New Breakthrough Test Detects and Predicts Severity of COVID-19

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AMPEL BioSolutions today announced a breakthrough in precision and personalized medicine that can detect and predict the severity of COVID-19 in patients while also determining the best treatment options for each specific case. The company’s new approach, through a simple blood test, will ultimately accelerate the means of providing effective treatments to the right people at the right time and potentially stem the serious illness caused by SARS-CoV-2 infection that can lead to lung damage or death.

How the American Gene Technologies® COVID-19 Lab Could Help Cure HIV

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In response to the COVID-19 pandemic, AGT™ CEO Jeff Galvin decided to turn “lemons into lemonade” by creating a COVID-19 testing lab. This new testing lab provided security for the in-person staff running experiments in the company’s research lab while also generating more than $10M in funding for its HIV cure program.

FDA Authorizes Novavax COVID Vaccine for Adults

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FDA authorizes Novavax Covid vaccine for adults as the first new shots in U.S. in more than a year
Spencer Kimball
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FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.
The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA.
Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed.
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In this photo illustration the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vials.
Pavlo Gonchar | LightRocket | Getty Images
The Food and Drug Administration has authorized Novavax’s two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began.

FDA Advisors Vote 21-0, with One Abstention, to Authorize Novavax’s Covid-19 Vaccine to be the Fourth US Option

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A pan­el of FDA’s out­side ex­perts rec­om­mend­ed 21 to 0, with one mem­ber ab­stain­ing, that the agency give emer­gency use au­tho­riza­tion for No­vavax’s two-dose Covid-19 vac­cine for peo­ple aged 18 years and old­er.
The ad­vi­sors’ vote of con­fi­dence was de­liv­ered days af­ter the FDA’s sci­en­tists de­ter­mined the vac­cine to be ef­fec­tive but with the caveat of po­ten­tial rare heart in­flam­ma­tion. Last au­tumn, pre-Omi­cron, the vac­cine was found to have a 90.4% ef­fi­ca­cy in a tri­al com­pris­ing 17,272 peo­ple giv­en a vac­cine and 8,385 peo­ple giv­en a place­bo.
“The Ad­vi­so­ry Com­mit­tee’s pos­i­tive rec­om­men­da­tion ac­knowl­edges the strength of our da­ta and the im­por­tance of a pro­tein-based COVID-19 vac­cine de­vel­oped us­ing an in­no­v­a­tive ap­proach to tra­di­tion­al vac­cine tech­nol­o­gy,” CEO Stan­ley Er­ck said in a state­ment. “We have heard in to­day’s VRB­PAC meet­ing the sig­nif­i­cant sup­port for our vac­cine from physi­cians, health­care or­ga­ni­za­tions, and con­sumers who are ea­ger­ly an­tic­i­pat­ing a pro­tein-based vac­cine op­tion. We look for­ward to the FDA de­ci­sion.”

Diagnostic startup Senzo is developing an at-home COVID-19 test that’s as reliable as a PCR

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Diagnostic startup Senzo is developing an at-home COVID-19 test that’s as reliable as a PCR
Following a promising early study, the company hopes to take the product to market before the end of the year and add some Philly-based team members. By Paige Gross / STAFF
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Senzo’s Amplified Lateral Flow COVID-19 test.
(Courtesy photo)
If you’ve headed to a work event, family gathering or crowded space in the last two years, it’s likely you’ve taken an at-home COVID-19 test to check your viral status.
It’s how much of the world is responsibly operating in the “new normal” right now, as we manage the ongoing pandemic while returning to something like pre-2020 life. And one Philly-area startup is hoping its tests can be a part of that system.
Senzo, a point-of-care and self-testing diagnostics company, announced this week it received 100% accuracy ratings of its Amplified…

Ellume’s COVID-19 Home Test Automatically Reports Depersonalized Test Results to HHS and State Health Departments to Better Track Virus Spread 

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With the rise of at-home testing and a recent increase of COVID-19 cases across the United States, public health officials have expressed concern about an undercounting of cases and a lack of data that may hamper America’s pandemic response. Digital diagnostics company Ellume is today highlighting its COVID-19 Home Test’s automatic reporting function that enables test results to be securely shared with the Department of Health and Human Services (HHS) and State Health Departments – allowing for real-time insights into pandemic trends. The resulting data is deidentified and encrypted to protect consumer identity and privacy. 

Initial Results from Novavax’ COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

Novavax logo
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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.

Ellume Celebrates Grand Opening of First American Facility in Frederick, MD

Photo of Ellume's facility in Frederick, MD
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Governor Larry Hogan joined dozens of attendees at Ellume’s grand opening in Frederick on March 31 to welcome the diagnostics manufacturer to Frederick County. Ellume’s 215,000-square-foot production facility on Executive Way has been up and running since February 2022, only ten months after the company signed a lease with Matan Properties. 

Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents ≥12 to <18 in India

Novavax logo
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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India. The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax™ and is the first protein-based vaccine authorized for use in this age group in India.

NRx Aims to Bring Zyesami to Market Based on Real-World Data in Treating Seriously Ill COVID-19 Patients

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For Jonathan Javitt, Chief Executive Officer of NRx Pharmaceuticals, the company’s experimental COVID-19 treatment aviptadil, which will be known by the trade named Zyesami, can play a key role in saving the lives of those patients who are seriously ill and have failed to respond to Gilead Sciences’ antiviral drug, Remdesivir.