Lifeboat Foundation

Real-world data (and real-world evidence) can also play roles outside of public health emergencies like Covid and monkeypox. They can help determine the long-term effectiveness of many treatments, especially those subject to the expedited approval process, such as those used for rare diseases, and can help determine the value of drugs in general. In many cases, clinical trials are not enough to understand how well drugs really work. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, has said that the clinical trial system is “broken” and that more use of real-world evidence could be an effective addition to the approval process.

The FDA has been taking steps toward using more real-world data outside of public health emergencies like Covid and monkeypox. In 2018, the agency issued guidance for use of such evidence in approving drugs. By 2021, when the FDA issued enhanced guidance on the topic, real-world evidence had been used in approving 90 medical devices and the new use of a drug, Prograf. But this is not happening enough in practice.

Failing to use real-world data means missing out not just on better understanding of the effectiveness of individual drugs but also on a chance to improve the entire pharmaceutical sector, including addressing issues like rising costs. The availability of more data on real-world outcomes from using drugs, especially gene therapies and other innovative and often very expensive treatments, would pave the way for pricing to take patient outcomes into account through approaches like value-based contracting, when health insurers base drug prices on how well drugs work in the people who take them, rather than just in premarket clinical trials.

Summary: Pain-sensing neurons in the put secrete substance P, a molecule that protects against gut inflammation and tissue damage by boosting specific microbes in the gut. In people with inflammatory bowel disease, the pain-sensing neurons are diminished and there are significant disruptions in pain-signaling genes.

Source: Weill Cornell University.

Neurons that sense pain protect the gut from inflammation and associated tissue damage by regulating the microbial community living in the intestines, according to a study from researchers at Weill Cornell Medicine.

Inspired by the way termites build their nests, scientists at the California Institute of Technology (Caltech) developed a framework to design new materials that mimic the fundamental rules hidden in nature’s growth patterns. The researchers demonstrated that by using these rules, it is possible to create materials designed with specific programmable properties.

The research was published in the journal Science on August 26. It was led by Chiara Daraio, G. Bradford Jones Professor of Mechanical Engineering and Applied Physics and Heritage Medical Research Institute Investigator.

“Termites are only a few millimeters in length, but their nests can stand as high as 4 meters—the equivalent of a human constructing a house the height of California’s Mount Whitney,” says Daraio. If you peer inside a termite nest you will see a network of asymmetrical, interconnected structures, similar to the interior of a sponge or a loaf of bread. Made of sand grains, dirt, dust, saliva, and dung, this disordered, irregular structure appears arbitrary. However, a termite nest is specifically optimized for stability and ventilation.

Given the complexity of the human body, it’s no surprise that we’re still making new discoveries about the different parts we’re made up of – and scientists have just made a new discovery about the cerebellum at the back of the brain.

Already known as being important for properly controlling our movements, it now appears that this brain region also has a key role to play when it comes to remembering positive and negative emotional experiences.

These types of emotional experiences are particularly well remembered by the brain, not least because it helps the survival of our species to be able to remember times when we were in danger and times when we prospered.

Human brain tissue has been successfully transplanted into the brains of rats using a cutting-edge experimental procedure, say researchers. They envision the achievement as a promising new frontier in medical research.

Groups of living human nerve cells have become integrated into the brains of laboratory rats, creating hybrid brain circuits that can be activated through input from the rats’ senses, the scientists reported Wednesday.

Further, experiments have shown that the human tissue forms a two-way connection within the rat brain, also sending out signals that can potentially alter the rat’s behavior, the researchers said.

Last year, the pharmaceutical company Biogen released a drug called Aduhelm. It was the first new Alzheimer’s drug approved by the FDA in almost 20 years, but its rollout was mired in controversy — vast swaths of experts decried its approval, claiming there simply wasn’t enough evidence to support its efficacy, while the Journal of American Medicine (JAMA) rejected Biogen’s key Aduhelm paper. Shortly thereafter, Medicare chose to limit coverage of the drug.

All that is to say that given last year’s Aduhelm spectacle, you’d be forgiven for doubting what appears to be a promising development in Biogen’s continued Alzheimer’s drug development. And that’s just what it announced with a collaborator, fellow pharmaceutical maker Eisai, on Tuesday. But that being said, initial data suggests that the new drug is actually proving quite successful in late-stage clinical trials — enough so that Biogen might have a redemption arc, after all.

That new drug, lecanemab, is an anti-amyloid medication. An amyloid is a type of protein, and a normal one for brains to produce. An overabundance of amyloids, however, is believed to be caused by a disruption in a healthy brain’s built-in protein disposal system, resulting in a plaque; although our understanding is still fuzzy, brains with Alzheimer’s are shown to have abnormal plaque levels, so the idea is that anti-amyloid lecenameb, administered intravenously, could scrub that plaque away.

Rates of anxiety and depression have been increasing around the world for decades, a trend that has been sharply exacerbated by the COVID-19 pandemic. New research led by the Boyce Thompson Institute’s Frank Schroeder could ultimately lead to new therapeutics to help relieve this global mental health burden.

First discovered in the 1930s, serotonin is a neurotransmitter produced in many animals that mediates myriad behaviors, such as feeding, sleep, mood and cognition. Drugs that alter serotonin levels are the main weapon to treat psychological conditions like anxiety and depression, as well as eating disorders.

As a simple model for neurobiology research, the microscopic roundworm Caenorhabditis elegans has been used extensively to study serotonin’s role in regulating behavior and food intake. For many years, researchers thought that serotonin was made in C. elegans by one specific molecular pathway, and that serotonin was then quickly degraded. Schroeder’s team and colleagues at Columbia University now demonstrated that both of those assumptions were not quite correct.

What is limb regeneration and what species possess it? How is it achieved? What does this tell us about intelligence in biological systems and how could this information be exploited to develop human therapeutics? Well, in this video, we discuss many of these topics with Dr Michael Levin, Principal Investigator at Tufts University, whose lab studies anatomical and behavioural decision-making at multiple scales of biological, artificial, and hybrid systems.

Find Michael on Twitter — https://twitter.com/drmichaellevin.

Continue reading “Regeneration, Intelligence in Life & Memory — Dr Michael Levin” »

VINS Bioproducts Limited, Hyderabad in collaboration with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH), announced the successful completion of Phase 2 clinical trials of VINCOV-19, India’s first antidote and cure against SARS-CoV-2 virus.

VINCOV-19 is now ready for market authorisation and for simultaneous Phase 3 clinical trials.

Continue reading “VINCOV-19, an antidote, and a cure against COVID-19 completes Phase 2 clinical trials” »