Novartis launches first-of-its-kind not-for-profit portfolio of medicines for symptomatic treatment of COVID-19

  • Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division addresses urgent unmet needs of low- and lower-middle-income countries to treat patients with COVID-19 symptoms
  • Portfolio will be sold at zero-profit to governments in up to 791 eligible countries during the pandemic and until a vaccine or curative treatment is available
  • Early access to treatment for managing  COVID-19 symptoms is critical to preventing healthcare system overload

Continue reading

Pfizer and BioNTech granted FDA Fast Track Designation for Two Investigation mRNA based Vaccine Candidates Against SARS-COV-2

Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA). BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.Continue reading

BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing

  • Simple new assay leverages more than 25,000 BD Veritor™ instruments already used across the U.S. to immediately increase access to COVID-19 testing in frontline health care settings
  • BD will begin shipping the new test this week and expects to ramp-up manufacturing capacity to 2 million tests per week by the end of September
  • This is the company’s third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19

Continue 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

Continue reading