FDA to Expand Review of Chemical Preservatives Used in Food
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The Food and Drug Administration is planning to expand its review of food additives beyond artificial dyes, targeting preservatives and chemicals used as whitening agents and dough conditioners.
The agency will issue an updated list of chemicals that it will evaluate, including the common preservatives butylated hydroxytoluene, or BHT, and butylated hydroxyanisol, or BHA. Azodicarbonamide, or ADA, a whitening agent used in cereal flour and as a dough conditioner, will also be on the list, the agency said in a statement.
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28bio Announces Nexon™ Neurotechnology Platform Powered by Engineered Human Brains
Exhibits complex neurological processes—including memory, learning, and cognition—and predicts human outcomes in preclinical drug development NEW ORLEANS, June 9, 2025 /PRNewswire/ -- 28bio today announced the Nexon™ neurotechnology platform—a major advancement in understanding human brain function. The platform integrates tissue engineering, neural interfacing and AI to engineer human brains at-scale and replicate complex neurological processes. The Nexon™ platform is now being used to improve the prediction of therapeutic efficacy and toxicity in humans, with several of the world's largest pharma companies already integrating Nexon™ into their drug development workflows. The Nexon™ platform also incorporates Organoid Intelligence (OI). The growing field of OI combines human brain organoids with brain-machine interfaces to model memory, learning, and cognition in vitro, offering novel functional cognitive biomarkers with the potential to reshape drug development in neurodegenerative disorders including Alzheimer's disease. Neurological drug development faces some of the highest failure rates in the pharmaceutical industry, due to poor translatability of animal models. Despite promising preclinical study results, many therapies ultimately fail in humans—contributing to a growing neurological health crisis and need for more predictive, human-relevant models. "We engineer human brains capable of elucidating the complexity of neurological processes and produce predictive data needed to change the trajectory of neurological drug development," said Alif Saleh, CEO of 28bio. "Industry and regulators are urgently asking for solutions to develop better neurological drugs faster and cheaper." About 28bio28bio is a neurotechnology company engineering human brains at-scale exhibiting memory, learning, and cognitive functions. Its Nexon™ platform integrates tissue engineering, neural interfacing, and AI to reverse today's neurological health crisis by improving the ability to predict which therapies will work in humans. 28bio is committed to advancing ethical standards in the development of brain organoid technology and engineered human cognition. For more information, visit View original content to download multimedia: SOURCE 28bio Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Dating apps might be messing with your mental health
Jenny O'Hara initially signed on to a dating app to bump up her confidence. Fresh out of a 20-year marriage, the Neptune Township, New Jersey, resident didn't believe a man would ever find her attractive again. A friend suggested she try dating online, so she created a profile on Facebook. 'I was looking for people to tell me: 'You're okay. Even though you just got divorced, you're still marketable,'' she said, adding that she did get attention from men online. 'And that made me feel better - not for a long time, but it made me feel better for a little bit of time.' Subscribe to The Post Most newsletter for the most important and interesting stories from The Washington Post. But when some men asked her for racy photos, she retreated. 'You would never say something like that to somebody if you were sitting at a bar with them,' she said. O'Hara is among the some 95.6 million people 18 and over who have used dating websites or apps, according to the research firm SSRS. And she's not alone in seeing her mood shift downward the longer she was online. 'My experience with patients who are on dating apps is it leads to fatigue, that people just get exhausted,' said Paul Hokemeyer, a licensed marriage and family therapist based in Telluride, Colorado. 'It takes up a lot of energy. It takes up a lot of time. It takes up a lot of emotions. And there's a huge potential for rejection.' - - - Addictive behavior In 2022, 3 in 10 U.S. adults said they had used a dating site or app, with some 9 percent reporting having used one in the past year, according to surveys conducted by the Pew Research Center. According to SSRS, Tinder is the nation's most popular dating app. (Pew reports that some 14 percent of all U.S. adults say they've used it.) While Tinder was also the most popular among those 18 to 49, Match was the preferred app among those ages 50 and older, SSRS found. But popularity doesn't equate with only positive experiences, and some experts say online dating can generate mental health hazards. For one, users can become addicted to apps and to the dopamine rush they get when someone they're interested in responds to them, Hokemeyer said. Objectification also happens, as people are focused more on veneer than substance, he added. 'They're reduced to transactions, and for patients who suffer from mental health disorders, which is basically everyone I see, the deeper their level of depression, the deeper their level of anxiety, the deeper their level of engagement with these apps seem to be,' he said. There's also a kind of doomscrolling that goes on with dating apps, not unlike the way people scroll news headlines on their phone, wading through bad news. 'People are constantly looking for validation and a dopamine and serotonin rush that doesn't happen, and if it does happen, it's fleeting and makes them want to go back for more,' he said. 