NIH Archives - Medical Design Sourcing

Pharma giants make progress in pivot to mRNA technology in race for next-gen influenza vaccines, but hurdles remain

[Image courtesy of Adobe Stock]

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But with demand for COVID-19 vaccines cooling, drug developers are aiming to extend the dominion of mRNA technology to flu vaccines. This month, Moderna and the CureVac/GSK alliance announced promising interim results for their respective flu vaccine candidates. Meanwhile, a year ago, in September 2022, Pfizer announced a phase 3 study for its mRNA-based influenza vaccine. NIH is also developing an mRNA vaccine that promises to provide protection against all known influenza subtypes. A phase 1 study of it is underway.

Sanofi has acknowledged the promise and perils of mRNA flu vaccines

Sanofi, a prominent flu vaccine maker, has acknowledge…

Researchers develop wearable monitor that measures ECG and SCG signals simultaneously

A researcher examines the health monitor part of the wearable device under a microscope in Yan’s lab. [Image courtesy of Pate McCuien/University of Missouri]

Researchers at the University of Missouri received a $2.6 million grant from the NIH to develop a multifunctional, wearable heart monitor.

Funding helps the researchers create a breathable material with antibacterial and antiviral properties. This supports their ongoing development of the heart monitor.

According to a post on the university’s website, they designed the device to continuously track human heart health. It does so by monitoring dual signals simultaneously. Its electrocardiogram (ECG) function measures the heart’s electrical signal while a seismocardiogram (SCG) measures vibrations. After the recording on an electronic device, users can share their information with their healthcare provider to identify potential warnin…

NIH funds Illinois Tech project using machine learning to fully automate insulin delivery

[Image courtesy of Illinois Tech]Researchers at Illinois Tech received $1.2 million from the NIH to develop a machine learning system for an artificial pancreas’ insulin delivery.

Professor of chemical engineering Ali Cinar leads the project aimed at easing the burden on those with type 1 diabetes. NIH funding covers for years for developing the machine learning system. The researchers aim to integrate it into Cinar’s artificial pancreas system to enhance accuracy.

Get the full story at our sister site, Drug Delivery Business News.

Rescue Biomedical wins $2.8M grant for nalaxone-releasing implant for opioid overdoses

[Photo courtesy of Purdue/Rescue Biomedical/Hugh Lee]Rescue Biomedical announced today that it received a $2.8 million grant from the National Institutes of Health for its opioid overdose treatment.

West Lafayette, Indiana received a Fast-Track Small Business Innovation Research, or SBIR, grant from the NIH. The company develops technology that detects when a person is overdosing on an opioid and delivers naloxone to reverse the action.

The minimally invasive, subcutaneous device presents a closed-loop drug delivery system. Hyowon “Hugh” Lee, Rescue Biomedical CEO, said the company seeks to partner with recovery clinics and clinicians. This way, they can identify and work with opioid use disorder (OUD) patients at high risk of overdosing again.

Get the full story at our sister site, Drug Delivery Business News.

U.S. government launches CP-RND, a public-private partnership for rare neurodegenerative diseases

The FDA and NIH have debuted the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a public-private partnership focused on developing new therapies for amyotrophic lateral sclerosis (ALS) and rare neurodegenerative diseases.

One of the goals of the CP-RND is to foster innovation in drug discovery and development as well as clinical testing. In addition, CP-RND will aim to develop a therapy that halts the progression of ALS.

In a similar vein, FDA launched its Action Plan for Rare Neurodegenerative Diseases in June, including amyotrophic lateral sclerosis (ALS).

FDA and NIH have chosen Tucson, Arizona-based Critical Path Institute (C-Path) to help guide the CP-RND initiative.

Founded in 2005 as a public-private partnership, C-Path is an independent, nonprofit organization.

Earlier this year, C-Path established Amsterdam as the head of its European operations.

In its work on the CP-RND project, C-Path will gather experts in r…

FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

New method of cardiac ablation used in first in-human trial for ventricular tachycardia

Thermedical’s Durablate catheter [Photo courtesy of Thermedical]

A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic.

The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline at the same time as the RF energy is applied increases heat transfer compared to conventional methods of ablation, which means the ablation can treat tissue deeper in the heart wall than the surface.

Caused by irregular electrical signals in the lower chambers of the heart, VT can trigger heartbeats so rapid that the heart’s chambers don’t fill with blood properly. VT can also stop the heart entirely. Implantable cardioverter-defib…

NIH research backs efficacy of AREDS2 formula in macular degeneration

The National Institutes of Health (NIH) has released a new report analyzing a decade of data related to AREDS2, a vitamin and mineral supplement with lutein, vitamin C, zeaxanthin, zinc and vitamin E.

AREDS2, whose name refers to the second formulation of a supplement used in Age-Related Eye Disease Studies, can slow the progression of age-related macular degeneration.

The AREDS2 formulation replaces the beta-carotene in the original formulation with the carotenoids lutein and zeaxanthin.

NIH decided to move away from beta-carotene after observing an increased risk of lung cancer in smokers in earlier NIH-backed research. “Our goal with AREDS2 was to create an equally effective supplement formula that could be used by anyone, whether or not they smoke,” said Dr. Emily Chew, director of the Division of Epidemiology and Clinical Application at the National Eye Institute (NEI). “This 10-year data confirms that not only is the new formula safer, it’s actuall…

U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health.

HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy director, effective next month.

Russell currently serves as chief scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS). He previously spent more than 10 years as a program manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA).

At Darpa, Russell focused on new experimental platforms and tools to facilitate discovery, quantification and “big validation” of fundamental measures in social science, behavioral science and human performance, accordin…

NIH licenses COVID-19 research technologies to WHO initiative

The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP).

Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics.

In total, NIH is providing 11 COVID-19 technologies under two licenses, bringing the number of technologies licenses to MPP to the following 14 items:

A VSV-EBOV-based vaccine candidate. This SARS-CoV-2 vaccine candidate is based on a modified approved Ebola vaccine known as Ervebo from Merck & Co. ACE2 Dimer construct (Research tool for drug development). This technology is a plasmid encoding human ACE2 dimers, which refers to two conjoined copies of ACE2. ACE2 is a protein involved in COVID-19 infections. NIH notes that the research tool can help isolate antibodies generated against SARS-CoV-2. …

NIH to launch clinical trial of three mRNA HIV vaccines

HIV-infected cell. Image courtesy of NIAID

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences.

The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA.

Get the full story from our sister site, Drug Discovery & Development.

NIH to launch clinical trial of three mRNA HIV vaccines

HIV virus image courtesy of NIAID

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences.

The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA.

The three HIV vaccine candidates were developed by scientists at the Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD) and the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center at Scripps.

NIAID is a division within the National Institutes of Health (NIH).

Moderna (Nasdaq: MRNA) manufactured the vaccines for the HVTN 302 trial with an NIAID-backed contract.

Similar to mRNA-based COVID-19 vaccines, each of the HIV vaccine candidates will be based on the spike protein found on the surface of the vir…