Podcasts about regulatory

In this episode, Brenna T. Loufek, Director of AI Regulatory and Quality at Mayo Clinic, discusses how the organization safely translates AI innovations into clinical practice. She explains governance frameworks, ethical considerations, and strategies for deploying AI tools to support both administrative efficiency and clinical decision-making while maintaining trust and patient safety. - The views expressed are Brenna's personal views, and do not necessarily reflect the policy or position of Mayo Clinic.

Over subsequent Parliaments, ACT has tried to pass a version of the Regulatory Standards Bill — with limited success, until now. Deputy Prime Minister and Regulation Minister David Seymour explains how he thinks the bill will work. Q+A questions him about his selection of principles, whether the Government follows its own ideas of good regulation, and some legal uncertainties created by the bill. . As Associate Education Minister, Seymour is leading work on setting up charter schools. But the demand for state schools to undergo conversion to charter has been lower than expected. Jack Tame asks Seymour why. . Join Jack Tame and the Q+A team and find the answers to the questions that matter. Made with the support of NZ on Air.

EDITORIAL: Regulatory failure at the DENR | Nov. 23, 2025Subscribe to The Manila Times Channel - https://tmt.ph/YTSubscribeVisit our website at [https://www.manilatimes.net](https://www.manilatimes.net/)Follow us:Facebook - https://tmt.ph/facebookInstagram - https://tmt.ph/instagramTwitter - https://tmt.ph/twitterDailyMotion - https://tmt.ph/dailymotionSubscribe to our Digital Edition - https://tmt.ph/digitalCheck out our Podcasts:Spotify - https://tmt.ph/spotifyApple Podcasts - https://tmt.ph/applepodcastsAmazon Music - https://tmt.ph/amazonmusicDeezer: https://tmt.ph/deezerStitcher: https://tmt.ph/stitcherTune In: https://tmt.ph/tunein#TheManilaTimes#VoiceOfTheTimes Hosted on Acast. See acast.com/privacy for more information.

Mining Stock Daily welcomes Jon Cherry, CEO of Perpetua Resources, to discuss the strategically important Stibnite Gold Project in Idaho. Stibnite is advancing as a critical mineral supplier while simultaneously committing to the responsible restoration of a long-neglected mining district. The project holds the United States' only SK 1300 published reserve of antimony, a critical mineral the U.S. currently relies on from foreign sources. Antimony is vital for national defense, as the Stibnite project is expected to supply about 35% of the U.S. demand, including crucial antimony trisulfide for military munitions. Cherry details the project's recent milestones, including receiving the federal record of decision and the final 404 wetlands permit, allowing the company to break ground on construction about a month ago. The CEO unpacks the monumental $255 million financing package, featuring investments from Agnico Eagle and JP Morgan Chase, highlighting that Perpetua was the inaugural recipient of the latter's Strategic Resilience Initiative funding. The discussion also covers the current lack of downstream processing capacity in the U.S. for the antimony concentrate and ongoing exploration efforts targeting gold, antimony, and tungsten. This episode of Mining Stock Daily is brought to you by... Revival Gold is one of the largest pure gold mine developer operating in the United States. The Company is advancing the Mercur Gold Project in Utah and mine permitting preparations and ongoing exploration at the Beartrack-Arnett Gold Project located in Idaho. Revival Gold is listed on the TSX Venture Exchange under the ticker symbol “RVG” and trades on the OTCQX Market under the ticker symbol “RVLGF”. Learn more about the company at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠revival-dash-gold.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Vizsla Silver is focused on becoming one of the world's largest single-asset silver producers through the exploration and development of the 100% owned Panuco-Copala silver-gold district in Sinaloa, Mexico. The company consolidated this historic district in 2019 and has now completed over 325,000 meters of drilling. The company has the world's largest, undeveloped high-grade silver resource. Learn more at⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠https://vizslasilvercorp.com/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Equinox has recently completed the business combination with Calibre Mining to create an Americas-focused diversified gold producer with a portfolio of mines in five countries, anchored by two high-profile, long-life Canadian gold mines, Greenstone and Valentine. Learn more about the business and its operations at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠equinoxgold.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Integra Resources is a growing precious metals producer in the Great Basin of the Western United States. Integra is focused on demonstrating profitability and operational excellence at its principal operating asset, the Florida Canyon Mine, located in Nevada. In addition, Integra is committed to advancing its flagship development-stage heap leach projects: the past producing DeLamar Project located in southwestern Idaho, and the Nevada North Project located in western Nevada. Learn more about the business and their high industry standards over at integraresources.com

Labour says the Government shouldn't be celebrating record high prisoner numbers. Earlier this week Prime Minister Christopher Luxon declared it was a good thing the prison population was nearing 11 thousand people. The Government is also celebrating a reduction by 38 thousand in the number of victims of violent crime since it came into power. Labour's Duncan Webb told John MacDonald that while locking people up may provide short term relief, it doesn't last. He says they eventually get out and will cause more harm unless they've been rehabilitated. National's Matt Doocey told MacDonald that he disagrees with Webb framing the situation as locking them up, but not fixing anything. He says you can actually do both, and there is a duty to ensure there are rehabilitation programmes for incarcerated individuals. LISTEN ABOVE See omnystudio.com/listener for privacy information.

With the federal government back up and running, NPC CEO Kam Quarles and COO Mike Wenkel called into the Eye on Potatoes podcast this week to discuss the National Potato Council's top priorities for the next two months and provide updates on key labor and environmental regulatory efforts. Join us as we take a deep dive into: Congressional priorities now that the government is reopened; key recommendations of the Specialty Crop Farm Bill Alliance for the new Farm Bill; the outlook and critical deadlines for emergency relief programs for growers; and top legislative and appropriations priorities, including securing funding for research and market development.Mike will also provide updates on the regulatory environment, covering: the potential impacts of the Department of Labor's new two-level wage structure for the H-2A program; and the benefits of the new EPA WOTUS proposal, specifically the clarity on excluding certain ditches.

The coalition is in the throes of internal warfare - with Winston Peters and David Seymour slinging barbs over the Regulatory Standards Bill. In a stunning about-face today, Mr Peters has pledged to revoke that law - ACT's brainchild - next term - despite voting it through last week. It has prompted an extraordinary rebuke from David Seymour - who says Mr Peters looks like he's gearing up to jump ship to a Labour coalition. Acting political editor Craig McCulloch spoke to Lisa Owen.

Winston Peters says the Coalition is doing just fine after his change of position on ACT's Regulatory Standards Bill. The NZ First Leader says next year he will campaign on getting rid of the legislation, despite supporting it just last week. ACT Leader David Seymour finds that worrying. But Peters told Mike Hosking he rejects any claim the Coalition is crumbling. He says their number one responsibility is providing a stable Government, which it is doing. LISTEN ABOVE See omnystudio.com/listener for privacy information.

David Seymour isn't impressed with New Zealand First's promise to campaign on repealing ACT's Regulatory Standards bill. The Bill passed last Thursday - supported by New Zealand First, National and ACT - and became law two days ago. NZ First leader Winston Peters has since called it a 'terrible overreach' and 'not fit for a modern democracy'. Seymour gave his opinion on this move. "People want to play politics - I mean, it's not even an election year yet." LISTEN ABOVESee omnystudio.com/listener for privacy information.

