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US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You'll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take
Varal Celeste está no ar!E aí cruzeirense, tudo bem com vc?No episódio de hoje tivemos:Palmeiras x CruzeiroEscalação.Análise do jogo.Resultado não foi ruim, mas poderia ter sido melhor.Fabrício Bruno, Wanderson e Villalba pagam o preço da péssima arbitragem.Arbitragem protagonista. A CBF conseguiu.Situação de tabela.Portais de notícias: Globo Esporte — Cruzeiro Deus me Dibre — Cruzeiro No Ataque — Cruzeiro Itatiaia — Cruzeiro O Tempo — Cruzeiro SamucaTV Central da Toca FB TVE aí, curtiu o episódio?Compartilhe com a galera!Se cuidem pessoal!Abraços!Redes sociais: Twitter pessoal: @VaralCeleste Instagram da coleção/podcast: @varalceleste
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength. You'll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them
[Patrocinado] Saiba mais como a IA generativa pode ajudar os softwares de gestão a transformar toda uma empresa. https://hubs.ly/Q03K8CKd0Confira a programação do Bloomberg Línea Summit 2025Siga o nosso Instagram!
No episódio 88 de De Repente Cringe, Luisa e Nanna falam sobre a volta do cringe. Como as coisas são voláteis, o vai e vem das tendências e a volta da cultura pop dos anos 2000.Luisa e Nanna vestem Insider #insiderstoreAproveitem a Black Insider: com o nosso cupom CRINGE os descontos podem chegar em até 50% OFF por tempo limitado.https://creators.insiderstore.com.br/CRINGEKITAgradecimento especial ao nosso produtor de vídeo João (@goncalves.joao_) e à Caru Coelho (@carucoelho) que cuida da nossa beauty.Encomende aqui a sua caneca do Pod na Enlevo: https://www.enlevoatelie.com/produtos/xicara-de-repente-cringe/ Instagram: @derepentecringepod*Escute também nas plataformas Youtube e Apple Podcast.
Influenciadoras se filmando e pegando pódio, pode? Não, pode! Caos na entrega de medalhas da corrida da Rede Pharma em Campina Grande (PB), corrida fala que foi desautorizada pela prefeitura que disse que nunca autorizou nada, e uma nova maratona em Braslia, mas agora com pedigree.Assine a nossa newsletter e fique sempre bem informado - https://substack.com/@corridanoarO Corrida no Ar News é produzido diariamente e postado por volta das 6 da manhã.
Manchester United vence o clássico contra o Liverpool: será que agora vai? 00:00 - Abertura 01:00 - A ausência e a mensagem do João 04:00 - Os destaques da rodada 05:00 - Man United: estamos iludidos? 06:50 - Escalação e melhores do Man United 09:00 - Já pediram desculpa pro Maguire? 10:00 - Os tabus quebrados pelo United 11:30 - Os problemas do Liverpool 19:55 - Como seria o mundo com o Klopp no United? 21:25 - Entrevista Matheus Cunha 24:50 - Casemiro neles 26:30 - A demissão de Ange Postecoglou 33:40 - Mais uma vitória do Chelsea! 39:00 - A liga dos treinadores 41:00 - Palace x Bournemouth, o jogo da rodada 48:00 - Guuuuuuuners! 56:40 - Entrevista Declan Rice 58:50 - City e Haaland 01:03:50 - Haaland, Kane ou Mbappe? 01:06:10 - Tottenham… 01:11:10 - Outros jogos da rodada Learn more about your ad choices. Visit podcastchoices.com/adchoices
@igrejakyrios | Igreja Evangélica KyriosCulto do dia 19.10.2025 no período da Manhã - 09HJoel 2:28-32 | Atos 2:14-21Na palavra, o Pr. Klaus nos conduz por uma jornada entre Joel 2:28-32 e Atos 2:14-21, mostrando que a promessa do derramar do Espírito Santo não ficou no passado — ela continua viva e acessível hoje.Com exemplos marcantes dos grandes avivamentos da história, como o movimento de Jonathan Edwards, George Whitefield e John Wesley, o pastor nos lembra que o Espírito ainda se move, despertando corações que desejam viver uma fé cheia de presença, arrependimento e paixão por Deus.Compreenda que o verdadeiro avivamento é voltar a sentir de novo, o desejo profundo pela presença de Deus; que o fogo do Espírito transforma, enquanto a frieza apaga; e que nem todos entenderão o despertar, mas quem o vive nunca mais é o mesmo.Deixe o Espírito reacender o que se apagou.Volte a sentir. Volte à Presença. Compartilhe essa palavra com alguém que precisa de uma palavra... Ouça nossas músicas autorais!Meu Lugar - https://youtu.be/htZ9wZZryaMMinha Adoração - https://youtu.be/6kQtwF0m67kSe conecte conosco!https://portal.igrejakyrios.com.br/fale-conosco/Inscreva-se no nosso canal: www.youtube.com/@igrejakyrios Nosso Site: http://www.igrejakyrios.com.brInstagram: https://www.instagram.com/igrejakyrios/
Já parou para se perguntar o porquê de determinados desafios se repetirem na sua vida? Então respira fundo porque u vou te revelar a chave para sair deles
Tom Fletcher participou de encontro de líderes sobre plano de paz proposto pelos Estados Unidos; ele pediu que todos os corpos de reféns falecidos sejam devolvidos pelo Hamas e que forças israelenses removam obstáculos à entrega de assistência.
