as director of the only Arizona-based National Cancer Institute-designated Comprehensive Cancer Center, as well as UArizona’s chief adviser on cancer-related matters and principal investigator of the NCI Cancer Center Support Grant.Continue reading