When Martha Otton announced in the summer of 2024 that she was retiring as Executive Director of iGaming Ontario, there was thinking among different sectors of the province's regulated igaming market that the organization's Chief of Staff, Mitch Davidson, would be a great fit to move into the leadership role. Instead, Davidson decided in August to get back into the policy game, this time as Vice President, Policy for Canadian public affairs firm Enterprise Canada. The former Director of Policy for the Premier's Office was our guest on the latest episode of the Gaming News Canada Show presented by Bede Gaming. Your humble host tried to cover with the new father the gamut of topics in the business of sports betting and online gaming, Canadian style, including: Davidson's decision, after speaking with some gaming-related businesses, to join Enterprise;The work done at iGO under the leadership of Otton and him to launch Ontario's open private-sector market in April 2022, and the success story that is the Ontario model;Why the implementation of a centralized self-exclusion program, identified as a priority by operators, has taken so long (new iGO president and CEO Joseph Hiller told us on the GNCS at the beginning of the month he expects the program to be launched in the first half of 2026);Other priorities for iGO moving forward;His reaction to last week's decision by the Court of Appeal for Ontario to go along with reviving pay-to-play daily fantasy contests and expanding online poker games (Davidson writes about the court ruling and liquidity in his latest post on The Policy Shop);What happens with regulated gaming beyond Ontario, including Alberta. Davidson also explained the motivation for the creation of The Policy Shop on Substack, a weekly, well-reasoned deep dive into the issues that matter most to Canadians these days and – importantly - offering potential solutions. Hosted on Acast. See acast.com/privacy for more information.

In dieser Folge sprechen Katrin Repic (Counsel bei DORDA im Bereich Banking & Regulatory) und Philipp Stadtegger (DORDA-Rechtsanwalt im Bereich Dispute Resolution und Co-Head für White-Collar Crime) über das komplexe Thema Geldwäscherei. Katrin erklärt die Grundlagen und aktuelle Beispiele wie „Money Mules“, während Philipp den Straftatbestand nach § 165 StGB und Gefahren für Zahlungsempfänger beleuchtet. Außerdem geht es um die aktuelle FATF-Prüfung, bei der Österreich momentan beinahe auf der gleichen Stufe wie Kongo und Syrien steht, und um die ernüchternde Bilanz im Kampf gegen Geldwäsche: weniger als 0,1 % der illegalen Geldströme werden unterbunden. Ein aufschlussreiches Gespräch über Risiken, Lücken und notwendige Reformen im Kampf gegen schmutziges Geld.

Let's talk asset management: Episode 21 – AI in asset management: regulatory risks and opportunities by NRF Regulation Tomorrow Podcast

Today, we're hopping back into the archive and revisiting an episode with Gerard Barron, the co-founder, CEO, and chairman of The Metals Company, who joined us to discuss the company's plans to harvest critical metals off the sea floor.  Summary:The Trump administration has made American reindustrialization a top priority, but to do that, the US is going to need access to an abundance of metals like copper, manganese and nickel. The challenge then is to find a way to source these materials that doesn't rely on Chinese supply chains, and won't lead to serious environmental harm.Gerard Barron is the co-founder, CEO and chairman of The Metals Company, which trades on the Nasdaq under the symbol TMC. The Metals Company mission is to harvest and process metal-containing nodules from the sea floor, providing a clean and abundant source of raw materials for an array of critical industries, like steelmaking and EV production. Gerard walks us through the evolution of TMC, their groundbreaking tech, and some recent regulatory breakthroughs that have brought them closer to achieving their goals than ever before.Highlights:The Metals Company Mission (2:07)The history of seabed harvesting (3:43)Land-based supply chains (7:17)TMC's tech (10:44)Regulatory roadblocks (12:28)Defense implications (15:51)EVs (17:37)Korea Zinc deal (19:41)Looking ahead (21:34)PE Involvement (24:22) Links:Gerard's LinkedInThe Metals Company LinkedInThe Metals Company WebsiteICR LinkedInICR TwitterICR Website Feedback:If you have questions about the show, or have a topic in mind you'd like discussed in future episodes, email our producer, Joe@lowerstreet.co.

In this episode, we sit down with Dr. William Ho, President, CEO, and Co-Founder of IN8 Bio — a pioneering biotech company developing next-generation Gamma Delta T cell therapies for both solid and hematologic cancers.From Wall Street to the biotech lab, Dr. Ho shares his remarkable journey and how he's leveraging artificial intelligence, data analytics, and computational biology to reshape cell therapy development, manufacturing, and scalability.Discover how AI is transforming every stage of biotech — from drug discovery and clinical trial optimization to manufacturing automation and investor relations — and why Dr. Ho believes it's key to achieving IN8 Bio's mission of Cancer Zero.Key HighlightsFrom finance to pharma: How Dr. Ho's Wall Street experience shaped his approach to building a public biotech company.AI in biotech innovation: Real-world examples of using natural language processing and machine learning to uncover drug-development gaps.Data-driven discovery: How IN8 Bio uses AI, RNA Seq, and single-cell analysis to advance Gamma Delta T cell therapies.Smarter manufacturing: The role of AI and LLMs in optimizing cell-therapy production, reducing costs, and managing global supply chains.Regulatory readiness: How biotech companies can navigate FDA compliance while integrating AI tools.Capital markets & biotech: Why the next generation of investors discover biotech companies on TikTok — and how IN8 Bio adapts to the algorithmic market.Mission Cancer Zero: How AI will help achieve a future where no patient dies of cancer.About the PodcastAI for Pharma Growth is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.This show brings together leading experts and changemakers to demystify AI and show how it's being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI's role in social good, this podcast offers valuable insights.AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget. As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses. This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so much more. Dr. Andree Bates LinkedIn | Facebook |

In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kaitlin Maier.

Recently, the controversial Regulatory Standards Bill passed its third and final reading. The bill has raised concerns amongst many for a variety of reasons, including its lack of recognition of Te Tiriti o Waitangi, the risks it poses to the environment, and what opponents say is its ‘narrow neoliberal framework'. The bill, during public submissions, received 156,000 submissions, with over 98% voicing their opposition to the proposed legislation. News and Editorial Director Joel spoke to Geoffrey Bertram, a visiting scholar and retired lecturer at the Victoria University of Wellington about the bill, why it is so polarising, and what the passing of this bill means heading forward.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a host of transformative events reshaping the landscape, from strategic acquisitions and funding infusions to regulatory maneuvers and scientific breakthroughs.Johnson & Johnson has taken a decisive step in its oncology strategy with the $3 billion acquisition of Halda's cell death technology. This acquisition, focusing on the "hold and kill" bifunctional small molecule platform, is poised to enhance J&J's prostate cancer pipeline significantly. It underscores J&J's commitment to expanding its oncology portfolio through innovative platforms designed to improve therapeutic outcomes. The move highlights a broader industry trend toward personalized medicine and targeted cancer therapies, which are becoming pivotal in improving patient care.In another domain of cancer treatment, Nuvalent has unveiled promising Phase 1/2 data for its candidate neladalkib, which could position the company as a formidable competitor to Pfizer's established lung cancer drug, Lorbrena. The promising data might expedite regulatory discussions with the FDA, potentially leading to an accelerated approval process. This development illustrates the competitive landscape in oncology, where firms strive to introduce novel therapies with improved efficacy and safety profiles.The field of antibody-drug conjugates (ADCs) is also experiencing significant advancements. A San Diego-based biotech has secured $120 million in funding to develop a best-in-class ADC formula, with support from Merck & Co. This initiative aims to refine the precision and efficacy of ADCs by delivering cytotoxic agents directly to cancer cells while minimizing collateral damage to healthy tissues. Such innovations are crucial as they represent a new frontier in targeted cancer therapy.In terms of financial activities, Artios Pharma's successful $115 million Series D funding round is set to bolster its clinical efforts in exploring DNA damage response inhibitors for cancer treatment. These inhibitors target cancer cells' ability to repair DNA damage, holding potential for more effective therapies against resistant cancer types. Meanwhile, Sofinnova Partners' €650 million raise for biotech and medtech investments amid a volatile economic environment underscores continued investor confidence in life sciences despite market uncertainties.Bayer is making strategic moves in China by opening an incubator in Beijing. This facility will host local biopharma companies such as Suzhou Puhe Biopharma and Beijing Youngen Technology, fostering innovation and collaboration within China's burgeoning biotech landscape. Such initiatives reflect global efforts to leverage regional strengths and foster cross-border collaborations.On the operational side, Nxera Pharma is restructuring its workforce by laying off 15% of its staff as part of a strategic pivot towards profitability. This decision mirrors broader industry trends where companies refocus resources on core projects to streamline operations and enhance financial stability.A recent study has highlighted the impact of NIH grant cuts on clinical trials across the United States. Over 383 trials involving more than 74,000 patients have been disrupted due to funding terminations under the current administration. This situation raises concerns about the sustainability of clinical research funding and its implications for ongoing medical advancements.Jazz Pharmaceuticals has reported practice-changing Phase 3 results for its HER2-targeted drug Ziihera for gastroesophageal adenocarcinoma. These findings reaffirm Jazz's confidence in positioning Ziihera as a preferred first-line treatment option for HER2-positive cancers, poSupport the show

