Podcasts about regulatory

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.

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

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

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.

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.  

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

In 2026, governments across Asia grapple with escalating cybersecurity challenges amid rapid digital transformation and geopolitical tensions. AI-powered threats, including sophisticated phishing and deepfakes, pose significant risks, with IDC forecasting that 76.5% of Asia/Pacific enterprises lack confidence in detecting such attacks. Ransomware continues to evolve, targeting critical infrastructure, while supply chain vulnerabilities expose sensitive data—Gartner predicts 45% of global organisations will face software supply chain attacks by 2025, a trend persisting into 2026. Cloud adoption amplifies hybrid environment breaches, compounded by espionage-driven incursions, as Verizon reports 25% of APAC cyberattacks motivated by spying, with public administration the most targeted sector. Regulatory mandates demand robust compliance, straining resources in an era of legacy systems and talent shortages.In this PodChats for FutureCISO, Aaron Bugal, Field CISO, APJ, Sophos, walks us through some of the coming cybersecurity issues government CISOs as well as those in the private sector, will find important in 2026.1.       How can government CISOs effectively measure and improve their cybersecurity resilience, moving beyond compliance-based checklists to ensure the continuous delivery of essential citizen services during an attack?2.       What strategies, have proven, most effective for securing legacy systems that remain critical to national operations, given they cannot be immediately replaced?3.       With Gartner highlighting that by 2026, 50% of C-level executives will have performance requirements tied to cybersecurity risk, how can government CISOs best align their security metrics with national-level outcomes? 4.       How can CISOs proactively defend against state-aligned (sponsored) actors who are increasingly targeting digital public services and critical infrastructure for espionage and disruption?5.       Name one CISO strategy for managing third-party and supply chain risk, particularly as organisations, both private and public, rely on an ecosystem of partners to deliver complex, cloud-native government services?6.       Given IDC's prediction that by 2026, 70% of organisations will consider environmental sustainability in their cloud purchase decisions, how can CISOs balance security, sovereignty, and sustainability in their technology procurements?7.       How are government CISOs addressing the critical cybersecurity skills gap, and what new models for talent acquisition and retention must be developed to compete with the private sector? a.       How to avoid burnout?8.       To what extent have CISOs integrated security into the entire application lifecycle (DevSecOps) for their national digital identity and other citizen-facing platforms?9.       Name a governance and technical framework for the safe and ethical adoption of AI, both to enhance a government's cyber defences and to mitigate its potential malicious use by threat actors?10.   How are government CISOs collaborating with regional counterparts and international bodies to share threat intelligence and establish coordinated response protocols for cross-border cyber incidents?11.   What is that one final advice for government CISOs as their update their cybersecurity strategies for 2026?