O Bate-Pronto de hoje falará tudo sobre os jogos de ontem pelo Brasileirão. O Palmeiras deu show de novo: goleou o Bragantino por 5 a 1 e segue na liderança. O segundo colocado Flamengo, por sua vez, também conseguiu um excelente resultado: enfiou 3 a 0 no Botafogo em pleno Estádio Nilton Santos.
Em cada dia, Luís Caetano propõe um poema na voz de quem o escreveu.
Nesse extenso episódio, a mesa completa navega por um oceano de dicas pré-planejadas ou não; Miriam já viu o aclamado One Battle After Another, com os lendários Leo Dicaprio e Paul Thomas Anderson, mais um elenco estelar; Cosma relembra que é essencial assistirmos Smiling Friends, a melhor animação atualmente. Também falamos de mais um fraco Tron, do Monster falando do OG serial killer, que inspirou vários filmes, e muito mais. Vem ouvir!
Siga nosso canal de CORTES: https://www.youtube.com/@IconografiadaHistoria-cortesAJUDE-NOS A MANTER O CANAL ICONOGRAFIA DA HISTÓRIA: Considere apoiar nosso trabalho, participar de sorteios e garantir acesso ao nosso grupo de Whatsapp exclusivo: https://bit.ly/apoiaoidhSe preferir, faz um PIX: https://bit.ly/PIXidhSiga ICONOGRAFIA DA HISTÓRIA em todas as redes: https://linktr.ee/iconografiadahistoriaoficialSiga o JOEL PAVIOTTI: https://bit.ly/joelpaviottiApresentação: Joel PaviottiTexto e roteirização: Adriana de PaulaRevisão: Adriana de PaulaCâmera e produção: Fernando ZenerattoEdição: Eduardo GoesDireção: Fernando Zeneratto / Joel Paviotti
Edgard Maciel de Sá, Cauê Rademaker, Phill e Giba Perez analisam a atuação contra o Mirassol, a anulação do gol de Acosta, o momento do argentino e a importância da Data Fifa para o trabalho de Zubeldia. DÁ O PLAY!
Ficção científica, sessão dupla, o impacto cultural de Glee, sessões de meia-noite (ou cultos religiosos), a transgressão da heteronormatividade, travestis da transsexual Transilvânia e complôs alienígenas.Os Esqueletos fazem o Time Warp agora, nesta regravação especial do nosso episódio sobre The Rocky Horror Picture Show.Disponível com exclusividade para TODOS os nossos Apoiadores:https://apoia.se/esqueletosgayshttps://orelo.cc/esqueletosgaysApresentado por:Luiz Machado - @machadolueJoão Neto - @jonetoooAlvaro de Souza - @alllvarusdesouzaCom a participação especial de Arthur Eloi - @arthureloi117Confira o nosso site: esqueletosnoarmario.com/@esqueletosgays no Twitter e InstagramAcesse o apoia.se/esqueletosgaysNossos perfis no Letterboxd são:https://letterboxd.com/zcomluiz/https://letterboxd.com/alvarosouza/https://letterboxd.com/netodojo/
Jornalismo e reflexões sobre a Fórmula 1. Para apoiar o nosso projeto, basta se tornar membro do canal e curtir as premiações: https://www.youtube.com/channel/UCXeOto3gOwQiUuFPZOQiXLA/join Conheça também a Noovamais: mais do que uma corretora, uma revolução no mercado de seguros e financiamentos! Acesse www.noovamais.com.br e confira também no Insta @NoovaMais Se preferir um formato diferente de Apoio ao nosso canal, confira as facilidades do http://www.apoia.se/cafecomvelocidade para ajudar o Café a crescer e se manter no ar. E se você curte a agilidade e rapidez do PIX, você pode se tornar apoiador através da chave cafecomvelocidade@gmail.com (este também é o nosso endereço para contato) APOIANDO O CAFÉ VOCÊ RECEBE: Faixa Café com Leite - Acesso a um grupo exclusivo de membros do canal no whatsapp Faixa Capuccino - O mesmo benefício + acesso a LIVES Exclusivas toda terça-feira pós GP de Fórmula 1 Faixa Extra Forte - Os mesmos benefícios + concorre em sorteios de assinaturas da F1TV até o FINAL DE 2026 ! Faixa Premium - Os mesmos benefícios + concorre também a miniaturas de F1, acesso ao grupo Premium, pode PARTICIPAR das LIVES Exclusivas e concorre a ingressos para o GP do Brasil de F1 de 2025 em Interlagos Não deixe de nos seguir no X / Twitter (@cafevelocidade) e no Instagram (@cafe_com_velocidade) Siga nossa equipe no X / Twitter: @ricardobunnyman, @brunoaleixo80 e @camposfb #formula1 #f1 #f12025 #singaporegp #singaporegrandprix #singapore #azerbaijangp #bakugp #gpazerbaijão #italiangp #italiangrandprix #gpitalia #monzacircuit #dutchgp #dutchgrandprix #zandvoort #zandvoortgp #gpholanda #hungariangp #hungaroring #gphungria #belgiumgp #spafrancorchamps #gpbelgica #britishgp #britishgrandprix #british #silverstone #inglaterra #austriangp #austria #gpaustria #canadiangp #canadiangrandprix #canada #gpcanada #spanishgp #spain #gpdaespanha #monacogp #monaco #gpmonaco #emiliaromagnagp #imolagp #imola #gpimola #miamigp #miami #gpmiami #saudiarabiangp #saudiarabia #gparabiasaudita #bahraingp #bahraingrandprix #bahrain #gpbahrain #gpbahrein #japanesegp #japangp #japão #gpjapão #chinesegp #gpchina #australiangp #australiangrandprix #ausgp #australia #gpaustralia #f1testing #noticiasdaf1 #formulaone #f1today #f1tv #f1team #f1teams #f1agora #f1brasil #preseason2025 #ferrari #mercedes #redbull #redbullracing #lewishamilton #maxverstappen #charlesleclerc #carlossainz #fernandoalonso #mclaren #landonorris #oscarpiastri #georgerussell #podcast #podcasts #podcasting #automobilismo #raceweekend #raceweek #f12024 #formula12024 #f1news #f12026 #alpine #alpinef1 #f1motorsport #f1moments #f1movie 0:00 Abertura: Café traz os destaques da F1 em Singapura 11:47 Participe da promoção e concorra a miniatura de F1 16:31 Singapura e os sintomas de uma F1 problemática ! 27:56 O que Singapura revela sobre a disputa pelo título ? 46:17 O que explica a inesperada vitória de George Russell 59:46 Em qual "prateleira" Russell se encaixa na F1 atual ? 1:17:48 Red Bull: a surpreendente performance em Singapura 1:33:46 Sem Verstappen a disputa teria a mesma emoção ? 1:37:54 Quais são de fato as "rivalidades" na Fórmula 1 atual 1:44:08 McLaren: equipe virou vítima das próprias regras 2:00:12 Norris e Piastri: como pilotos são parte do problema 2:09:32 Como fica disputa interna na McLaren pós-Singapura 2:32:38 As questões que ficam sobre McLaren e seus pilotos 2:43:31 Questões sobre a Fórmula 1 após o GP de Singapura