This three-part podcast explores how Medical Affairs leaders can navigate and lead through disruption with clarity, structure, and resilience.We explore how to construct and lead an agile, cross-functional crisis team. From defining roles to ensuring aligned decision-making across Medical, Regulatory, and Commercial functions, this episode emphasizes rapid coordination, internal trust, and shared accountability under pressure.

This episode of iGaming Daily explores why Europe is preparing to introduce stricter gambling regulations in 2025. Host Charlie Horner is joined by Ted Menmuir, SBC Media's Editor-at-Large, and iGaming Expert's Editor, Joe Streeter, to unpack major regulatory shifts across two key markets: Italy and Romania.The team first examines Italy's overhaul of its online gambling industry, driven by Prime Minister Giorgia Meloni's government. Central to the reform is a significantly higher entry barrier, with a new nine-year concession priced at €7 million, resulting in fewer available licences. Italy aims to streamline the sector, strengthen oversight, phase out the fragmented skins model, and position itself as Europe's most secure and tightly regulated market. The episode also touches on new compliance requirements, including mandatory digital ID verification for player account registration.Attention then shifts to Romania, where the Liberal Party is pushing to increase the legal gambling age from 18 to 21. The guests debate whether this measure meaningfully enhances player protection, especially given the stark contrast between Romania's relatively volatile regulatory landscape and Italy's push for structured control.This episode is supported by Optimove, the creator of positionless marketing and the leading player engagement platform.Host: Charlie HornerGuests: Ted Menmuir & Joe StreeterProducer: James RossEditor: James RossiGaming Daily is also now on TikTok. Make sure to follow us at iGaming Daily Podcast (@igaming_daily_podcast) | TikTok for bite-size clips from your favourite podcast. Finally, remember to check out Optimove at https://hubs.la/Q02gLC5L0 or go to Optimove.com/sbc to get your first month free when buying the industry's leading customer-loyalty service.

Recently, the controversial Regulatory Standards Bill passed its third and final reading. The bill has raised concerns amongst many for a variety of reasons, including its lack of recognition of Te Tiriti o Waitangi, the risks it poses to the environment, and what opponents say is its ‘narrow neoliberal framework'. The bill, during public submissions, received 156,000 submissions, with over 98% voicing their opposition to the proposed legislation. News and Editorial Director Joel spoke to Geoffrey Bertram, a visiting scholar and retired lecturer at the Victoria University of Wellington about the bill, why it is so polarising, and what the passing of this bill means heading forward.

In this episode, our host sits down with Gary Plant, PeerNova's Valuation Risk Leader and Subject Matter Expert (SME),  to explore what true regulatory readiness looks like in today's fast-moving valuation risk landscape. Uncover why traditional monthly or quarterly IPV cycles no longer meet regulatory expectations, how fragmented infrastructures slow firms down, and why valuation teams need more transparent, agile, and scalable controls to keep pace.Learn how Cuneiform® for Valuation Risk helps firms modernize IPV, achieve real-time oversight, reduce human middleware, and deliver audit-ready transparency across the valuation lifecycle.Gary answers the following questions:What are the biggest challenges firms face in achieving regulatory readiness for valuation risk? How are regulators pushing firms toward daily (or real-time) valuation oversight?What structural and operational barriers prevent modernization?Why do firms need a single, strategic solution to meet increasing demands and reduce manual processes?How does Cuneiform® for Valuation Risk address these challenges with real-time execution, transparency, and compliance alignment?

The Centers for Medicare & Medicaid Services (CMS) recently released the 2026 Medicare Physician Fee Schedule. And while that's not breaking news, the important news is that you and your team could benefit by understanding its hidden traps – so you can protect your revenue. During the next live edition of Monitor Monday, senior healthcare analyst Frank Cohen will reveal the latest developments in Medicare audit reforms and statistical extrapolation, including the Medicare Program Integrity Manuel (MPIM) standards, plus how artificial intelligence (AI) is changing audit selection for 2025.You and your team will receive expert analysis and practical guidance, as well as gain a better understanding of the true scope of improper payments.The weekly broadcast will also include these instantly recognizable features:Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.Legislative Update: Adam Brenman, senior healthcare legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a myriad of pivotal changes and advancements that have been shaping our industry.The competitive nature of acquisitions within the biopharma sector has been exemplified by recent strategic buyouts. Lundbeck's decision to outbid Alkermes for Avadel Pharmaceuticals highlights how companies are leveraging acquisitions to expand their capabilities and portfolios. Similarly, Pfizer's finalized acquisition of Metsera after a fierce bidding war with Novo Nordisk underscores the importance of securing valuable assets to strengthen positioning in critical therapeutic areas, such as obesity treatment, where demand continues to rise.Regulatory milestones remain at the heart of industry progress. Organon and Henlius's Poherdy recently received FDA approval as a biosimilar to Roche's Perjeta, offering a new treatment avenue for HER2-positive breast cancer patients. This approval is noteworthy as biosimilars play an essential role in oncology by providing similar efficacy to original biologics but at reduced costs, thereby enhancing healthcare affordability and accessibility. In Europe, the EMA's Committee for Medicinal Products for Human Use has endorsed several innovative drugs, including Otsuka's Dawnzera for hereditary angioedema and Lilly's Inluriyo for certain cancer types. These endorsements reflect the growing pipeline of treatments addressing both rare genetic disorders and widespread diseases.Merck & Co.'s acquisition of Cidara Therapeutics for $9.2 billion underscores a strategic pivot towards bolstering its antiviral portfolio. This deal is particularly significant given Cidara's promising influenza antiviral candidate, initially abandoned by Johnson & Johnson. In an era where infectious diseases pose ever-evolving challenges, Merck's investment in antivirals reflects a commitment to advancing therapeutic solutions in this crucial area.However, drug development's inherent uncertainties were highlighted by Bristol Myers Squibb and Johnson & Johnson's joint anticoagulant venture, which faced termination due to a Phase 3 trial failure. This setback emphasizes the challenges and risks entailed in developing novel therapeutics, particularly within high-stakes areas like cardiovascular health.Leadership changes can significantly impact corporate strategy, as seen with Bavarian Nordic following an unsuccessful private equity takeover attempt. Such shifts can influence investor confidence and reshape strategic directions.Investment trends also paint an optimistic picture for innovation within the sector. European life sciences investor Medicxi's successful raising of €500 million signifies robust financial support for biotech ventures. This influx of capital is vital for propelling early-stage research and development efforts across Europe, fostering breakthroughs in chronic and rare disease treatments.In terms of scientific innovation, advancements in bispecific antibody production through AI/ML-driven molecular design promise higher yields and enhanced quality. These technological innovations could revolutionize complex biologics manufacturing, potentially accelerating timelines and expanding therapeutic possibilities.The regulatory landscape is seeing significant activity as well. Notably, FDA officials introduced a novel pathway aimed at accelerating gene editing therapies' development and approval. By facilitating faster market entry for personalized medicines, this regulatory innovation could pave the way for treatments tailored to individual genetic profiles.Kyowa Kirin's collaboration with Kura Oncology reached a milestone with FDA approval for an oral medication targeting acute myeloidSupport the show