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

During our conversation, Anthony Morreale, PharmD shares lessons from his remarkable 40-year career in pharmacy, including decades of leadership with the U.S. Department of Veterans Affairs. Dr. Morreale reflects on how curiosity, flexibility, and teamwork helped him identify and fill healthcare gaps, launch clinical pharmacy programs, and mentor future leaders. He discusses the growing importance of informatics, data-driven decision-making, and advanced therapeutics in shaping the future of pharmacy. Now a consultant and expert witness, Dr. Morreale continues to "fix gaps" by applying clinical insight to complex medical-legal cases. His story offers inspiration and practical wisdom for pharmacists at every career stage.   To learn more about Dr. Morreale, visit www.morrealeconsulting.com or connect on LinkedIn: https://www.linkedin.com/in/anthony-morreale-b8753635/    Special thanks to Dr. Pam Schweitzer for nominating Dr. Anthony Morreale as a guest.   Bio (October 2025) - Anthony P. Morreale, PharmD., MBA, BCPS, FASHP, CPEL   Dr. Morreale has demonstrated his professionalism and expertise as a clinician, manager and leader in pharmacy since his pharmacy career began in 1983. He has over 20 years of direct patient care experience as a clinical pharmacist in both acute and ambulatory care. In addition, he has decades of experience as a pharmacy manager, leader and executive. Dr. Morreale is board certified in pharmacotherapy and has been recognized by the American Society of Health System Pharmacists as a Certified Pharmacy Executive Leader. Dr. Morreale has been engaged as a business consultant, quality reviewer for standards of practice, and has served as an expert in medical legal cases. Dr. Morreale has expert knowledge and experience in nearly all areas of pharmacy practice including but not limited to:   •  Regulatory, operational and clinical pharmacy standards of practice for large health systems. •  Drug absorption, metabolism, excretion, outcomes, and adverse effects of both pharmaceuticals and street drugs. •  Application of patient genomics to therapeutic response and toxicities of various medications.   Dr. Morreale retired in October 2024 from his role as Associate Chief Consultant for Clinical Pharmacy Services and Policy for the Department of Veterans Affairs (VA) Pharmacy Benefits Management (PBM) in VA Central Office, where he oversaw national clinical pharmacy services, policy development, pay, recruitment, retention and legislation. He also has significant experience in Health Outcomes Research. Dr. Morreale is a highly experienced speaker both nationally and internationally and is very comfortable delivering understandable and succinct messages to various audiences. Dr. Morreale has authored or co-authored over 90 articles, has served on editorial boards, and as a reviewer on a number of professional journals.  He has been actively involved in leadership roles within many pharmacy organizations both nationally and internationally.   Dr. Morreale is the recipient of numerous awards including- ASHP Best Practice Award, ASHP Literature award for innovation, VA Under-Secretary's Innovation Award, JMCP Quality Reviewer Award for Accuracy, San Diego Society Pharmacist of the Year, California Michelotti Public Health Prize, the AMCP Avey Award, and most recently the APhA Distinguished Federal Pharmacist Award in 2018, and the ASHP Award for Excellence in 2020 and the ASHP Best Practice Award 2024.    Links from this episode Dr. Morreale's Website www.morrealeconsulting.com  Dr. Morreale on LinkedIn https://www.linkedin.com/in/anthony-morreale-b8753635/ U.S. Department of Veterans Affairs https://www.va.gov/ The Pharmacist's Voice Podcast Episode 185 featuring RDML Pam Schweitzer The Pharmacist's Voice Podcast Episode 229 featuring RDML Pam Schweitzer The Pharmacist's Voice Podcast Episode 251 featuring RDML Pam Schweitzer The Pharmacist's Voice Podcast Episode 133 featuring Dan Krinsky, RPh   Kim's websites and social media links: ✅ Monthly email newsletter sign-up link https://bit.ly/3AHJIaF  ✅ LinkedIn Newsletter link https://bit.ly/40VmV5B ✅ Audiobook Narration Services https://www.kimnewlove.com/narration  ✅ Business website https://www.thepharmacistsvoice.com ✅ Buy my book on amazon.com https://amzn.to/4iAKNBs  ✅ The Pharmacist's Voice ® Podcast https://www.thepharmacistsvoice.com/podcast ✅ Drug pronunciation course https://www.kimnewlove.com ✅ Podcasting Course https://www.kimnewlove.com/podcasting   ✅ LinkedIn https://www.linkedin.com/in/kimnewlove ✅ Facebook https://www.facebook.com/kim.newlove.96 ✅ Twitter https://twitter.com/KimNewloveVO ✅ Instagram https://www.instagram.com/kimnewlovevo/ ✅ YouTube https://www.youtube.com/channel/UCA3UyhNBi9CCqIMP8t1wRZQ ✅ ACX (Audiobook Narrator Profile) https://www.acx.com/narrator?p=A10FSORRTANJ4Z If you know someone who would like this episode, please share it with them. Subscribe for all future episodes. This podcast is on all major podcast players and YouTube. Popular links are below. ⬇️   Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   ⭐️ Sign up for The Pharmacist's Voice ® monthly email newsletter! https://bit.ly/3AHJIaF   Host Background: Kim Newlove has been an Ohio pharmacist since 2001 (BS Pharm, Chem Minor). Her experience includes hospital, retail, compounding, and behavioral health. She is also an author, voice actor (medical narrator and audiobook narrator), podcast host, and consultant (audio production and podcasting).   Thank you for listening to episode 355 of The Pharmacist's Voice ® Podcast.  If you know someone who would like this episode, please share it with them!