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sanofi lowers prices, oral pill for T1D prevention studied, updates from Medtronic, Tandem, and Sequel Med Tech, falsely lower A1Cs (and why that happens), Biolinq gets FDA okay for micro-needle CGM and more! Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX French drugmaker Sanofi says it would offer a month's supply of any of its insulin products for $35 to all patients in the U.S. with a valid prescription, regardless of insurance status. The program, originally meant for uninsured diabetes patients, would now include those with commercial insurance or Medicare, the drugmaker said. Patients will be able to purchase any combination, type, and quantity of Sanofi insulins with a valid prescription for the fixed monthly price of $35, starting January 1. Lilly and Novo also have similar programs through which they offer insulin products for $35 a month for U.S. patients regardless of whether the patients have insurance. There is no law at work here – the only legislation that has changed the price of insulin came with the Inflation Reduction Act in 2022 with the Medicare cap. Helping lower the cost here, biosimilars hitting the market and the huge profitability for GLP-1 drugs for Novo and Lilly https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-offer-all-insulin-products-35-per-month-us-2025-09-26/ XX A pill typically prescribed for rheumatoid arthritis and alopecia might help slow the progression of type 1 diabetes, a new study says. Baricitinib (bare-uh-SIT-nib) safely preserved the body's own insulin production in people newly diagnosed with type 1 diabetes.. and their diabetes started progressing once they stopped taking baricitinib, results show. They produced less insulin and had less stable blood sugar levels. Baricitinib works by quelling signals in the body that spur on the immune system, and is already approved for treating autoimmune conditions such as rheumatoid arthritis, ulcerative colitis and alopecia, researchers said. “Among the promising agents shown to preserve beta cell function in type 1 diabetes, baricitinib stands out because it can be taken orally, is well tolerated, including by young children, and is clearly efficacious,” Waibel said. “We are hopeful that larger phase III trials with baricitinib are going to commence soon, in people with recently diagnosed type 1 diabetes as well as in earlier stages to delay insulin dependence,” she added. “If these trials are successful, the drug could be approved for type 1 diabetes treatment within five years.” Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. https://www.usnews.com/news/health-news/articles/2025-09-23/pill-effective-in-slowing-type-1-diabetes-progression XX An existing transplant drug has shown promise in slowing the progression of type 1 diabetes in newly diagnosed young people, potentially paving the way for the first therapy that modifies the disease after diagnosis. The Drug, called ATG, is currently used together with other medicines to prevent and treat the body from rejecting a kidney transplant. It can also be used to treat rejection following transplantation of other organs, such as hearts, gastrointestinal organs, or lungs. The researchers studied 117 people aged five to 25, who'd been diagnosed with type 1 diabetes within the past three to nine weeks. The participants were from 14 centers across eight European countries and were randomized to be given different doses of ATG (0.1, 0.5, 1.5, or 2.5 mg/kg) or a placebo. ATG was given as a two-day intravenous (IV) infusion. The main goal was to see how well the pancreas could still make insulin after 12 months, measured by C-peptide levels during a special meal test. C-peptide is released into the blood along with insulin by the pancreas. The findings are promising, showing that ATG, even at a relatively low dose, can slow the loss of insulin-producing cells in young people newly diagnosed with type 1 diabetes. The lower dose also caused fewer side effects, making it a more practical option. https://newatlas.com/disease/antithymocyte-globulin-newly-diagnosed-type-1-diabetes/ XX The FDA has delayed its feedback on Lexicon Pharmaceuticals' application to bring Zynquista (sotagliflozin) to people with type 1 diabetes. The agency had planned to respond this month but will now wait until the fourth quarter after reviewing new data from ongoing studies. Zynquista, an oral drug meant to be used with insulin, has already been approved for heart failure (marketed as Inpefa). But in type 1 diabetes, it faces safety concerns: last year an FDA advisory committee voted 11–3 that its benefits don't outweigh the increased risk of diabetic ketoacidosis (DKA). The FDA later issued a complete response letter rejecting the drug. Lexicon is still pushing forward, hoping its additional submissions will strengthen Zynquista's case for type 1 diabetes approval. https://www.biospace.com/fda/after-fda-rejection-lexicons-type-1-diabetes-drug-hit-with-another-regulatory-delay XX A common but often undiagnosed genetic condition may be causing delays in type 2 diabetes diagnoses and increasing the risk of serious complications for thousands of Black and