In this episode, Brenna T. Loufek, Director of AI Regulatory and Quality at Mayo Clinic, discusses how the organization safely translates AI innovations into clinical practice. She explains governance frameworks, ethical considerations, and strategies for deploying AI tools to support both administrative efficiency and clinical decision-making while maintaining trust and patient safety. - The views expressed are Brenna's personal views, and do not necessarily reflect the policy or position of Mayo Clinic.

Last Week, the government passed the regulatory standards bill into the regulatory standards act. Long controversial, failing to pass in its first three readings and subject to enormous opposition in submissions during the process, the law is the child of David Seymour's ACT party.   But now that this law has passed, these serious concerns are of urgency. Particularly there are loud concerns and criticisms of the primacy granted to corporate interests, in the face of te Tiriti o Waitangi and the environment. Monday Wire Producer Alex spoke to Greenpeace Campaigner Gen Toop about the bill passing, what it means for the environment, and what should be done in the face of this policy threat.  

A few weeks ago, Kelston Boys High School in West Auckland said they were at the front of an unsupported, attempted takeover to turn the school into a charter school. As well as this, more recently, the New Zealand Campus of Innovation and Sport, a charter school set to be established next year, was signed with a trust that did not exist. Amendments have also been made to the Education and Training Act, removing a clause requiring school boards give effect to Te Tiriti o Waitangi. The move has seen backlash from the National Iwi Chairs Forum and a growing number of schools, who have launched a petition against the move.  Finally, the controversial Regulatory Standards Bill has passed its third reading and is now set to be implemented into law. The bill previously received 156,000 public submissions, with 98.7% of those voicing their opposition to the bill. For our weekly catch-up with ACT Party's Simon Court, News and Editorial Director and Monday Wire Host Joel spoke to him about these topics. They started off by asking Court about Kelston Boys High School and the New Zealand Campus of Innovation and Sport, and how concerning these developments are for the ACT Party.

In this conversation, Stephan Livera and Carel Van Wyk discuss the evolution of Bitcoin as a medium of exchange, focusing on the role of MoneyBadger in facilitating Bitcoin payments across South Africa. They explore the journey of integrating Bitcoin payments into major retailers, the technological innovations that have made this possible, and the implications for merchants and consumers alike. The discussion also touches on the broader context of Bitcoin's role in the global payment landscape and the ongoing debate about its function as a store of value versus a medium of exchange. They explore the economic challenges faced by South Africans, the regulatory landscape, and the importance of demonstrating Bitcoin as a medium of exchange. The discussion also touches on the implications of capital gains tax, the strategies for promoting Bitcoin adoption, and the potential for Bitcoin to serve as a viable alternative to traditional payment systems. Carel emphasizes the urgency of using Bitcoin as money and the need for a shift in mindset among both consumers and regulators.Takeaways:

We're going to start today's show talking about the Regulatory Standards Bill -which has now passed its third reading in Parliament. Despite more than 98% of public submissions opposing the bill, it sailed through with the backing of all three coalition parties. That means it's now set to be signed in to law by the Governor-General. But what actually is the regulatory standards bill? It feels like there has been a lot of commentary from people for and against the bill .. but we wondered how many of you actually know what it will do? RNZ Political Reporter Russell Palmer joins Jesse.

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In this episode, we discuss CIMA surveys, frozen assets reporting, the VASP regulatory forum, year-end reminders, and Cayman FSPs – preparing for the FATF fifth-round review.SPEAKERS:Adam Huckle, Partner | +1 345 814 5318 | adam.huckle@maples.com | View bioAnthony Mourginos, Partner | +1 345 814 5155 | anthony.mourginos@maples.com| View bioJo Ottaway, Associate | +1 345 814 5511 | jo.ottaway@maples.com | View bioRESOURCES:Visit our Regulatory Round-Up Blog for the latest developments and insights in the regulatory landscapeRELATED SERVICES:Maples Group Regulatory and Financial Services AdvisoryWith a depth of experience across all regulated sectors, the Maples Group Regulatory and Financial Services team is positioned to address client needs and sensitivities. We have the largest dedicated Cayman Islands Regulatory and Financial Services team in the offshore market.Follow Us: LinkedIn: https://www.linkedin.com/company/maplesgroup/Instagram: https://www.instagram.com/maplesgroup/Twitter: https://twitter.com/maplesgroupFacebook: https://www.facebook.com/maplesgroup/Website: https://maples.com/podcasts/15-15 Blog: https://maples.com/regulatory-round-up

It's fourth time lucky for ACT, with the Regulatory Standards Bill finally passing into law. The party has brought versions of the bill to parliament three times since 2006. Otago University law Professor Andrew Geddis spoke to Corin Dann.

The Regulation Minister says a small number of groups have hijacked the public submission process. ACT's Regulatory Standards Bill has passed its third reading at Parliament. The policy, which provides principles for lawmaking, received 156-thousand public submissions – 98% of those opposed. David Seymour told Mike Hosking there have been more select committee submissions in the past two years than in the history of Parliament. He says organisations like Greenpeace spread mistruths and automate submissions for people. LISTEN ABOVE See omnystudio.com/listener for privacy information.

In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Somer Baburek.

Itay Goldstein, Wharton Professor of Economics and Finance, analyzes Coinbase's $375 million acquisition of blockchain capital-raising platform Echo, exploring how reduced regulatory uncertainty, renewed interest in Initial Coin Offerings, and innovations like stablecoins are influencing the next stage of crypto market evolution. Hosted on Acast. See acast.com/privacy for more information.

