New Alzheimer’s Vaccine To Get FDA Fast-Track Approval Process

Dallas Morning News: Vaxxinity Vaccine To Treat Alzheimer’s Wins FDA Fast-Track Designation
It’s been a promising month for Vaxxinity, the Dallas biotech company testing a new wave of vaccines to treat chronic diseases. The company announced Monday its vaccine candidate to treat Alzheimer’s disease, called UB-311, received fast-track designation from the Food and Drug Administration that will expedite the review process through more frequent discussions between Vaxxinity and the federal regulatory agency. (Wolf, 5/2)

Stat: FDA Suspends Early Study Of Vertex Stem-Cell Therapy For Type 1 Diabetes
Vertex Pharmaceuticals said Monday that the Food and Drug Administration had suspended an early-stage clinical trial of its stem-cell therapy for type 1 diabetes, citing “insufficient information” to support an increase in dosing. The FDA’s decision to place a clinical hold on the diabetes therapy, called VX-880, was a “surprise,” Vertex Chief Operating Officer Stuart Arbuckle told STAT. The company and the study’s independent monitors recently reviewed data from the VX-880 study, concluding that there were no safety or efficacy issues to preclude advancing from a half dose to a full dose of the therapy. “At this point, we don’t know exactly what precipitated the FDA’s decision to place the clinical hold, but we’re confident that we can work with them quickly to move the program forward,” said Arbuckle. (Feuerstein, 5/2)

Reuters: U.S. FDA Declines To Approve Two More China-Tested Drugs
The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies - Hutchmed Ltd (0013.HK) - needs to test its drug for the U.S. population in a diverse multi-regional trial. This is the second time the U.S. regulator has declined to approve a drug that was tested mainly in China. In March, it declined to approve Eli Lilly (LLY.N) and partner Innovent Biologics Inc's (1801.HK) lung cancer drug that had been studied only in China. (5/2)

In other news —

Stat: Guardant Health Launches Early-Detection Test For Colon Cancer 
Bay Area biotech Guardant Health announced the commercial launch of its early-detection colon cancer test on Monday, marking the latest twist in an escalating race to spot cancer sooner and more accurately. The company’s test, known as Shield, is available to adults 45 and older who aren’t up to date with current screening guidelines, don’t have symptoms, and are at average risk of colon cancer. Shield is a lab-developed test, meaning that it hasn’t been approved by the Food and Drug Administration and that each sample (about a tablespoon of blood) must be sent to Guardant’s lab. (Wosen, 5/2)

CIDRAP: Flu Vaccination Associated With 34% Lower Risk Of Cardiac Events
A new meta-analysis of six randomized controlled trials finds that seasonal influenza vaccination was associated with a 34% lower risk of major adverse cardiovascular events, and people with a recent acute coronary event had a 45% lower risk. The study also appeared in JAMA Network Open. The studies took place from 2000 to 2021 and included participants who were randomized to receive either a flu vaccine or placebo. The studies included 9,001 patients at an average age of 65.5 years; 52.3% had a previous cardiac event. (5/2)

The New York Times: Deadly Venom From Spiders And Snakes May Also Cure What Ails You
Efforts to tease apart the vast swarm of proteins in venom — a field called venomics — have burgeoned in recent years, and the growing catalog of compounds has led to a number of drug discoveries. As the components of these natural toxins continue to be assayed by evolving technologies, the number of promising molecules is also growing. “A century ago we thought venom had three or four components, and now we know just one type of venom can have thousands,” said Leslie V. Boyer, a professor emeritus of pathology at the University of Arizona. “Things are accelerating because a small number of very good laboratories have been pumping out information that everyone else can now use to make discoveries.” (Robbins, 5/3)

Stat: Mouse Study: Brain ‘Learns’ To Have Seizures More Efficiently And Frequently
Calculus. Ballroom dancing. The words to your favorite song. There’s practically no limit to what your brain can learn. But a new study suggests that the same process that allows you to hold onto new information and skills could also make certain neurological diseases worse. Scientists found that mice and rats that suffered from seizures commonly seen in people with epilepsy developed changes in the wiring of their brains that advanced the disease. A closer look showed that the cementing of these signals was driven by a process that also supports learning, memory, and attention. (Wosen, 5/2)

CIDRAP: Follow-Up Blood Cultures Tied To Longer Hospital Stays, Antibiotic Duration
In a study published late last week in the same journal, researchers found that follow-up blood culture (FUBC) practices for gram-negative bacilli (GNB) bacteremia were associated with prolonged length of hospital stay and duration of antibiotic treatment. To evaluate the value of routine FUBC for GNB bacteremia, which has been questioned because of the increased risk of false-positive results, researchers conducted a retrospective observational study at four acute-care hospitals in New York City, comparing length of hospital stay, antibiotic duration, and in-hospital mortality in patients with GNB bacteremia who had FUBCs performed and those who didn't. Of the 376 hospitalized patients with GNB bacteremia who met eligibility, 271 (72%) had FUBCs performed. (5/2)

CNN: 7 Hours May Be The Ideal Amount Of Sleep Starting In Middle Age 
The optimum amount of sleep is not too little but not too much -- at least in middle and old age. New research has found that around seven hours of sleep is the ideal night's rest, with insufficient and excessive sleep associated with a reduced ability to pay attention, remember and learn new things, solve problems and make decisions. Seven hours of slumber was also found to be linked with better mental health, with people experiencing more symptoms of anxiety and depression and worse overall well-being if they reported sleeping for longer or shorter stints. (Hunt, 5/2)

CNN: Vegetarian And Meat-Eating Children Have Similar Growth And Nutrition But Not Weight, Study Finds 
If you're wondering how your child might fare on a vegetarian diet, a new study offers some factors to consider. Children eating a vegetarian diet and children who ate meat were similar in terms of growth, height and nutritional measures, but vegetarian children had higher odds of being underweight, according to a study published Monday in the journal Pediatrics. "Over the last 20 years we have seen growing popularity of plant-based diets and a changing food environment with more access to plant-based alternatives, however we have not seen the research into the nutritional outcomes of children following vegetarian diets in Canada," said Dr. Jonathon Maguire, the study's lead author and a pediatrician at St. Michael's Hospital of Unity Health Toronto, in a news release. (Rogers, 5/2)

On health tech —

Stat: Meet The Policy Makers Who Want To Bring Health Tech Into The Home 
Years into the pandemic’s almost overnight transition to virtual care, providers and health plans are now scrambling to build sustainable systems that can more permanently treat patients in their homes via telehealth or other means, a trend they say could cut costs and make health care more convenient for patients. There’s widespread interest. Health systems are piloting their own “hospital at home” programs, some of which use biometric sensors to passively monitor patients before their conditions worsen, minimizing unnecessary in-person visits. Industry giants like UnitedHealth Group are poised to spend billions of dollars on home health providers; Amazon’s clinic chain Amazon Care threw its weight behind home health when it joined the Moving Health Home policy coalition last year. (Ravindranath, 5/2)