South Asian men in the UK—and potentially millions worldwide. A new study found around one in seven Black and one in 63 South Asian men in the UK carry a genetic variant known as G6PD deficiency. Men with G6PD deficiency are, on average, diagnosed with type 2 diabetes four years later than those without the gene variant. But despite this, fewer than one in 50 have been diagnosed with the condition. G6PD deficiency does not cause diabetes, but it makes the widely used HbA1c blood test—which diagnoses and monitors diabetes—appear artificially low. This can mislead doctors and patients, resulting in delayed diabetes diagnosis and treatment. The study found men with G6PD deficiency are at a 37% higher risk of developing diabetes-related microvascular complications, such as eye, kidney, and nerve damage, compared to other men with diabetes. "This study highlights important evidence that must be used to tackle these health inequalities and improve outcomes for Black communities. Preventative measures are now needed to ensure that Black people, especially men, are not underdiagnosed or diagnosed too late." https://medicalxpress.com/news/2025-09-hidden-genetic-delay-diabetes-diagnosis.html XX Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes. The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. XX Interesting news from Sequel Med Tech – they've signed an agreement with Arecor to pair the twiist pump with AT278 an ultra-concentrated (500U/mL), ultra-rapid insulin in development. They also have a deal with Medtronic to develop insulin for new pumps. This insulin isn't yet approved, it's 5 times stronger than standard fast acting it's hoped that a clinical study will begin next year. Arecor says its insulin could potentially be the only option capable of enabling and catalyzing the next generation of longer-wear and miniaturized automated insulin delivery systems. https://www.drugdeliverybusiness.com/sequel-arecor-develop-rapid-insulin-twiist/ XX Tandem Diabetes Care announes its t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company's Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the United States (U.S.). – The t:slim X2 insulin pump with Control-IQ+ technology is now cleared for use with Lyumjev for people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes. The companies are continuing to work toward securing Lyumjev compatibility for the Tandem Mobi pump. https://hitconsultant.net/2025/09/29/tandem-diabetes-cares-tslim-x2-pump-cleared-for-use-with-lillys-ultra-rapid-lyumjev-insulin/ XX You can now place your order for the MiniMed™ 780G system with the Instinct sensor, made by Abbott. And if you are already a MiniMed 780G user, you can place an upgrade order today. This is a 15 day wear sensor, with no transmitter or overtape required. It looks the same at other Abbot sensors such as the Libre but is proprietary to Medtronic. Shipments are scheduled to start in November. https://www.drugdeliverybusiness.com/medtronic-launches-minimed-780g-instinct-abbott/ XX The global type 1 diabetes (T1D) burden continues to increase rapidly driven by rising cases, ageing populations, improved diagnosis and falling death rates. , The study estimates that T1D will affect 9.5 million people globally in 2025 (up by 13% since 2021), and this number is predicted to rise to 14.7 million in 2040. However, due to lack of diagnosis and challenges in collecting sufficient data, the actual number of individuals living with T1D is likely much higher, researchers say. In fact, they estimate that there are an additional 4.1 million 'missing people' who would have been alive in 2025 if they hadn't died prematurely from poor T1D care, including an estimated 669,000 who were not diagnosed. This is particularly true in India, where an estimated 159,000 people thought to have died from missed diagnoses. The study predicts that 513,000 new cases of T1D will be diagnosed worldwide in 2025, of which 43% (222,000) will be people younger than 20 years old. Finland is projected to have the highest incidence of T1D in children aged 0-14 years in 2025 at around 64 cases per 100,000. The substantial increases in T1D forecasts between 2025 and 2040 underscore the urgent need for action. As co-author Renza Scibilia from Breakthrough T1D explains, "Early diagnosis, access to insulin and diabetes supplies, and proper healthcare can bring enormous benefits, with the potential to save millions of lives in the coming decades by ensuring universal access to insulin and improving the rate of diagnosis in all countries." The authors note some important limitations to their estimates, including that while the analysis uses the best available data, predictions are constrained by the lack of accurate data in most countries-highlighting the urgent need for increased surveillance and research. They also note that data on misdiagnosis and adult populations remain limited, and the analysis assumes constant age-specific incidence and mortality over time. Furthermore, incidence data from the COVID-19 period were excluded from part of the modelling to avoid bias. Future updates are expected to improve as new data become available and applied. https://www.news-medical.net/news/20250919/New-study-warns-of-millions-of-undiagnosed-and-missing-people-with-type-1-diabetes.aspx XX A new study has found that semaglutide — the active ingredient found in some GLP-1 medications prescribed for diabetes and to aid weight loss — may help protect the eyes from diabetic retinopathy. Researchers estimate that as much as 40% of all people with diabetes also