MedBoard   EU Joint clinical assessment procedure -  EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone.   Team-NB proposal for MDR & IVDR - 5 topics on the agenda:  https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR:  SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download   PODCAST Podcast review -  What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh:  https://podcast.easymedicaldevice.com/361-2/

Send us a textGood morning from Pharma Daily, the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of groundbreaking changes and innovations reshaping the landscape of drug development, clinical trials, and regulatory affairs.In a major move, Pfizer has successfully outbid Novo Nordisk to acquire Metsera for $10 billion. This strategic acquisition aims to bolster Pfizer's presence in the obesity treatment market by leveraging Metsera's GLP-1 receptor agonist technology. This acquisition underscores the continuing trend of consolidation within the pharmaceutical industry, enhancing competitive market positioning and reflecting a broader quest for novel therapeutic solutions.Eli Lilly has entered into a $1.2 billion collaboration with Sangenebio to advance RNA interference (RNAi) therapeutics targeting metabolic diseases. This partnership marks a pivotal shift towards utilizing RNAi technology to silence disease-causing genes, representing significant progress in metabolic disease treatment. The focus on innovative delivery mechanisms and targeted interventions is critical for accelerating drug development and enhancing therapeutic efficacy.Onchilles Pharma's recent Series A1 funding round, securing $25 million, marks a notable advancement in oncology therapeutics. The company's focus on dual-action cancer biologics targeting the ELANE pathway offers promising insights into immune activation in solid tumors. This investment exemplifies the growing interest in biologic therapies that provide targeted cancer treatments, potentially leading to more effective options for patients.Regulatory advancements are also making headlines. Chongqing Precision Biotech has received approval for Pujiolunxi, a treatment for pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), broadening therapeutic options for this challenging pediatric condition. Furthermore, Alembic Pharmaceuticals' generic version of Dasatinib tablets has gained FDA approval for Philadelphia chromosome-positive chronic myeloid leukemia, increasing accessibility to treatment.Several promising clinical trial results have emerged recently. Summit Therapeutics and Akeso Biopharma's Ivonescimab showed a 26% overall survival benefit in phase 3 trials for non-small-cell lung cancer. The potential of bispecific antibodies in combination therapies is gaining attention for its efficacy in difficult-to-treat cancers. Additionally, Regeneron's Dupixent has achieved phase 3 success in treating allergic fungal rhinosinusitis, reinforcing its role as a versatile treatment option across various inflammatory diseases.Advancements in cardiovascular therapeutics also continue to unfold. Merck & Co.'s Enlicitide Decanoate demonstrated over 50% LDL cholesterol reduction in a phase 3 study focused on atherosclerotic cardiovascular disease through PCSK9 inhibition. AstraZeneca's Baxdrostat showed significant blood pressure reduction in trials targeting treatment-resistant hypertension, highlighting the potential impact of aldosterone synthase inhibitors on cardiovascular health.The investment landscape remains robust with substantial fundraising activities such as Elephas Biosciences' $40 million Series B-2 for commercializing their live tumor profiling platform and Iambic's over $100 million series focused on AI-driven drug discovery. These investments underscore the industry's commitment to integrating advanced technologies like AI and live tumor profiling to enhance precision medicine capabilities.FDA regulatory updates are pivotal as well, notably with the decision to lift warning labels from hormone replacement therapy (HRT) products following an expert review that found previous warnings were based on misinformation regaSupport the show

In this episode of Econ 102, Noah Smith and Erik Torenberg explore AI's effects on productivity, how AI business models will shake out, the US and China's rare earth minerals industries, and China's economic challenges, including demographics, real estate, and involution.-Sponsors:NotionAI meeting notes lives right in Notion, everything you capture, whether that's meetings, podcasts, interviews, conversations, live exactly where you plan, build, and get things done.  Here's an exclusive offer for our listeners. Try one month for free at ⁠https://www.notion.com/lp/econ102⁠NetSuiteMore than 42,000 businesses have already upgraded to NetSuite by Oracle, the #1 cloud financial system bringing accounting, financial management, inventory, HR, into ONE proven platform. Download the CFO's Guide to AI and Machine learning: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://netsuite.com/102⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Found Found provides small business owners tools to track expenses, calculate taxes, manage cashflow, send invoices and more. Open a Found account for free at https://found.com/econ102-Shownotes brought to you by Notion AI Meeting Notes - try one month for free at https://www.notion.com/lp/econ102⁠AI can affect productivity in multiple ways: replacing humans, enhancing human productivity, creating new tasks, and increasing capital productivityAI may follow other essential industries with low profit margins despite creating enormous value:Like farming, solar power, and airlinesCode-related AI applications are seeing particularly strong adoptionVertical AI applications in specific industries (healthcare, legal, real estate) are gaining tractionChina controls the majority of rare earth mining and refiningThe US has sufficient rare earth deposits but faces two challenges:Regulatory barriers to miningLack of solvent extraction technology and know-howChina's fertility rate is lower than Japan and EuropeHowever, a "baby bulge" (ages 7-22) will support the workforce short-term-Timestamps:00:00 — Intro00:52 — AI's impact on productivity02:27 — Debating whether AI will increase productivity03:11 — Historical analogy: Electricity's impact on productivity, lessons for AI07:55 — Sponsors: Notion | Netsuite09:57 — Application layer companies, AI in coding, vertical AI applications12:49 — AI bubble vs. CapEx boom/bust, historical parallels (railroads, telecoms)16:54 — Brand loyalty, price wars, and profitability in AI models22:26 — US-China trade, rare earths, and supply chain challenges32:20 — Sponsor: Found33:33 — China's demographic and economic challenges, over-competition, and deflation54:06 — Recommendations for China's economic policy, rationalizing the economy-FOLLOW on X:https://x.com/eriktorenberghttps://x.com/Noahpinion-Please note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details, please see a16z.com/disclosures. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Land owners have a lot to consider and the environmental condition of their property is a big one. There are more and more regulatory and compliance requirements - and if you have an issue, you need to know who to call for help. Joining me to share the services provided by Hamp Mathews & Associates are their Principal Engineer and Visionary, Joel Parker, and Office Manager and Integrator Holly Petroff!

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's rapidly evolving landscape, we witness significant strides shaping the future of drug development, patient care, and global market dynamics.Merck & Co. has made a notable advancement in cholesterol management with a PCSK9-targeted pill. This pill has achieved reductions in low-density lipoprotein cholesterol (LDL-C) comparable to existing injectable therapies. Such innovation represents a significant step forward by potentially offering a more convenient oral alternative for patients. The development underscores the industry's ongoing efforts to enhance patient compliance and therapeutic outcomes through novel drug delivery mechanisms.In a strategic corporate move, Pfizer has successfully acquired Metsera, an obesity biotech company, for a substantial $10 billion. This acquisition, which followed an intense bidding war with Novo Nordisk, exemplifies Pfizer's aggressive expansion in the obesity treatment market—a growing global health challenge. The strategic buyout positions Pfizer to leverage Metsera's expertise, potentially accelerating the development and commercialization of innovative obesity treatments.Meanwhile, Novo Nordisk is enhancing its presence in India by partnering with Emcure Pharmaceuticals to expand access to Wegovy, its weight-loss treatment. This collaboration is particularly significant given India's escalating obesity rates and highlights the importance of regional partnerships in enhancing drug accessibility and addressing public health issues.Regulatory developments continue to influence industry dynamics as well. The FDA has postponed its decision on expanding Rhythm Pharmaceuticals' Imcivree for additional indications. These regulatory delays highlight the complexities and unpredictabilities inherent in drug approval processes, underscoring the need for companies to strategically navigate these challenges.Regeneron and AstraZeneca have reported clinical trial successes with their respective anti-inflammatory drugs, Dupixent and Fasenra. These positive outcomes were showcased at the American College of Allergy, Asthma, and Immunology's annual meeting, bolstering the companies' aspirations for FDA approvals. Successful clinical outcomes not only pave the way for expanded therapeutic options but also demonstrate the industry's commitment to addressing complex inflammatory conditions.October has seen a surge in TV advertising spending, led by Johnson & Johnson's campaign for Tremfya. The campaign highlights the power of patient community engagement in bringing attention to conditions like inflammatory bowel disease (IBD), emphasizing how patient advocacy can reduce isolation among sufferers.In oncology, Cogent Biosciences is on track for an FDA submission following successful phase 3 trials of its cancer asset bezuclastinib. This development illustrates the critical role of rigorous clinical research in advancing oncology treatments and potentially improving patient outcomes.Turning our attention to technological frontiers within pharmaceutical R&D, Eli Lilly has been particularly active in cementing its commitment to artificial intelligence (AI) and gene therapy through several strategic collaborations. The company has entered into a $100 million-plus research agreement with Insilico Medicine to leverage AI for drug discovery. This partnership aims to expedite the identification of novel therapeutic targets and enhance drug development efficiency—a reflection of a broader industry trend towards integrating AI into pharmaceutical processes.Additionally, Lilly has made a notable move in gene therapy by acquiring rights from MeiraGTx for a retinal disease therapy that has shown Support the show

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation's stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.Key Timestamps[02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show's focus on the China market.[05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.[08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."[11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.[14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.[16:20] Leveraging the Hainan Free Trade Zone (Bo'ao region) for pre-market clinical data collection and urgent needs product access.[18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).[20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.[23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).[25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.[29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.[30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China...