'It doesn't enhance their well-being, like being present in their lives, looking for elevation from within, connecting to human beings in real time.' - - - Pros and cons Online dating can make people feel unattractive or unworthy, particularly when apps involve swiping or expressing mutual attraction to contact someone, said Racine Henry, a licensed marriage and family therapist who sees clients virtually in New York, New Jersey and North Carolina. The apps can be particularly negative for young people, who do not yet have the emotional development to put such rejection in context, she said. 'Apps like that can really make people feel ugly and unwanted,' Henry said. 'I do feel that self-esteem, self-confidence, even self-identity, need to be at healthy levels prior to engaging on those apps and that people should not put too much stock into what a person who's assessing you from a few pictures and a few lines on a screen may think or feel about you.' That said, there are upsides to these apps. They can benefit people who are introverted, have certain phobias, or perhaps have experienced dating or sexual traumas that have made them reluctant to meet people in real-life settings, such as bars, she said. 'Apps are a good way for them to meet people in a safe environment and take their time with getting to know them and be able to control more of this person's access to them,' Henry said. The key is finding someone with common goals. If two people start talking and one is looking for love while the other simply wants a sexual interaction, not only might that result in a negative experience for both of them, but it could also affect one party's safety. Each person should clearly articulate what they're looking for, she said. It's all about expectations, said Nicole Karwashan, a licensed marriage and family therapist in White Plains, New York, who met her now-fiancé online. 'When somebody goes on to a dating app with this expectation of seeking external validation or finding the love of their life, I absolutely think it could perpetuate symptoms of depression,' she said. Karwashan said she hasn't seen dating apps cause depression, but she has seen dating app usage set off her clients' eating disorders, as they try to curate their profiles so they look or present in a certain way. 'It's definitely gotten pretty bad with some of my clients,' she said. 'That's when we say: 'Okay, what's the intention? Why are we giving this app and these random people this much power?'' The problem, as with all social media, is the compulsive nature of them, she said. Karwashan has clients whose app usage is so chronic that notifications on their phones will go off during their sessions, and they'll say, 'That's one of my Tinder matches,' or, 'That's some guy I met on Bumble.' 'I actually encourage breaks from social media, just to avoid that kind of addictive tendency that it can bring,' she said. Hokemeyer said he works with his patients to get them off dating apps because he wants them to better tolerate short-term discomfort in a relationship to obtain long-term gain, and to learn resiliency - and dating apps, because of their transactional nature, don't allow for that in the way real-time relationships do. - - - 'Burned Haystack' After O'Hara lost faith in her initial experience, she changed her profile and began following something called the 'Burned Haystack' dating method, which was conceived by Jennie Young, a writer and associate dean at the University of Wisconsin at Green Bay. The haystack theory is that people are more likely to find partners if they specify what they want in their profiles and refrain from dating - and perhaps go so far as to block - anyone who doesn't fit the criteria. Young launched a Facebook group, the Burned Haystack Dating Method, and it has more than 198,000 members. O'Hara said she wanted someone who was a Democrat, had a job, liked cultural events in New York City and didn't live with their ex-wife, an issue that arose a surprising number of times. Her wish list was so specific, no one responded for days at a time. But that's part of the process, she said. Finding the right person takes time. In her case, it took about a month. O'Hara and her boyfriend have now been dating for a year and a half. 'I was asking for what I want instead of just being like, 'I'll be happy with what comes my way,'' she said. Even O'Hara, who's happily in a relationship, said she occasionally misses the 'Missing you' texts she would get from men she met online. But she said she realizes now that wasn't healthy for her or for them. That is, the men online were not just on there to make her feel better about herself, nor was she on there to satisfy their needs. 'I think that's one of the interesting things about these dating apps,' she said. 'People go on them just looking at these pictures and profiles, not realizing that there are real people on the other side.' - - - 5 things to keep in mind - Limit time on dating apps - only check apps or sites once a day. - Decide what's important to you in a partner and ask for it. - Seek someone with common goals (e.g., make sure you're both looking for the same thing, like a relationship leading to marriage, not just sex). - Don't seek validation through a dating app. - If you're prone to depression, be aware of how online dating is affecting your mental state. Related Content To save rhinos, conservationists are removing their horns Donald Trump and the art of the Oval Office confrontation Some advice from LGBTQ elders as WorldPride kicks off amid fears
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Everest Medicines Presents Positive Results in Preliminary Analysis of Phase 1b/2a Clinical Trial of Novel BTK Inhibitor EVER001 at the 62nd Congress of the European Renal Association
EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of primary membranous nephropathy (pMN) and other autoimmune renal diseases, including IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN), offering treatment options for over 10 million patients worldwide. No drug has been approved globally for the treatment of pMN currently. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan. As of December 17th, 2024, the ongoing Phase 1b/2a clinical trial of EVER001 includes longer-term data collected from some patients: 10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment. Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases.- Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24.- In the low-dose cohort, a 78.0% of reduction in proteinuria was observed by the end of 36 weeks of treatment. This reduction was sustained through week 52. In the high-dose cohort, a 70.1% of reduction in proteinuria at week 24 was shown.- EVER001 was generally safe and well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors were observed. SHANGHAI, June 9, 2025 /PRNewswire/ -- Everest Medicines (HKEX "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor will be presented in a focused oral session at the 62nd Congress of the European Renal Association (ERA 2025). Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases. This initial unveiling of the preliminary data at an international congress focuses on pMN, which is the second most common cause of primary glomerulonephritis. EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. This oral presentation highlights an ongoing Phase 1b/2a clinical trial of EVER001 for the treatment of pMN, which is being conducted in China. The study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. A total of 31 patients with biopsy-proven pMN who tested positive for anti-PLA2R autoantibodies were enrolled into two cohorts. The total treatment duration was 36 weeks. The presentation includes longer-term data collected from some patients (10 patients in the low-dose cohort completed 52 weeks of follow-up, and 10 patients in the high-dose cohort completed 24 weeks of treatment). Preliminary results showed that EVER001 was well-tolerated and effective in patients with pMN. These results support the potential of EVER001 as a treatment for proteinuric autoimmune glomerular diseases. The trial results, based on data analysis as of December 17th, 2024, demonstrated that EVER001 was generally safe and well tolerated, with the most common TRAEs being Grade 1-2. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors, such as bleeding, arrhythmia, severe infections, or severe liver function impairment were observed. Compared to baseline, the least squares (LS) geometric mean levels of anti-PLA2R autoantibodies decreased by 62.1% in the low-dose cohort and 87.3% in the high-dose cohort at week 12. The reductions in both cohorts reached approximately 93% at week 24. 76.9% of patients in the low-dose cohort and 81.8% in the high-dose cohort achieved immunological complete remission at week 24. For 24-hour proteinuria, the LS geometric mean decreased by 78.0% from baseline in the low-dose cohort at week 36 and the reduction was maintained for 16 weeks after the end of treatment. At week 36, 69.2% of patients in the low-dose group achieved clinical remission. In the high-dose cohort, proteinuria had already decreased by 70.1% at week 24, with 80.0% of patients achieving clinical remission. Patients in both cohorts maintained stable renal function during the treatment period. "As a next-generation BTK inhibitor, EVER001 offers key advantages, including covalent reversibility, high selectivity, strong target-binding affinity, and reduced off-target toxicity. These attributes highlight its substantial potential in the treatment of pMN." Professor Minghui Zhao, leading principal investigator of EVER001 and an influential nephrologist at Peking University First Hospital, said: "Preliminary results from the Phase 1b/2a clinical trial of EVER001, presented at the 62nd ERA Congress, demonstrate that EVER001 induced rapid reductions in anti-PLA2R autoantibodies and proteinuria observed across both low- dose and high-dose cohorts. The treatment exhibits a favorable safety and tolerability profile. Currently, no drug has been approved globally for the treatment of pMN. Traditional immunosuppressive therapies carry a high risk of relapse following discontinuation, and many are associated with adverse effects. We therefore hope that new treatment options will become available to offer patients safer and more effective therapies." "To date, no drug has been approved globally for the treatment of pMN. As a potential best-in-class therapy, EVER001 holds promise to offer more treatment options for over 10 million patients worldwide affected by pMN, IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN)." Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said: "We are very pleased to see that the positive results in the preliminary analysis of our Phase 1b/2a clinical proof-of-concept trial of EVER001 were presented for the first time at an international academic conference. These preliminary results, disclosed at the 62nd ERA Congress, demonstrated that this next-generation covalent reversible BTK inhibitor was well-tolerated and effective in patients with pMN. Moving forward, we will continue to drive the global clinical development of EVER001, to meet patients' urgent clinical needs." pMN is a common pathological type of nephrotic syndrome in adults, and its prevalence in China has been increasing, ranking second only to IgA nephropathy[1]. There are approximately 2 million patients with pMN in China, and nearly 220,000 patients in the United States, Europe and Japan. There are no approved drugs for this indication worldwide. The current treatment goal is to improve remission rates, reduce high relapse rates, and minimize the risk of chronic toxicity caused by currently available treatments. More than one-third of pMN patients still progress to end-stage renal disease under current standards of care. This Phase 1b/2a clinical trial was approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022 to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. About EVER001 EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References: 1. Expert consensus on the application of rituximab in the treatment of membranous nephropathy, Chin J Intern Med, March 2022, Vol. 61, No. 3. View original content: SOURCE Everest Medicines Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
