Innovators Get a Green Light from DOJ to Share Information That Could Expedite Future COVID-19 Treatments

Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline  recieved approval from DOJ on July 23, 2020 to share information about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody treatments that are determined to be safe and effective to treat COVID-19.

 

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Patients, Employers, Labs and Health Insurance Providers Call on Congress to Dedicate Funding for COVID-19 Testing to Get America Back to Work and School

WASHINGTON, D.C. – The National Consumers League, the American Clinical Laboratory Association (ACLA) and America’s Health Insurance Plans (AHIP) joined nearly 50 leading stakeholders representing patients, employers, clinical laboratories, health insurance providers and other leaders from across health care community yesterday in sending a letter to congressional leadership requesting dedicated federal funding for the critical testing needed to reopen the country.Continue reading

Pfizer and BioNTech Announce Agreement with U.S. Government for up to 600 Million doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021Continue reading

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

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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

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