COVID Pharma Update

Therapeutics

QuVa Pharma® Announces Availability of Intravenous Dexamethasone to Support Hospitalized COVID-19 Patients
QuVa Pharma, Inc. confirms its ability to provide Dexamethasone Phosphate as a compounded sterile product in a ready-to-administer IV bag, under FDA Drug Shortage guidelines. QuVa Pharma’s Dexamethasone Phosphate is a compounded sterile product (CSP) available as 6 mg in 25 ml 0.9% sodium chloride IV bag and is now available to be ordered.

FDA Approves First Treatment for COVID-19
The U.S. Food and Drug Administration (@US_FDA) approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19
Nitric Oxide Innovations (NOI), LLC has received Investigational New Drug (IND #150758) clearance as part of the Coronavirus Treatment Acceleration Program (CTAP) from the U.S. FDA to begin a Phase 2b/3a outpatient clinical study testing the safety and efficacy of its new drug, NOviricid, 30 mg sodium nitrite dosing in an oral lozenge. NOviricid is the first oral Nitric Oxide (NO) generating drug to be clinically tested to treat African Americans diagnosed with COVID-19.

HHS, DOD Collaborate on Plans to Purchase of Lilly Investigational Therapeutic to Treat COVID-19
As part of the Trump Administration’s goal of delivering life-saving vaccines and therapeutics in record time through Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and Department of Defense announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555.

Vaccines

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
Moderna, Inc. (@moderna_tx), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.

Pfizer Says Early Analysis Shows its Covid-19 Vaccine is More than 90% Effective
Drugmaker Pfizer said Monday an early look at data from its coronavirus vaccine shows it is more than 90% effective — a much better than expected efficacy if the trend continues.

FDA Vaccine Approval Committee Fails to Solicit Public Input Despite Widespread Concerns
According to recent surveys, nearly 50% of Americans say they are unlikely to get a COVID-19 vaccine when it becomes available. The main reasons cited are concerns about potential negative side effects and a lack of trust and transparency in the approval process.

J&J plans to test its COVID-19 vaccine in ages 12-18 soon
Johnson & Johnson (@jnjnews) plans to start testing its experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible, and the company’s previous experience with the same technology in a vaccine successfully used in children could give it a leg up with regulators.

Pfizer to bypass gov’t, use its own network to ship COVID-19 vaccine
U.S. drugmaker Pfizer (@pfizer) will use its own distribution network for its COVID-19 vaccine rather than a going through the U.S. government’s designated coordinator, a company official has said.

AstraZeneca aims to bring non-U.S. vaccine data before the FDA
AstraZeneca (@AstraZeneca) will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.

Facilitating the ‘Vaccine Era’ of COVID-19 Response: ThermoGenesis to Receive U.S. Patent for Breakthrough Serological Test Reader Technology
ThermoGenesis Holdings, Inc. (@ThermoGenesis) announced that it has received notification from the United States Patent and Trademark Office (USPTO) of its intent to issue U.S. Patent No. 10,823,746 on November 3, for the Company’s new breakthrough lateral flow immunoassay test reader technology, the ThermoGenesis Reader. The application leading to this patent, titled, “Lateral Flow Immunoassay Test Reader and Method of Use,” was accepted by USPTO under its recently announced COVID-19 Prioritized Examination Program.

Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccines
To maximize access to COVID-19 vaccines for all Americans, the U.S. Department of Health and Human Services (@hhsgov) announced the U.S. government’s partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains.

Testing

Apollo Medco To Introduce One of the Healthcare Industry’s Most Accurate, Reliable and Quickest COVID-19 Testing Platforms for Businesses, Organizations, Municipalities and Individuals
Apollo Medco (@ApolloMedco), a medical technology solutions company, announced the planned availability of its new rapid lateral flow antigen COVID-19 testing platform starting in November 2020. The “COVID CleanPass by Apollo Medco” system is a mobile app-linked, HIPAA compliant, cloud secure and data-backed COVID-19 testing platform which gives testers the ability to process an unprecedented 200-300 people each hour and report results within 15 minutes utilizing testing kits from Quidel, BD and Abbott.

The Doc Announces New Rapid Detection SARS-CoV-2 Antibody Test Kit, Plans to Alleviate COVID-19 Testing Delays
The Doc, LLC. announced the development of a new rapid detection serological antibody test kit for SARS-CoV-2, the virus that causes COVID-19. With results in minutes using only a drop of blood, the Company’s IgM/IgG antibody test has been submitted for Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The Company has already conducted several rounds of clinical trials with patients in Los Angeles, using antibody testing as an accurate and reliable diagnostic tool.

To Read

The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines – By Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

STAT-Harris Poll: Most Americans won’t get a Covid-19 vaccine unless it cuts risk by half – By Ed Silverman, STAT

‘Like watching a train wreck’: Experts say America is behind on COVID-19 vaccine messaging, call for honest, straight talk – by Elizabeth Weise, USA TODAY

To Listen

COVID-19 Episodes
We have compiled a playlist from all our shows and podcasts on our network that discuss the current COVID-19 pandemic.

COVID-19 Resources

HealthcareNOW Radio rounded up some health IT resources being offered by companies to help healthcare professionals, American citizens and all of those affected in the fight against the coronavirus.