Recently, a new version of the Sequential Organ Failure Assessment (SOFA) score was introduced.Known as SOFA-2, this new definition aligns with organ dysfunction measurement in critically ill adults with current clinical practices, especially those diagnosed with sepsis.Published in the Journal of the American Medical Association (JAMA) on Oct. 29 and available at  https://jamanetwork.com/journals/jama/fullarticle/2840822, this revised tool updates the original 1996 SOFA score, which had remained unchanged despite evolving treatment modalities and technologies. During the next live edition of Monitor Mondays, Dr. James S. Kennedy will discuss this SOFA-2 revision and its expected impact on clinical validation for sepsis – defined by Sepsis-3 as a life-threatening organ dysfunction caused by a dysregulated host response to infection – and how facility clinical workflows can negotiate denial avoidance with payers with this challenging diagnosis.The weekly broadcast will also include these instantly recognizable features:Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.Legislative Update: Cate Brantley, senior healthcare legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of groundbreaking developments that are reshaping the landscape of drug development and patient care. These stories highlight the dynamic nature of the pharmaceutical and biotechnology industries, where scientific advancements and regulatory changes are driving significant shifts.We begin with a crucial milestone in oncology treatment. The FDA has granted approval to Johnson & Johnson's Darzalex Faspro for patients with high-risk smoldering multiple myeloma. This approval is particularly significant as it provides a new therapeutic pathway for individuals with this precursor condition to active multiple myeloma, which previously had few treatment options. The drug works by targeting CD38 proteins on myeloma cells, representing a leap forward in monoclonal antibody treatments for cancer. This decision underscores the FDA's ongoing commitment to expanding treatment options for conditions with high unmet needs, potentially setting a precedent for future approvals in early-stage malignancies.Meanwhile, Gilead Sciences encountered challenges with its oncology pipeline as Trodelvy failed to meet its primary endpoint in a Phase 3 trial for first-line HR+/HER2-negative metastatic breast cancer. This outcome highlights the complexities of oncology drug development, despite previous successes in other indications. Such setbacks remind us of the inherent risks involved in bringing innovative therapies to market.In contrast, Akeso has announced positive data for ivonescimab, a PD-(L)1xVEGF bispecific antibody. The drug demonstrated significant overall survival benefits in patients with previously treated EGFR-mutated non-small cell lung cancer. This advancement underscores the therapeutic potential of bispecific antibodies in cancer immunotherapy, which continue to gain traction as they target multiple pathways involved in tumor growth and immune evasion.Regulatory incentives have also been making waves. The FDA's rollout of the second round of "national priority" voucher winners aims to accelerate drug development timelines, particularly in critical areas such as obesity. Companies like Lilly and Novo Nordisk have been recognized for their efforts, highlighting a broader strategy to bring transformative therapies to market more swiftly.On the corporate front, Bayer's proposed private equity buyout fell through due to insufficient shareholder support, reflecting ongoing financial volatility and strategic recalibrations within biotech firms. Meanwhile, CMS's introduction of a new Medicaid pricing model aims to implement "most-favored nation" pricing strategies to control drug costs, signaling potential shifts in how pharmaceutical companies approach pricing negotiations and reimbursement strategies.Technological advancements are also at the forefront of innovation. Eli Lilly has expanded its AI-driven drug discovery partnership with XtalPi, focusing on antibody development. This collaboration exemplifies how AI is increasingly being integrated into pharmaceutical research to enhance drug discovery processes.Furthermore, China's decision to lift its ban on Illumina's DNA sequencers is expected to facilitate greater access to advanced genomic technologies within the region, fostering innovation in precision medicine.Leadership changes continue to shape industry dynamics. For instance, Recursion Pharmaceuticals is undergoing executive restructuring to better align with evolving market needs and innovation strategies. These changes are crucial for maintaining competitiveness and fostering an environment conducive to scientific breakthroughs.The industry is also witnessing strategic realignmenSupport the show

Concerns have been raised that rough sleepers will be pushed into unfamiliar suburbs outside of Auckland CBD, following government ministers' consideration of new measures. Justice Minister Paul Goldsmith says he had been tasked with making sure police were equipped to halt public disorder. When questioned explicitly about the ban, he said, "We're working our way through those issues... when we've got something to announce, we'll announce that." As well as this, the Regulatory Standards Bill has passed its second reading in Parliament, having seen a few changes made to the bill in the select committee process. The bill, having received 156,000 public submissions, almost 99% in opposition to the bill, is controversial. Constitutional experts and critics of the bill have expressed concerns that the amendments do not address its failings, and the “ideological” way it has been written means that if passed, the bill will have a lasting impact. The bill also lacks references to Te Tiriti o Waitangi. For our weekly catch-up with ACT Party's Simon Court, News and Editorial Director and Monday Wire Host Joel spoke to him about both these topics.

Mike Rost from Workiva (WK) explains what the company does and looks at its latest financial results. Workiva helps other companies with regulatory reporting and compliance. He breaks down the quarter, noting it was a “beat and raise” and they lifted guidance for 4Q. He also discusses how Workiva has implemented AI tools and how customers are using them, as well as how they're keeping sensitive data secure.======== Schwab Network ========Empowering every investor and trader, every market day.Options involve risks and are not suitable for all investors. Before trading, read the Options Disclosure Document. http://bit.ly/2v9tH6DSubscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about