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

As we plan for 2026, many CX, UX, and Market Research teams are focused on anticipating project volume, evolving method mixes, AI-enabled workflows, and resource allocation. But regulatory policy deserves attention too—with changes coming that could directly shape how we run qualitative and quantitative projects.  In this episode of Conversations for Research Rockstars, Kathryn Korostoff interviewed Howard Fienberg, Senior VP Advocacy at the Insights Association, about two regulatory shifts that could impact researchers. Kathryn and Howard also discuss how these regulations could create meaningful cost savings and workflow improvements for researchers in both qual and quant settings. Conversations for Research Rockstars is produced by Research Rockstar Training & Staffing. Our 25+ Market Research eLearning classes are offered on demand and include options to earn Insights Association Certificates. Our Rent-a-Researcher staffing service places qualified, fully vetted market research experts, covering temporary needs due to project and resource fluctuations. We believe it: Inside every market researcher is a Research Rockstar! Hope you enjoy this episode of Conversations for Research Rockstars. http://www.researchrockstar.com/ Facebook | LinkedIn | 877-Rocks10 ext 703 for Support, 701 for Sales Info@ResearchRockstar.com 

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of groundbreaking advancements and strategic collaborations that promise to transform drug development and patient care.In the autoimmune space, Boehringer Ingelheim has made a significant move by securing a $570 million agreement with CDR-Life. This deal centers on a trispecific antibody, a novel therapeutic approach that targets multiple pathways simultaneously, potentially revolutionizing treatments for autoimmune diseases. Boehringer's commitment to these cutting-edge modalities highlights their strategy to leverage novel technologies for more effective therapeutic solutions.Similarly, Celltrion has entered a $744 million collaboration with Kaigene, focusing on two preclinical autoimmune drugs. This partnership marks Celltrion's strategic shift from biosimilars to novel biologics, positioning the company at the forefront of biologic therapeutics. By investing in early-stage research, Celltrion aims to introduce transformative therapies for autoimmune conditions, showcasing the industry's willingness to bet on groundbreaking scientific advancements.In gene editing, Azalea Therapeutics is gaining attention with its focus on permanent genome editing using a dual-vector approach. Backed by $82 million in funding and support from CRISPR pioneer Jennifer Doudna, Azalea is poised to develop potentially curative solutions through single-dose treatments. The credibility lent by a Nobel laureate adds anticipation to their research outcomes, with the potential to significantly impact gene therapy.Shifting focus to clinical trials, Sarepta Therapeutics faces challenges after missing the primary endpoint in its confirmatory trial for Duchenne muscular dystrophy drugs. Despite this setback, Sarepta is pursuing full FDA approval, emphasizing the complex interplay between clinical data and regulatory strategies. This situation underscores the critical importance of robust confirmatory trials in securing drug approvals and ensuring patient access to new therapies.Merck is making strategic moves in oncology by regaining full control over an early-phase asset and securing $700 million from Blackstone for its oncology pipeline. This dual focus on asset acquisition and financial fortification reflects Merck's aggressive growth strategy aimed at expanding its cancer treatment offerings.Emerging from stealth mode, Neok Bio has secured a $75 million investment to advance bispecific antibody-drug conjugates into clinical trials. These bispecific ADCs represent the forefront of targeted cancer therapies, aiming for precision targeting of cancer cells while minimizing off-target effects. Neok Bio's progress could significantly enhance oncology treatment paradigms through improved therapeutic indices.Turning to regulatory landscapes, Teva's recall of over half-a-million bottles of prazosin hydrochloride due to potential carcinogenic impurities highlights ongoing challenges in ensuring drug safety and quality control within manufacturing processes. Such recalls underscore the critical importance of maintaining high standards in pharmaceutical production.In broader industry developments, we see dynamic trends where scientific innovation meets strategic business decisions and regulatory considerations. The potential impact on patient care is profound, with breakthroughs in autoimmune treatments, gene editing technologies, and targeted cancer therapies poised to alter therapeutic landscapes significantly.UCB has achieved another milestone with FDA approval for Kygevvi, an ultra-rare disease medication marking their third approval in rare conditions within three years. This success underscores UCB's strategic focus on niche markets that offer less competition but significant patient impact. Advancements in genetic research aSupport the show

Join speakers from IQVIA Digital and IQVIA Applied AI Science as they discuss DTC marketing and governance as we head into 2026. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register!    AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket!    Check us out at: mmm-online.com   Follow us:  YouTube: @MMM-online TikTok: @MMMnews Instagram: @MMMnewsonline Twitter/X: @MMMnews LinkedIn: MM+M   To read more of the most timely, balanced and original reporting in medical marketing, subscribe here. Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com for information about our collection and use of personal data for advertising.