have diabetic retinopathy — a potentially blinding eye condition caused by blood vessel damage in the eye's retina. There is currently no cure for diabetic retinopathy. The condition is often managed through injections of anti-VEGF medications into the eye, surgery, and blood sugar monitoring and control. For this lab-based study, researchers used samples of human retinal endothelial cells that were treated with different concentrations of semaglutide. The cells were then placed in a solution with both a high glucose level and high level of oxidative stress — where there is an imbalance of antioxidants and free radicals — for 24 hours. Past studies show that oxidative stress plays a role in the formation of diabetic retinopathy. At the study's conclusion, researchers found that the retinal cells treated with semaglutide were twice as likely to survive than cells that were untreated. Additionally, the treated cells were found to have larger stores of energy. Scientists also found that three markers of diabetic retinopathy were decreased in the semaglutide-treated retinal cells. First, the levels of apoptosis — a form of cell death — decreased from about 50% in untreated cells to about 10% in semaglutide-treated cells. The production of the free radical mitochondrial superoxide decreased from about 90% to about 10% in the treated retinal cells. Researchers also found the amount of advanced glycation end-products — harmful compounds that can collect in people with diabetes and are known to cause oxidative stress — also decreased substantially. Lastly, scientists reported that the genes involved in the production of antioxidants were more active in the semaglutide-treated cells when compared to untreated cells. Researchers believe this is a sign that semaglutide may help repair damage to the retinal cells. “Our study did not find that these drugs harmed the retinal cells in any way — instead, it suggests that GLP1-receptor agonists protect against diabetic retinopathy, particularly in the early stages,” Ioanna Anastasiou, PhD, molecular biologist and postdoctoral researcher at the National and Kapodistrian University in Greece, and lead author of this study, said in a press release. “Excitingly, these drugs may be able to repair damage that has already been done and so improve sight. Clinical trials are now needed to confirm these protective effects in patients and explore whether GLP-1 receptor agonists can slow, or even halt, the progression of this vision-robbing condition.” https://www.medicalnewstoday.com/articles/ozempic-semaglutide-may-help-protect-against-diabetes-related-blindness-retinopathy XX Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. This one is tricky – it's called a needle free CGM but it also says it uses micro needles. By the way, De Novo isn't exactly the same as what we think of for FDA approval for medical devices. It's not as rigorous but it's a streamlined route for novel, low to moderate risk devices with no existing equivalent. We'll see how this one turns out. https://www.hmenews.com/article/biolinq-s-multi-function-biosensor-receives-fda-de-novo-classification
Anna Wood, Editor at Startups Magazine, speaks to Mark Sweeny, Founder and Group Chief Executive de Novo Solutions, all about always focusing on the fundamentals, championing the Welsh ecosystem and winning the Most Successful Scaleup Award at the Hustle Awards 2025.
人工智慧(AI)如何改變藥物開發?藥物開發從臨床前研究到臨床試驗,通常需要超過十年時間和數十億美元的投資,卻仍有高達九成的藥物在臨床試驗中失敗。這些挑戰,現在 AI 正在各種方面掀起革命。在這系列節目中,我們將探討 AI 在藥物開發領域中的應用,並介紹在這個快速發展的領域中工作的專家。 本集為《AI 藥物開發系列》的第三集。我們邀請到加州大學聖塔克魯茲分校的葉先偉教授。他曾在諾貝爾獎得主 David Baker 的實驗室進行博士後研究。本集主題將探討 AI 蛋白質設計,介紹他如何設計新型 luciferase 與生物感測器 biosensor,並講解 2024 年諾貝爾獎的研究,以及他對於 AI 蛋白質設計未來發展的看法。
O Falando de Nada dessa semana começa com alguns causos divertidos do final de semana, depois traz um esclarecimento sobre o retorno de Jimmy Kimmel ao ar e, na sequência, a volta da tarifa de 100% em filmes anunciada por Donald Trump, que pode trazer grandes impactos para Hollywood e para a indústria do entretenimento.Seja um membro da Guilda dos Tagarelers e participe das pautas semanais:https://www.youtube.com/channel/UCa8ekYf6l76ikQszoMYuHkw/join00:00 - Começou o Falando de Nada, contando causos do final de semana08:26 - Jimmy Kimmel já está de volta09:10 - A tarifa em filmes de 100% do Trump... DE NOVO?17:19 - Perguntinhas Marotas✉ Quer mandar sua sugestão de pauta ou dúvida? Envie um e-mail para
Faça sua assinatura! www.resumido.cc/assinatura--China ultrapassa o mundo em número de robôs, carpinteiros são contratados para serem filmados para treinamento de IA e pessoas vendem as próprias ligações também para isso. O ChatGPT quer tomar conta do seu dia, startups criam cópias de arte tão perfeitas que abrem um novo mercado. Pelo menos o Instagram promete nos dar algum controle do algoritmo.Qual o preço das nossas experiências?No RESUMIDO #332: China lidera corrida global dos robôs, carpinteiros viram espetáculo ao vivo, plataforma paga por ligações telefônicas para treinar IA, Geração Z tenta blindar carreira contra substituição tecnológica, Instagram atinge três bilhões de usuários promete controle sobre algoritmo e muito mais!--Ouça e confira todos os links comentados no episódio: https://resumido.cc/podcasts/robos-chegaram-falsas-promessas-da-ia-controle-seu-feed
Anna Wood, Editor at Startups Magazine, speaks to Mark Sweeny, Founder and Group Chief Executive de Novo Solutions, all about always focusing on the fundamentals, championing the Welsh ecosystem and winning the Most Successful Scaleup Award at the Hustle Awards 2025.