We've heard that Microsoft will go off script this year with a 26H1 release of Windows 11 specifically aimed at Snapdragon X2-based PCs, as it did with the early release of 24H2 last year for the first-generation Snapdragon X. Also, Microsoft's latest earnings call left analysts baffled as execs dodged questions about multibillion-dollar AI losses and the real story behind OpenAI's ballooning deficit.26H1! Now confirmed by the release notes of a Windows Update And the Dev channel will soon switch over to 26H1 testing, with Beta moving to 25H2 (from 24H2) Expectations? All three versions will be functionally identical except for some Copilot+ PC-specific features that may be briefly only on Snapdragon X2. And then there will be a 26H2 for everyone More Windows 11 Microsoft (over) simplifies its Windows Update naming scheme, and then has to backtrack a bit because of admin/IT backlash October Preview Update screwed up Task Manager a little bit Dev/Beta update noted above included a new build with Ask Copilot in the Taskbar, Full-screen experience for Xbox gaming handhelds, Shared audio over Bluetooth LE in preview, and improvements to the WOA Prism emulator (which partially explains the expectations bit above) Microsoft Edge password manager can now save and sync passkeys, but you should still use a third-party password/identity manager Microsoft Store gets a bulk installer but only on the web Earnings learnings Microsoft earnings: Revenues up 18 percent to $77.7 billion but cost of AI is spiraling out of control and will only get bigger this FY Productivity and Business Processes revenues up 17 percent YOY to $33 billion Intelligent Cloud revenues of $30.9 billion, a gain of 28 percent YOY More Personal Computing delivered $13.8 billion in revenues, up 4 percent YOY. CapEx/AI infrastructure build-out costs are $34.9 billion (vs. $20 billion one year ago), plus a $4.1 billion loss attributed to OpenAI that was mentioned in a 10-Q (SEC) filing but not in its earnings reports Paul's analysis sticks mostly to Wall Street complicity in Microsoft's earnings non-transparency shenanigans. This is getting weird, given the amounts of money we're now talking about This isn't a first, but Spotify's earnings announcements includes a few BS sleights of hand too AMD: 36 percent revenue growth isn't enough for Wall Street Alphabet/Google: Up 16 percent to $102.3 billion, ads are 72.5 percent of revenues Amazon: Up 13 percent to $180 billion in revenues, $30 from AWS Apple: Up 8 percent to $102.5 billion, this quarter will be its best ever AI, antitrust, & dev Epic Games and Google announce settlement in Epic v. Google, a dramatic common-sense move that Apple should (but won't) emulate Regulatory filings tied to Microsoft earnings suggest OpenAI lost $12 billion in most recent quarter Freed from Microsoft, OpenAI immediately signs $38 billion infrastructure deal with AWS .NET 10 to launch next week at .NET Conf 2025 Xbox & games Xbox Game Pass getting Call of Duty Black Ops 7, five more Day One games in coming days (with an *) Xbox October Update rolls out with game shader preloading on Xbox Ally, new modules in Game Hubs on console, more games to stream on Xbox Cloud Gaming, more Nintendo Switch 2 is off to a blockbuster first year with T These show notes have been truncated due to length. For the full show notes, visit https://twit.tv/shows/windows-weekly/episodes/957 Hosts: Leo Laporte, Paul Thurrott, and Richard Campbell Sponsors: helixsleep.com/windows framer.com/design promo code WW 1password.com/windowsweekly auraframes.com/ink

We've heard that Microsoft will go off script this year with a 26H1 release of Windows 11 specifically aimed at Snapdragon X2-based PCs, as it did with the early release of 24H2 last year for the first-generation Snapdragon X. Also, Microsoft's latest earnings call left analysts baffled as execs dodged questions about multibillion-dollar AI losses and the real story behind OpenAI's ballooning deficit.26H1! Now confirmed by the release notes of a Windows Update And the Dev channel will soon switch over to 26H1 testing, with Beta moving to 25H2 (from 24H2) Expectations? All three versions will be functionally identical except for some Copilot+ PC-specific features that may be briefly only on Snapdragon X2. And then there will be a 26H2 for everyone More Windows 11 Microsoft (over) simplifies its Windows Update naming scheme, and then has to backtrack a bit because of admin/IT backlash October Preview Update screwed up Task Manager a little bit Dev/Beta update noted above included a new build with Ask Copilot in the Taskbar, Full-screen experience for Xbox gaming handhelds, Shared audio over Bluetooth LE in preview, and improvements to the WOA Prism emulator (which partially explains the expectations bit above) Microsoft Edge password manager can now save and sync passkeys, but you should still use a third-party password/identity manager Microsoft Store gets a bulk installer but only on the web Earnings learnings Microsoft earnings: Revenues up 18 percent to $77.7 billion but cost of AI is spiraling out of control and will only get bigger this FY Productivity and Business Processes revenues up 17 percent YOY to $33 billion Intelligent Cloud revenues of $30.9 billion, a gain of 28 percent YOY More Personal Computing delivered $13.8 billion in revenues, up 4 percent YOY. CapEx/AI infrastructure build-out costs are $34.9 billion (vs. $20 billion one year ago), plus a $4.1 billion loss attributed to OpenAI that was mentioned in a 10-Q (SEC) filing but not in its earnings reports Paul's analysis sticks mostly to Wall Street complicity in Microsoft's earnings non-transparency shenanigans. This is getting weird, given the amounts of money we're now talking about This isn't a first, but Spotify's earnings announcements includes a few BS sleights of hand too AMD: 36 percent revenue growth isn't enough for Wall Street Alphabet/Google: Up 16 percent to $102.3 billion, ads are 72.5 percent of revenues Amazon: Up 13 percent to $180 billion in revenues, $30 from AWS Apple: Up 8 percent to $102.5 billion, this quarter will be its best ever AI, antitrust, & dev Epic Games and Google announce settlement in Epic v. Google, a dramatic common-sense move that Apple should (but won't) emulate Regulatory filings tied to Microsoft earnings suggest OpenAI lost $12 billion in most recent quarter Freed from Microsoft, OpenAI immediately signs $38 billion infrastructure deal with AWS .NET 10 to launch next week at .NET Conf 2025 Xbox & games Xbox Game Pass getting Call of Duty Black Ops 7, five more Day One games in coming days (with an *) Xbox October Update rolls out with game shader preloading on Xbox Ally, new modules in Game Hubs on console, more games to stream on Xbox Cloud Gaming, more Nintendo Switch 2 is off to a blockbuster first year with T These show notes have been truncated due to length. For the full show notes, visit https://twit.tv/shows/windows-weekly/episodes/957 Hosts: Leo Laporte, Paul Thurrott, and Richard Campbell Sponsors: helixsleep.com/windows framer.com/design promo code WW 1password.com/windowsweekly auraframes.com/ink

We've heard that Microsoft will go off script this year with a 26H1 release of Windows 11 specifically aimed at Snapdragon X2-based PCs, as it did with the early release of 24H2 last year for the first-generation Snapdragon X. Also, Microsoft's latest earnings call left analysts baffled as execs dodged questions about multibillion-dollar AI losses and the real story behind OpenAI's ballooning deficit.26H1! Now confirmed by the release notes of a Windows Update And the Dev channel will soon switch over to 26H1 testing, with Beta moving to 25H2 (from 24H2) Expectations? All three versions will be functionally identical except for some Copilot+ PC-specific features that may be briefly only on Snapdragon X2. And then there will be a 26H2 for everyone More Windows 11 Microsoft (over) simplifies its Windows Update naming scheme, and then has to backtrack a bit because of admin/IT backlash October Preview Update screwed up Task Manager a little bit Dev/Beta update noted above included a new build with Ask Copilot in the Taskbar, Full-screen experience for Xbox gaming handhelds, Shared audio over Bluetooth LE in preview, and improvements to the WOA Prism emulator (which partially explains the expectations bit above) Microsoft Edge password manager can now save and sync passkeys, but you should still use a third-party password/identity manager Microsoft Store gets a bulk installer but only on the web Earnings learnings Microsoft earnings: Revenues up 18 percent to $77.7 billion but cost of AI is spiraling out of control and will only get bigger this FY Productivity and Business Processes revenues up 17 percent YOY to $33 billion Intelligent Cloud revenues of $30.9 billion, a gain of 28 percent YOY More Personal Computing delivered $13.8 billion in revenues, up 4 percent YOY. CapEx/AI infrastructure build-out costs are $34.9 billion (vs. $20 billion one year ago), plus a $4.1 billion loss attributed to OpenAI that was mentioned in a 10-Q (SEC) filing but not in its earnings reports Paul's analysis sticks mostly to Wall Street complicity in Microsoft's earnings non-transparency shenanigans. This is getting weird, given the amounts of money we're now talking about This isn't a first, but Spotify's earnings announcements includes a few BS sleights of hand too AMD: 36 percent revenue growth isn't enough for Wall Street Alphabet/Google: Up 16 percent to $102.3 billion, ads are 72.5 percent of revenues Amazon: Up 13 percent to $180 billion in revenues, $30 from AWS Apple: Up 8 percent to $102.5 billion, this quarter will be its best ever AI, antitrust, & dev Epic Games and Google announce settlement in Epic v. Google, a dramatic common-sense move that Apple should (but won't) emulate Regulatory filings tied to Microsoft earnings suggest OpenAI lost $12 billion in most recent quarter Freed from Microsoft, OpenAI immediately signs $38 billion infrastructure deal with AWS .NET 10 to launch next week at .NET Conf 2025 Xbox & games Xbox Game Pass getting Call of Duty Black Ops 7, five more Day One games in coming days (with an *) Xbox October Update rolls out with game shader preloading on Xbox Ally, new modules in Game Hubs on console, more games to stream on Xbox Cloud Gaming, more Nintendo Switch 2 is off to a blockbuster first year with T These show notes have been truncated due to length. For the full show notes, visit https://twit.tv/shows/windows-weekly/episodes/957 Hosts: Leo Laporte, Paul Thurrott, and Richard Campbell Sponsors: helixsleep.com/windows framer.com/design promo code WW 1password.com/windowsweekly auraframes.com/ink