For episode 620 of the BlockHash Podcast, host Brandon Zemp is joined by Rens Troost, Founder & CTO of Rational Exponent.Their flagship platform, RE:Agent, empowers customers to adapt quickly to evolving regulatory requirements with actionable intelligence, dynamic controls, and strategic risk insights embedded directly into operational workflows. Purpose-built for scalability, transparency, and agility, Rational Exponent makes it possible for organizations to maximize operational performance and accelerate growth while remaining grounded in prudent, compliant risk management.  Rens brings 30+ years of leadership experience, from early-stage startups to NASDAQ-listed companies. He's a repeat founder, board member, and CTO for Rational Exponent, an AI-native fintech company coming out of Stealth to start the movement for building banks of the future. ⏳ Timestamps: (0:00) Introduction(0:57) Who is Rens Troost?(3:21) What is RE:Agent?(6:36) RE:Agent use-cases(10:42) Impact of AGI(14:38) Guardrails for AGI(20:14) Goals at Money20/20(23:05) Contact Rational Exponent 

For-hire trucking capacity is contracting significantly due to a 32% reduction in tractor builds (taking equipment below replacement levels) and stricter FMCSA English Language Proficiency enforcement, which could affect up to 10% of the driver pool. Despite shrinking capacity, freight rates are only seeing marginal spot market improvements of 1-2%, failing to keep pace with 3% inflation, due to volume volatility and broader macroeconomic risks. Regulatory friction is also widespread, as a federal judge issued a preliminary injunction blocking the California Air Resources Board from enforcing its Clean Truck Partnership against major OEMs (like Daimler, PACCAR, and Volvo). This legal development was driven by the judge's conclusion that CARB's lawsuit was attempting to enforce potentially federally preempted standards, creating an "impossible situation" for manufacturers after federal waivers for rules like the Advanced Clean Truck rule were withdrawn. In stark contrast to regulatory tangles, technology offers surprisingly frictionless solutions: fleets using complete AI safety solutions saw a 73% reduction in crash rates over 30 months, nearly double the industry average. Within just six months of implementation, these systems also achieved a 49% drop in harsh driving events and an 84% reduction in mobile phone use behind the wheel, alongside a 57% boost in Hours of Service compliance. Serious, hyperfocused investment is flowing into specialized logistics globally, notably in air cargo where Cargojet launched a new direct weekly service connecting its Canadian hubs to Liege Airport in Belgium. Latam Cargo also boosted its Europe-South America capacity by 25% (reaching 15 weekly frequencies), adding specialized routes like São Paulo to Brussels with a stop in Recife to handle mango exports. Domestically, TRAC Intermodal is focusing on standardization and efficiency by partnering with Florida East Coast Railway to stage standardized, GPS-integrated 53-ft domestic chassis directly at FEC terminals, aiming to build a national footprint for their T-53 program. Meanwhile, UPS completed its $1.6 billion acquisition of Andlauer Healthcare Group to strengthen its specialized Canadian cold chain and accelerate its strategic goal of doubling high-margin healthcare logistics revenue to $20 billion by 2026. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode, Sierra Nicholson is joined by Eversheds Sutherland partners Tim Fosh and Michael Koffler to discuss how technology is transforming financial regulation, the importance of smart regulation, and the growing impact of private and digital assets on markets and investors.

Laurent and Gerard have an explosive conversation with Bryan Long, Executive Director in JPMorgan's Commodities Group.They explore why U.S. energy market signals are failing to support new capacity investments, despite soaring demand (especially from datacenters).  Key issues include misaligned pricing, liquidity constraints, and hedging challenges, all of which deter long-term private capital.Key Takeaways: Current price signals don't support investment in new generation, even as large load growth (e.g., datacenters) is accelerating. Market structures must evolve to better reflect long-term price signals and attract private capital. Supply-side issues: New natural gas peakers and battery storage (BESS) face fragmented development, rising CAPEX, procurement delays, and tariff risks. Industry response: Major consolidation in the IPP space—private equity-backed assets are being acquired by integrated players seeking scale for hyperscaler deals.Possible solutions may include Repricing of forward curves, Government-backed long-term contracts, Regulatory reforms, Technological advancements Bottom line: Something must shift—be it policy, pricing, or tech—to align investment incentives with future demand growth. The next several years should be great for traders in the middle of the action.Conclusion: Between the Large Load Growth and the Investment Capital, who will blink first?   ------------  Bryan Long is an Executive Director in JPMorgan's Commodities Group, focused on wholesale power & renewable energy transactions. With 20yrs+ experience across various U.S. Power trading, origination and management roles, he has deep understandings of electricity market structures.    