Anna Wood, Editor at Startups Magazine, speaks to Mark Sweeny, Founder and Group Chief Executive de Novo Solutions, all about always focusing on the fundamentals, championing the Welsh ecosystem and winning the Most Successful Scaleup Award at the Hustle Awards 2025.
Futebol, informação, humor, opinião e corneta! Um programa de debate sobre tudo que envolve futebol de um jeito descontraído e animado. Veja muito mais no YouTube
Muita especulação e rumores sobre Resident Evil: Village. O nono capítulo da saga vai trazer uma nova protagonista, Grace, mas o queridinho dos fãs Leon S. Kennedy também deve dar as caras, se os vazamentos forem reais. Mas o galã de Resident Evil 2 está com um novo visual e cara de pouquíssimos amigos. Correndo por fora, a Microsoft aumentou os preços de seu Xbox Series mais uma vez, com edições que pode chegar a salgados 800 dólares. O Flow Games News de hoje tá
Summary del Show: • Wall Street sube tras el primer recorte de tasas de 2025 por parte de la Fed, aunque persiste incertidumbre sobre el ciclo de flexibilización. • Nvidia $NVDA e Intel $INTC anuncian un acuerdo histórico para codesarrollar chips y $NVDA invierte $5B en acciones de Intel. • Palantir $PLTR cierra un contrato por £1.5B con el Reino Unido, convirtiendo a Londres en su hub europeo de defensa. • Novo Nordisk $NVO gana impulso tras datos clínicos que muestran ventaja cardiovascular de Ozempic frente a Trulicity de Eli Lilly $LLY.
Tema – A evidência de um coração nascido de novo. Quarta – Feira 17/09/2025 Pregador : Ap. Miguel Ângelo Neste sermão impactante, o Apóstolo Miguel Ângelo revela o coração do evangelho: o novo nascimento. Com base na conversa entre Jesus e Nicodemos, aprendemos que não são os rituais, nem as tradições, que salvam — mas sim uma obra profunda do Espírito Santo no interior do ser humano. A verdadeira evidência de um coração nascido de Deus é a regeneração, que transforma desejos, valores, afetos e dá uma nova identidade espiritual. Quem nasce de Deus não vive mais na prática do pecado, mas em comunhão com Cristo e com a igreja. Esta mensagem é um convite à reflexão, ao arrependimento genuíno e à certeza da salvação. Prepare-se para ser confrontado e edificado com a verdade que liberta e transforma. Assista até o fim e experimente o poder de uma vida verdadeiramente renovada por Deus. Aula 22 Módulo – 66 Seminário: Construindo uma casa sobre a Rocha
Edgard Maciel de Sá, Cauê Rademaker, Phill e Marcello Neves analisam a derrota para o Lanús, os erros de Renato, o planejamento dos últimos jogos e a necessidade de vencer o Vitória pelo Brasileirão. DÁ O PLAY!
O cérebro e o pensamento ideológico; o Relatório Global sobre o Estado da Democracia; reportagem no Centro Unbroken de Lviv; Gaza e França. Visão Global, edição de José Guerreiro.
Olá amigos! Mais um episódio extra garantido pela meta coletiva dos nossos amigos assinantes, mais uma vez muito obrigado!! E olha aí, se estamos fazendo mais um pré-relato de vagem, quer dizer que estamos prestes a viajar novamente aeeeeee….. E olha só, estamos mais uma vez voltando pra Flórida, pra Orlando e para mais um […]
Mais uma Queniana pega no anti doping mas agora nas montanhas, abrem hoje as inscrições para a Maratona de Floripa 2026, prefeitura de Fortaleza mexe nas regras de corrida na Beira-Mar e uma entrevista com a brasileira que trabalha na World Athletics.#corrida #corridaderua #corridaderuabrasil #criadorporesporte #worldathletics #cnanews
In this episode, I sit down with Dr. Ben Fishbein — founder of Fishbein Orthodontics, multiple-time DeNovo opener, bagel store entrepreneur, and Smile Doctors partner — to break down one of the most misunderstood topics in orthodontics today: DSOs, OSOs, and what it really means to join one.If you've ever said, “I'm not ready,” “I could never give up control,” or “I don't need help,” this episode is for you. Ben was once a staunch no—until he actually had the conversation. Now, with multiple thriving practices, ownership in a national DSO, and an expanding local business portfolio, he shares what changed his mind—and why most orthodontists are asking the wrong questions entirely.Whether you're exploring a potential sale, considering DeNovos, or just want to sharpen your vision, this episode will reframe how you think about your career path—and the opportunities right in front of you.QUOTES"The most frustrating thing to me is when someone says, ‘I'm not ready to talk yet.' Why are you not ready to learn something that might be so good it changes your life?"— Dr. Glenn Krieger"I was a naysayer too. I told the Smile Doctors team, ‘There's less than a 2% chance I do this.' Then I listened—and it all started making sense."— Dr. Ben FishbeinKey Takeaways04:50 – Why so many orthodontists dismiss DSOs without ever really hearing the facts06:50 – “30 years in 7” — how Ben's early hustle shaped his future faster08:36 – Why listening to opportunities is part of your duty to your team10:15 – Why selling a practice isn't selling out—and how orthodontists misjudge entrepreneurship15:12 – How partnering opened Ben's eyes to investments he never considered before16:48 – The surprisingly valuable business lessons from running a bagel shop20:19 – Why Smile Doctors' DeNovo model works—and how it's redefining growth24:18 – “Get the information. Don't say no to something you don't understand.”25:37 – Ben's biggest advice to younger orthodontists: “Just go for it.”Additional Resources I've seen firsthand how running the numbers—really running them—has changed the trajectory of practices and lives.Want to get in contact with Ben? https://amandafloydconsulting.com/fishbein-fundamentals This isn't about selling out or giving up control. It's about knowing your options, making smart financial moves, and understanding when an opportunity might never come back. If you've received an offer and aren't sure whether to take it, DM me. I don't get paid either way—but I've had this conversation hundreds of times and I'll help you think it through.