The October Logistics Managers' Index data, detailed in the article October LMI shows price increases outpacing capacity growth, shows transportation utilization (57.3) and pricing (61.7) surged, reversing the prior negative freight inversion. This tight market prediction is worsened by the immediate air cargo capacity shock stemming from the UPS MD-11 crash on November 5th, a tragedy covered in LATEST: Death toll in UPS cargo jet crash rises to 7. This incident led to seven confirmed fatalities and resulted in the indefinite closure of the Louisville Muhammad Ali International Airport and the complete halt of UPS Worldport operations. Regulatory pressure is further squeezing the driver pool through the FMCSA's new non-domiciled CDL rule, which prevents Ukrainian war refugees from renewing legally obtained licenses, a complex issue explored in CDL overhaul tailspins Ukrainian truckers. Meanwhile, labor friction is mounting as the Teamsters union accuses UPS of violating its contract by diverting delivery work to non-union gig drivers at subsidiaries like Roadie and Happy Returns, a conflict covered in Teamsters union to press UPS over Roadie use of gig drivers. Shifting focus to corporate performance, Uber Freight revenue flat in Q3 as company posts strong delivery gains reports the freight unit's Q3 revenue remained flat at $1.31 billion and incurred a loss, even as Uber's overall mobility and delivery divisions saw strong growth and record adjusted EBITDA. Conversely, TFI CEO Alain Bedard anticipates a weak fourth quarter, yet offers a strongly positive long-term outlook, particularly for 2026, due to operational improvements in LTL and potential infrastructure impacts, as detailed in TFI's Bedard sees a stronger 2026 after a weak 4Q. Learn more about your ad choices. Visit megaphone.fm/adchoices

The recruiting technology landscape is transforming at an unprecedented speed. AI Tools that seemed like far-fetched concepts just a few years ago are hitting the market and delivering results. But adoption is messy and uneven. Some employers are experimenting with AI-driven interviews, while others worry about bias and legal risks. High-volume recruiters are automating entire processes while executive search remains deeply human. Everyone's trying to figure out which tools actually work and how to integrate them without breaking what already exists. So how should talent acquisition leaders navigate this revolution? My guest this week is Josh Bersin, one of the world's leading HR technology analysts. In our conversation, he reveals why this transformation is inevitable and what smart TA leaders should be doing today. In the interview, we discuss: Why TA is facing a reckoning Time, resources, and human error Where AI currently has the most impact Mass personalization Regulatory risks What role should human recruiters be playing? Superworkers AI Fluency versus amount of work experience The impact on an already bloated TA Tech Stack Technology mergers and acquisitions What does the future look like? Follow this podcast on Apple Podcasts.

We've heard that Microsoft will go off script this year with a 26H1 release of Windows 11 specifically aimed at Snapdragon X2-based PCs, as it did with the early release of 24H2 last year for the first-generation Snapdragon X. Also, Microsoft's latest earnings call left analysts baffled as execs dodged questions about multibillion-dollar AI losses and the real story behind OpenAI's ballooning deficit.26H1! Now confirmed by the release notes of a Windows Update And the Dev channel will soon switch over to 26H1 testing, with Beta moving to 25H2 (from 24H2) Expectations? All three versions will be functionally identical except for some Copilot+ PC-specific features that may be briefly only on Snapdragon X2. And then there will be a 26H2 for everyone More Windows 11 Microsoft (over) simplifies its Windows Update naming scheme, and then has to backtrack a bit because of admin/IT backlash October Preview Update screwed up Task Manager a little bit Dev/Beta update noted above included a new build with Ask Copilot in the Taskbar, Full-screen experience for Xbox gaming handhelds, Shared audio over Bluetooth LE in preview, and improvements to the WOA Prism emulator (which partially explains the expectations bit above) Microsoft Edge password manager can now save and sync passkeys, but you should still use a third-party password/identity manager Microsoft Store gets a bulk installer but only on the web Earnings learnings Microsoft earnings: Revenues up 18 percent to $77.7 billion but cost of AI is spiraling out of control and will only get bigger this FY Productivity and Business Processes revenues up 17 percent YOY to $33 billion Intelligent Cloud revenues of $30.9 billion, a gain of 28 percent YOY More Personal Computing delivered $13.8 billion in revenues, up 4 percent YOY. CapEx/AI infrastructure build-out costs are $34.9 billion (vs. $20 billion one year ago), plus a $4.1 billion loss attributed to OpenAI that was mentioned in a 10-Q (SEC) filing but not in its earnings reports Paul's analysis sticks mostly to Wall Street complicity in Microsoft's earnings non-transparency shenanigans. This is getting weird, given the amounts of money we're now talking about This isn't a first, but Spotify's earnings announcements includes a few BS sleights of hand too AMD: 36 percent revenue growth isn't enough for Wall Street Alphabet/Google: Up 16 percent to $102.3 billion, ads are 72.5 percent of revenues Amazon: Up 13 percent to $180 billion in revenues, $30 from AWS Apple: Up 8 percent to $102.5 billion, this quarter will be its best ever AI, antitrust, & dev Epic Games and Google announce settlement in Epic v. Google, a dramatic common-sense move that Apple should (but won't) emulate Regulatory filings tied to Microsoft earnings suggest OpenAI lost $12 billion in most recent quarter Freed from Microsoft, OpenAI immediately signs $38 billion infrastructure deal with AWS .NET 10 to launch next week at .NET Conf 2025 Xbox & games Xbox Game Pass getting Call of Duty Black Ops 7, five more Day One games in coming days (with an *) Xbox October Update rolls out with game shader preloading on Xbox Ally, new modules in Game Hubs on console, more games to stream on Xbox Cloud Gaming, more Nintendo Switch 2 is off to a blockbuster first year with T These show notes have been truncated due to length. For the full show notes, visit https://twit.tv/shows/windows-weekly/episodes/957 Hosts: Leo Laporte, Paul Thurrott, and Richard Campbell Sponsors: helixsleep.com/windows framer.com/design promo code WW 1password.com/windowsweekly auraframes.com/ink