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.We cover practical implications of recent and emerging regulations, including:Batteries Regulation (EU) 2023/1542AI Act (EU) 2024/1689Packaging and Packaging Waste Regulation (EU) 2025/40European Health Data Space Regulation (EU) 2025/327You'll learn:About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.How to identify all applicable legislation for your product and verify coverage.What notified bodies expect to see and the typical level of scrutiny.How to structure your compliance register, QMS updates, and regulatory reporting.Transition timelines and planning tactics to avoid last-minute surprises.Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.Panelists and moderator:Greg Griffin, PhD, MRSE – Technical Specialist, BSIClaire Burrows – Regulatory Partner, BrabnersChris Parr, PMP – Principal, RQM+Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)--

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠RQMplus.com⁠⁠.PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, RQM+ leaders from regulatory, clinical, and scientific writing share what MDR reviewers look for and how to design surveys that generate decision-grade evidence. The session is intended for regulatory affairs, post-market surveillance, clinical evidence, and medical writing leaders at MedTech manufacturers.Listen to learn how to: Define clear objectives, endpoints, and target population so the survey maps to your PMCF plan and CER. Improve response rates without bias and capture higher-quality data, including adverse events and usability feedback. Learn how to position your physician level survey as a chart review. Document methods, rationales, and traceability so notified bodies can follow the logic. Avoid the top reasons reviewers push back on PMCF surveys and how to correct them. Walk away with a practical checklist to pressure test your next PMCF survey and reduce review risk. Who should attend: Regulatory affairs leaders and PMS managers. Clinical evidence and clinical operations leads. Scientific and medical writing leaders, including CER and PSUR authors. Quality leaders responsible for post market surveillance programs. Panelists and moderator: Torrie DeGennaro – Vice President, Scientific & Medical Writing Bethany Chung, Ph.D., RAC – Director, Technical Solutions & Innovation Garrett Jeffries, Ph.D. – Principal Jon Gimbel, Ph.D. – Vice President, Regulatory Affairs--

In this episode of The Edge of Risk podcast by IRMI, host Joel Appelbaum speaks with Jim DeVoe-Talluto, assistant director of captive insurance at the Vermont Department of Financial Regulation, about what organizations need to know when applying to form a captive insurance company. Drawing on more than 2 decades of regulatory experience, Mr. DeVoe-Talluto outlines the steps applicants should expect, the most common barriers to approval, and the importance of a strong feasibility study and experienced advisers. Mr. DeVoe-Talluto also discusses Vermont's regulatory philosophy and why early planning, clarity of purpose, and strong executive buy-in significantly improve the chance of success. Whether you're exploring a first-time captive or seeking insight into regulator expectations in one of the world's largest captive domiciles, this conversation delivers timely, practical guidance directly from the source.

We'd love to hear from you. What are your thoughts and questions?In this enlightening conversation, Attorney Blake Harris discusses the intricacies of offshore trusts and their advantages over domestic trusts. He shares his journey into the world of international asset protection, emphasizing the importance of understanding the differences between offshore and domestic trusts. Harris addresses common misconceptions about offshore trusts, highlighting their legitimacy and the regulatory frameworks that govern them. He also outlines who should consider setting up an offshore trust and the benefits of doing so, particularly for individuals with significant assets. The discussion further delves into the complexities involved in managing offshore trusts, including reporting requirements and the importance of choosing the right jurisdiction, with a focus on the Cook Islands as a preferred location for asset protection. Harris concludes by addressing the ethical considerations surrounding asset protection planning, advocating for proactive measures to secure one's financial future.Main Points:Offshore trusts provide greater asset protection than domestic trusts.The Cook Islands is a leading jurisdiction for offshore trusts.Understanding the complexities of offshore trusts is crucial for effective asset protection.Clients should consider offshore trusts if they have significant assets to protect.The cost of setting up an offshore trust can be justified by the long-term benefits.Networking and relationships are vital in the offshore trust industry.Regulatory frameworks in offshore jurisdictions can be more robust than in the U.S.Ethics in asset protection planning emphasize the importance of being proactive.Reporting requirements for offshore trusts are manageable with proper guidance.Education and awareness are key to dispelling myths about offshore trusts.Main Points:https://www.linkedin.com/in/blake-harris-08a106b/Tiktok & instagram-@blakeharrislawblake@blakeharrislaw.comhttps://blakeharrislaw.com/