O Bate-Pronto de hoje atualizará e debaterá as principais informações do futebol mundial. O destaque ficará por conta da Seleção Brasileira, que terá mudanças na escalação para enfrentar a Bolívia, amanhã, na altitude. O programa também repercutirá mais um título de Rogério Ceni como treinador e muito mais!
Neste domingo, GP da Itália, 16ª de 24 etapas da F1 2025. Por isso, o Podcast Motorsport.com chega com o PÓDIO, no qual o comentarista convidado Felipe Motta, apresentador da ESPN e ex-repórter de F1 in loco, debate o GP com Carlos Costa (@ocarlos_costa) e Isa Fernandes (@isamfer_).Bitcoin e criptomoedas? Invista na Mynt, plataforma cripto do BTG Pactual - https://bit.ly/425ErVa NASCAR XFINITY E CUP SERIES: Assista com o Motorsport! - https://tinyurl.com/4f3hbjnm MITSUBISHI CUP EM MOGI - https://www.youtube.com/live/mRibAdnC_cQ?si=fKFwSpVzXcC-oWGl
Ecoutez Laissez-vous tenter - Première avec Isabelle Morini-Bosc du 01 septembre 2025.Hébergé par Audiomeans. Visitez audiomeans.fr/politique-de-confidentialite pour plus d'informations.
Neste sábado, classificação para o GP da Holanda, 15ª de 24 etapas da F1 2025, o grande retorno das férias da categoria. Por isso, o Podcast Motorsport.com chega com o Q4, em que Erick Gabriel (@erickjornalista) e Isa Fernandes (@isamfer_) recebem Fabio Tarnapolsky (@fabiotarna), ex-Motorsport, ESPN e Estadão para o debate.Bitcoin e criptomoedas? Invista na MYNT, a plataforma cripto do BTG Pactual - https://bit.ly/425ErVa NASCAR XFINITY, TRUCK E CUP SERIES: Assista com o Motorsport! - https://tinyurl.com/4f3hbjnm
In this episode of the Group Practice Accelerator podcast, Jamie sits down with Polaris in-house strategist, Founder & CEO, Diwakar Sinha to explore the growing appeal of the de novo strategy in dentistry. Instead of, or in addition to, acquiring existing practices, more dentists and DSOs are choosing to build from the ground up—and for good reason. Diwakar shares his insights into what de novos can offer within your growth strategy, and hints at an opportunity to learn firsthand what it takes to launch one successfully.
Neste episódio, falamos sobre a zebra histórica da eliminação do Manchester United na Copa da Liga Inglesa para um time de quarta divisão. Além disso, o podcast aborda a vitória sofrida do Bayern na Copa da Alemanha contra o Wiesbaden e a vitória dramática do Liverpool contra o Newcastle na Premier League. A impressionante estreia da Inter de Milão na Serie A também a pauta! E tem entrevista especial e muito mais! Vem com a gente! Learn more about your ad choices. Visit podcastchoices.com/adchoices
In this episode, we review the high-yield topic of De Novo Nucleotide Synthesis from the Biochemistry section.Follow Medbullets on social media:Facebook: www.facebook.com/medbulletsInstagram: www.instagram.com/medbulletsofficialTwitter: www.twitter.com/medbullets
DSD 6.8 | That is where you should put your money For years researchers have sought out to better understand control mechanisms for a successful transition into lactation from the dry period. We've learned changing body condition score during the dry period is not acceptable, but what if it changes during late lactation? How does this impact energy partitioning for the next lactation? Well managed high producing cows with high fertility might find themselves bred back in less than the “textbook ideal” condition score heading into the dry period. Can we alter the late lactation ration to successfully increase condition with little impact? Dr. Laura Hernandez from the University of Wisconsin worked with a team of researchers at the Forage Center to better understand what is happening if high energy is fed late in lactation through extensive data collection to determine the possible potential carry over effects for subsequent lactations. Listen into this compelling discussion as we learn more about the “black box” we know as the transition dairy cow and what phase to invest in to maximize your return. Topics of discussion 1:01 Goal of this month's research 1:40 Introduction of Dr. Laura Hernandez 2:52 Why is this topic important 5:09 Test ration design for increasing BCS in late lactation 3.25 vs 3.75 8:45 Cow responses to the ration 11:05 Figure 1a: BCS change over 12 weeks 11:45 Dry matter intake 10:27 Possible hormonal responses causing the 13:49 Energy partitioning 16:12 Genetic analysis for response and non-response 18:40 Dry cow and early ration following treatment 19:19 High energy effect on dystocia 20:50 Early lactation energy measurements 