NIH launches $9.8M neuromodulation competition

The National Institutes of Health (NIH) announced today that it launched the first phase of its Neuromod Prize competition.

Neuromod Prize, a $9.8 million competition, aims to accelerate the development of neuromodulation therapies. NIH seeks scientists, engineers and clinicians to submit novel concepts and clinical development plans to demonstrate solutions for stimulating the peripheral nervous system to treat disease and improve human health.

Get the full story at our sister site, Medical Design & Outsourcing.

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NIH launches $9.8M neuromodulation competition

The National Institutes of Health (NIH) announced today that it launched the first phase of its Neuromod Prize competition.

Neuromod Prize, a $9.8 million competition, aims to accelerate the development of neuromodulation therapies. NIH seeks scientists, engineers and clinicians to submit novel concepts and clinical development plans to demonstrate solutions for stimulating the peripheral nervous system to treat disease and improve human health.

According to a news release, the first phase of the competition will award up to $800,000. NIH plans to launch a second phase awarding up to $4 million, then a third phase awarding up to $5 million, subject to the availability of funds. NIH will launch the second and third phases at a future time.

The Neuromod Prize makes up part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program from the NIH Common Fund. NIH said it hopes to use the competition to bridge the gap between early-stage rese…

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NIH director Francis Collins to step down

The National Institutes of Health (NIH) announced today that Dr. Francis S. Collins will step down as director of the agency.

Collins, the longest-serving presidentially-appointed NIH director, decided to end his tenure by the end of the year. He had served three U.S. presidents over more than 12 years.

NIH did not announce a successor to Collins or a timeline for appointing one.

“It has been an incredible privilege to lead this great agency for more than a decade,” Collins said in a news release. “I love this agency and its people so deeply that the decision to step down was a difficult one, done in close counsel with my wife, Diane Baker, and my family. I am proud of all we’ve accomplished. I fundamentally believe, however, that no single person should serve in the position too long, and that it’s time to bring in a new scientist to lead the NIH into the future.

“I’m most grateful and proud of the NIH staff and the scientific community, wh…

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NIH providing $185M to boost research into how human genome functions

The National Institutes of Health (NIH) announced a plan to provide approximately $185 million over five years to a consortium researching genomic variation.

Initiated and funded by NIH’s National Human Genome Research Institute (NHGRI), the Impact of Genomic Variation on Function (IGVF) consortium will receive the $185 million over five years in the form of 25 awards across 30 U.S. research sites to continue working to understand how genomic variation alters human genome function and influences human health and disease, according to a news release.

NIH said that, by integrating experimental methods with advanced computer models, the IGVF consortium will identify which variants in the genome are relevant for health and disease, producing information that will be of critical importance to clinicians.

All information generated by the consortium will be made freely available to the research community through a web portal to assist with future research…

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NIH to study third dose of COVID-19 vaccine in people with autoimmune disease

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination.

The Phase 2 study will also test the impact of pausing immunosuppressive medication to determine if it improves the antibody response.

The study, titled “COVID‐19 booster vaccine in autoimmune disease non‐responders,” will test an additional dose of vaccines from both Pfizer-BioNTech and Moderna.

The National Institute of Allergy and Infectious Diseases (NIAID), an NIH division, is sponsoring the study.

The study will first focus on people with one of the following autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.

On Aug. 12, FDA authorized an additional dose of Pfizer-BioNTech and Moderna COVID-19 va…

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The pandemic and cumulative disease burden are ‘existential’ threats, experts argue 

Image courtesy of Pixabay

While the pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and addressing the burden of all diseases, Yancopoulos added.

Society needs new strategies for addressing the disease burden. “By the year 2050, there will be 10 to 20 million Americans with Alzheimer’s disease with no treatment,” Yancopoulos said. While Biogen’s (NSDQ:BIIB) recently-approved aducanumab could be the first disease-modifying therapy, it remains unclear if the drug is effective.

Added to the disease burden are growing rates of obesity, diabetes, cancer and heart disease — “not to mention the potential of seeing th…

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NIH launches study of allergic reactions to COVID-19 vaccines

(Image by Sam Moqadam on Unsplash)

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.

Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

The NIH’s National Institute of Allergy and Infectious Diseases is sponsoring and funding the news study, which is enrolling 3,400 adults ages 18 to 69 years at up to 35 academic allergy-research centers nationwide.

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

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NIH launches study of allergic reactions to COVID-19 vaccines

[Image by Sam Moqadam on Unsplash]

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.

Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

Most of the rare, severe allergic reactions to the vaccines took place among people with a history of allergies — many of them with prior experience of having a life-threatening allergic reaction called anaphylaxis. Researchers are still uncertain why there are rare cases of anaphylactic reactions after the Mode…

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NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial.

NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned after information released by the company surrounding the clinical trial for its AZD1222 vaccine may be outdated. In turn, that may have provided an incomplete view of the efficacy data, NIAID said.

“We urge the company to work with the [Data and Safety Monitoring Board (DSMB)] to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” NIAID wrote in the statement.

AstraZeneca yesterday published results from the trial, revealing that the vaccine developed in collaboration with Oxford University was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization.

Buoyed b…

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NIH starts Phase 3 trial of blood clotting treatments for COVID-19

[Photo by Fusion Medical Animation on Unsplash]

The NIH announced today that it has launched the last of three Phase 3 clinical trials to evaluate the safety and effectiveness of blood thinners to prevent life-threatening blood clots in adults diagnosed with COVID-19.

As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial will study the use of Bristol Myers Squibb/Pfizer’s Eliquis blood thinner in patients discharged from the hospital following a case of moderate-to-severe COVID-19. The other two ACTIV studies already underway involve hospitalized COVID-19 patients and people with COVID-19 who have not been hospitalized.

The trials are taking place at more than 100 sites worldwide.

Researchers noticed early in the COVID-19 pandemic that many people who died has blood clots throughout their bodies — clotting that can cause multiple health c…

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NIH halts COVID-19 convalescent plasma trial

[Image courtesy of CDC]

The NIH announced today that it has halted a clinical trial of COVID-19 convalescent plasma among ER patients with mild to moderate symptoms after the trial found no significant benefit from the treatment.

An independent data and safety monitoring board (DSMB) recommended on Feb. 25 that NIH’s stop enrolling new patients. The Clinical Trial of COVID-19 Convalescent Plasma of Outpatients — which had already enrolled 511 participants from 47 hospital emergency departments across the U.S. — found no harm from convalescent plasma. Still, there was no significant difference in hospitalization and death rates among those receiving the plasma and those receiving a placebo.

FDA in August 2020 granted an emergency use authorization (EUA) for investigational convalescent plasma in treating hospitalized COVID-19 patients, noting at the time that the plasma might help some hospitalize…

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What made rapid mRNA COVID-19 vaccine development possible

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed.

But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine virtual event.

The traditional vaccine development process, which typically spans years, was “shortened, but no integrity was lost,” Corbett said.

Scientists at the NIH have studied coronaviruses for several years, said Corbett, who leads a research team there focused on coronavirus vaccines.

One central factor driving the rapid development of mRNA COVID-19 vaccines was the collaboration between laboratories, institutions and companies across the globe.

“And then secondly, there was extensive work on MERS and other …

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