Hologic wins FDA clearance for COVID-flu-RSV assay

Tge Panther Fusion SARS-CoV-2/Flu A/B/RSV assay [Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV.

“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” Hologic Diagnostic Solutions President Jennifer Schneiders said in a news release.

“While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season, and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine…

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FDA’s mandatory medical device shortage reporting ends

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

Reporting of medical device shortages to the FDA is no longer mandatory with last week’s expiration of the COVID-19 public health emergency.

Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing deviceshortages@fda.hhs.gov.

“The FDA encourages device…

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FDA authorization of vilobelimab signals new opportunities for drug developers in inflammatory diseases

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10.

The EUA represents a significant advance for the Jena, Germany–based company, which on March 31, 2022, encountered a setback related to the antibody. At that time, the company announced that vilobelimab failed a topline readout for critically ill intubated patients suffering from COVID-induced pneumonia in the phase 2/3 PANAMO study. Later, however, InflaRx reported in a predefined analysis without site-stratification that vilobelimab significantly decreased all-cause mortality at 28 days. While the initial protocol did not require site-stratification, the company amended the protocol based on regulators’ recommendations.

Regulatory nod for vilobelimab could spark new developments …
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Pharmacovigilance in personalized medicine: Adapting to a new era of drug development

[Image courtesy of LeoWolfert via iStock]

One of the ways that the COVID-19 pandemic had a profound impact on the pharma industry was how it highlighted the importance of pharmacovigilance. As personalized medicine gained traction, drug developers had to evolve their strategies to ensure safety and efficacy. In their report, “The Future of Pharmacovigilance,” Dr. Sabine Jeck-Thole and Ben Enejo, partners at Arthur D. Little, discussed the challenges and opportunities in this new landscape.

Embracing the shift in perception of adverse events and side effects

“When we heard about adverse events and side effects, it was not bad news,” Jeck-Thole said in an interview. “It indicated that we understood our drug or vaccine much better than without any safety information.” She emphasized that this shift in perception was essential for the industry as it moved towards pharmacovigilance in personal…

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Pfizer and BioNTech secure FDA nod for omicron-adapted COVID-19 booster for kids under 5

COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age.

The booster can be administered at least two months after completing the primary vaccination series with three doses of the original Pfizer-BioNTech COVID-19 vaccine. Additionally, FDA has authorized the bivalent vaccine for use as the third dose in a primary series for the same age group. The agency, however, has not yet authorized a fourth booster dose.

Trial data Supports bivalent vaccine safety and efficacy

The EUA is based on data from substudies within the companies’ Phase 1/2/3 trial (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth bivalent vaccine dose in 300 children aged 6 months to 4 years. A subset of 60 study participants within the same age group demonst…

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Glowing nanoparticles enhance at-home COVID-19 test sensitivity

This glowing star inspired glow-in-the-dark COVID-19 testing technology developed by Richard Willson and his team at the University of Houston. [Image courtesy of the University of Houston)

Researchers at the University of Houston are using glow-in-the-dark materials to enhance the sensitivity of rapid COVID-19 home diagnostics.

The widely used lateral flow assay provides rapid results for diagnostics such as at-home COVID-19 or pregnancy tests. They also offer low costs and ease of operation. Test results on LFA diagnostics come through in colored lines.

“We are making those lines glow-in-the-dark so that they are more detectable, so the sensitivity of the test is better,” said Richard Willson, who’s leading the University of Houston team. 

Willson is the Huffington-Woestemeyer professor of chemical and biomolecular engineering at the UH Drug Discovery Institute and a professor of biochemic…

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This T-cell vaccine could be the future of COVID-19 protection

[Image courtesy of Production Perig/Adobe Stock]

The current mRNA vaccines from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) stimulate the production of neutralizing antibodies that bind to the spike protein of SARS-CoV-2.

But there is a novel mRNA vaccine that activates T cells to attack cells infected with the virus. Developed by researchers at MIT and other institutions, the new vaccine could sidestep the need for updated boosters based on currently circulating variants.