22:45 Close up - Intake differences of high and low energy 23:23 Fig 3d: Early lactation intake difference 24:44 Visceral fat changes 26:54 Denovo fatty acids in milk, 70 days post treatment 30:54 Concentration of Megalac in treatment ration 31:57 Description of animals on treatment 32:47 What do you want “boots on the ground” dairymen to learn from this project? Featured Article: Effects of high-energy and low-energy diets during late lactation on the subsequent dry period and lactation of Holstein dairy cows #2xAg2030; #journalofdairyscience; #openaccess; #MODAIRY; #transition; #latelactation; #earlylactation; #dmi; #NEFA; #BHB; #drycow; #dairysciencedigest; #ReaganBluel
Seja apoiador do X do ControleCompre seus jogos na Nuuvem! MARCAÇÕES DE TEMPO0:00:00) - Abertura(0:05:56) - Publicidade (0:06:44) - Steam perde mais um meio de pagamento por ação de ONG conservadora(0:24:42) - Pesquisa revela que Game Pass está "canibalizando" jogos triplo A(0:37:53) - Far Cry será adaptado em série de TV antológica(0:47:03) - Rapidinhas(0:56:08) - EncerramentoCRÉDITOSApresentação: Guilherme Dias e Claudio PrandoniRoteiro: Guilherme DiasEdição: Gabriel SalesThumbnail: Lucas G. FerreiraSiga o XdC: YouTube| Instagram | Bluesky | Threads | Tik TokNossas plataformas e redesContato: contato@xdocontrole.comContato para anunciantes e parcerias: comercialxdc@gmail.com
Nos reunimos no pub após mais uma conquista histórica do Crystal Palace. O clube venceu o Liverpool nos pênaltis e sagrou-se campeão da Supercopa da Inglaterra. Além do debate sobre esse jogo neste episódio, damos nossos palpites para a temporada da Premier League. 1:00 Supercopa em Wembley: bastidores e análise em Londres 32:00 Palpites para temporada: Top 6, rebaixados, artilheiro e técnico demitido 56:00 Quiz KTO: João x Senise 1:05:00 Chelsea: montando um belo time 1:10:00 Man City: como chega o time? 1:12:00 Championship 1:15:00 Resenha com barman no pub Learn more about your ad choices. Visit podcastchoices.com/adchoices
Edgard Maciel de Sá, Cauê Rademaker, Phill e Gustavo Garcia analisam a classificação contra o Internacional, a estratégia de Renato no empate e as atualizações do mercado de transferências. DÁ O PLAY!
Bem amigos do Pelada na Net, chegamos em definitivo para o 8 e a faixa! E hoje o Príncipe Vidane comenta o Brasil campeão da Copa América de futebol feminino após mais uma partida lendária da rainha Marta.Esse é um spin-off do Pelada na Net, e está disponível em vídeo no Spotify!site https://peladananet.com.br | bsky @peladananet.com.br | twitter @PeladaNET | instagram @PeladaNaNet | grupo no telegram https://t.me/padegostosodemaisSiga os titulares:Maidana – Twitter / Instagram / BskyShow do Vitinho – Twitter / Instagram / BskyPríncipe Vidane – Twitter / Instagram / BskyProjetos paralelos:Dentro da Minha CabeçaReinaldo JaquelineFábrica de FilmesContribua com o Peladinha:Apoia.sePatreonChave pix: podcast@peladananet.com.br
No NerdCast de hoje vamos falar sobre a onda de reboots no cinema, séries e até games: vale a pena? Bora conversar sobre continuações que surpreenderam, reboots que ninguém pediu e quando é que a gente realmente precisa de algo novo. A PRÓPRIA CARNE Trailer Oficial de A Própria Carne: https://youtu.be/qg5ibXsMG9Y Cadastre-se e acompanhe as novidades: https://jovemnerd.page.link/A_Propria_Carne_Tour Atenção! Estamos nos preparando para o lançamento de A Própria Carne e queremos saber: de qual estado e cidade você gostaria de assistir ao filme? https://docs.google.com/forms/d/e/1FAIpQLScyabqbGvNJHqFp7VR-Z9Bi5QJo-SVc0DVnbiz48apxbNdZkw/viewform NERDSTORE Confira os lançamentos das novas camisetas da NerdStore: https://nerdstore.page.link/Lancamentos_NerdStore_NerdPlayer LUIZALABS Ouça o Nerd na Cloud deste mês: https://jovemnerd.com.br/podcasts/nerd-na-cloud/design-de-ux-inteligente-faz-o-usuario-inteligente/ Instagram @Luizalabs: https://jovemnerd.page.link/Luiza_Labs_Instagram_NC Página de Carreiras: https://jovemnerd.page.link/Carreiras_Magalu_Nerdcast Let's Labs: https://jovemnerd.page.link/Lets_Labs_NerdCast CAVERNA DO DRAGÃO: O EPISÓDIO PERDIDO Confira o curta Ganhador do Leão de Ouro em Cannes 2025: https://youtu.be/m_mFdMVKHTs > SIGA O NOVO FEED DO CANECA DE MAMICAS < CONFIRA OS OUTROS CANAIS DO JOVEM NERD E-MAILS Mande suas críticas, elogios, sugestões e caneladas para nerdcast@jovemnerd.com.br APP JOVEM NERD: Google Play Store | Apple App Store ARTE DA VITRINE: Randall Random Baixe a versão Wallpaper da vitrine EDIÇÃO COMPLETA POR RADIOFOBIA PODCAST E MULTIMÍDIA