In a preclinical study published in Frontiers in Immunology, the T-cell vaccine successfully attacked cells infected with the virus rather than activating the part of the immune system that releases neutralizing antibodies. In addition, the researchers tested the vaccine in humanized mice and successfully generated both CD8+ (cytotoxic) and CD4+ (helper) T-cell responses.

This new MIT-T-COVID vaccine could …

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How the BD diagnostics business is driving greater access to care

The BD Max system. [Image courtesy of BD] It’s been a busy time for BD, with recent approvals further driving the company’s diagnostics business forward.

Dave Hickey and BD (NYSE:BDX) have their sights on what they call “transformative forces.” These forces could change the delivery of healthcare going forward.

Hickey, EVP and president of the Life Sciences segment at BD, said these forces include smart connected care, migration to new care settings and improving chronic disease outcomes.

Digitization and automation, plus point-of-care and at-home testing, comprise these areas. That’s where BD’s focus lies.

“Our innovation strategy and our investment dollars are going into those areas,” Hickey told MassDevice.

Recent news along these lines includes the February FDA emergency use authorization (EUA) for BD’s COVID-19, flu and RSV combination diagnostic. Just weeks later, the company received app…

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COVID-19’s mechanisms are becoming clearer, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]

We still don’t fully understand why the SARS-CoV-2 virus is so transmissible and causes severe disease in some people but not others.

But Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business, said he’s amazed by how quickly we’re learning about COVID-19, building off our prior knowledge of coronaviruses and other viral pathogens.

“We have more of a handle on the mechanisms, and that’s where I think we are beginning to have hope for clarity,” he said. “In just about every disease that we are able to treat, we develop those treatments because we understand the fundamental mechanism of the disease.”

Adamson warned of increasing rates of heart and lung failure due to COVID-19 when Medical Design & Outsourcing interviewed h…

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Dual defense: FluGen’s M2SR vaccine shields against influenza and COVID-19

[Image courtesy of Adobe Stock]

For many years, vaccine developers have known that several problems with current influenza vaccines – short-lived serum antibodies, lack of immunity at the site of infection, and lack of robust protection against drifted strains – contribute to their modest efficacy. Although new approaches to influenza vaccine design, manufacture and administration have been explored, none has yielded an approved vaccine that addresses all of these problems.

mRNA COVID-19 vaccines have saved millions of lives worldwide since their approval, and their importance in combatting the pandemic cannot be overemphasized. However, these vaccines are already facing the same problems as influenza vaccines. Because they protect against illness but not infection, vaccinated individuals who contract the SARS-CoV-2 virus can still shed and transmit it. 

To better control both viruses and the illnesses th…

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FDA extends shelf life of some popular COVID tests

[Image courtesy of Abbott]The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life.

Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates.

The Abbott BinaxNow COVID-19 antigen self tests now have a shelf life of 22 months. Previously, the popular test had a 15-month shelf life.

Maxim Biomedical’s ClearDetect COVID-19 antigen home test initially received authorization with an eight-month shelf life. The FDA announced that it extended the shelf life of that test to 12 months.

iHealth Labs COVID-19 antigen rapid tests received a three-month extension from 12 months to 15 months.

“The expiration dates for these tests have been extended to reflect the longer shelf-life,” the FDA said in a notice. The agency based its extension on additional data provided by the manufacturers. This data demons…

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3D-printed nasal swab wins Patents for Humanity award

The 3D-printed swab team helped solve a global shortage, sharing their design for free with organizations that produced more than 100 million swabs. [Image courtesy of USF]

The University of South Florida received the Patents for Humanity award for its patent of a 3D-printed nasopharyngeal swab.

Developers created the swab in the early part of the COVID-19 pandemic to solve production disruptions during a time of critical need for COVID-19 testing.

The U.S. Patent and Trademark Office (USPTO) awarded USF with the Patents for Humanity prize. Other recipients of awards include the National Institute of Allergy and Infectious Diseases of the NIH, Regeneron Pharmaceuticals, Gilead Sciences Inc., and Caron Products. The USPTO plans to celebrate the winners at an awards ceremony on Feb. 16, 2023.

Due to the urgent global need for swabs, USF’s team decided to forgo monetization of its invention, th…

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