Have you thought about investing into space? Mark Boggett, CEO of Seraphim, shares the investment opportunities in the rapidly expanding space industry. He explains how innovations led by SpaceX dramatically lowered launch costs and increased access to space, catalyzing growth in satellite constellations and data-driven applications for defense, climate, and communications. He emphasizes that near-term investment potential lies in defense and climate-related uses of satellite data, rather than speculative ventures like space travel or asteroid mining. He also highlights the growing importance of sustainability, debris management, and more. We discuss... Mark Boggett is a career technology investor who founded Seraphim Space, the world's first space-focused investment fund. Seraphim Space operates a global accelerator, a private venture fund, and a publicly listed growth fund on the London Stock Exchange. Boggett shifted focus to space investing after recognizing how technologies like AI, telecommunications, and 3D printing were transforming the sector. SpaceX revolutionized space access by reducing launch costs from $86,000 to $1,000 per kilogram and dramatically increasing launch frequency. Smaller, cheaper satellites now enable massive constellations that provide real-time Earth observation and global connectivity. Investment opportunities in space fall into three categories: upstream (launch and satellites), downstream (data and applications), and in-space (future lunar and interplanetary activities). The most investable areas today are defense and climate-related satellite data applications rather than speculative space travel or mining. The falling cost of launch is paving the way for large-scale space infrastructure, including future data centers powered by solar energy. Space debris is an emerging challenge, driving new industries focused on monitoring, avoiding, and removing defunct satellites. Regulatory changes now require satellite operators to deorbit defunct satellites within five years, accelerating growth in orbital cleanup services. Defense is a major driver of demand for satellite technology in intelligence, communications, navigation, and asset protection. The "in-space" category includes lunar landers, space stations, and eventual habitation or mining ventures, though these remain long-term prospects. NASA's new funding model relies on private companies like Axiom Space and Voyager to build commercial space stations. Boggett concludes that while long-term prospects like lunar mining are exciting, the current trillion-dollar opportunity lies in satellites, data, and communication serving Earth-based customers. Today's Panelists: Kirk Chisholm | Innovative Wealth Phil Weiss | Apprise Wealth Management Douglas Heagren | Mergent College Advisors Follow on Facebook: https://www.facebook.com/moneytreepodcast Follow LinkedIn: https://www.linkedin.com/showcase/money-tree-investing-podcast Follow on Twitter/X: https://x.com/MTIPodcast For more information, visit the show notes at https://moneytreepodcast.com/investing-into-space-mark-boggett-760

In this episode of The Brainstorm, join Nick Grous, Tasha Keeney, and Brett Winton as they dive into Tesla's latest earnings, the future of Robotaxis, and the challenges of humanoid robots. Explore insights on Tesla's production ramp, AI advancements, and the potential for full autonomy.If you know ARK, then you probably know about our long-term research projections, like estimating where we will be 5-10 years from now! But just because we are long-term investors, doesn't mean we don't have strong views and opinions on breaking news. In fact, we discuss and debate this every day. So now we're sharing some of these internal discussions with you in our new video series, “The Brainstorm”, a co-production from ARK and Public.com. Tune in every week as we react to the latest in innovation. Here and there we'll be joined by special guests, but ultimately this is our chance to join the conversation and share ARK's quick takes on what's going on in tech today.Key Points From This Episode:Tesla's recent earnings call highlighted increased confidence in their Robotaxi service and plans to scale production rapidly.Elon Musk expressed optimism about achieving unsupervised full self-driving capabilities soon, aiming for 3 million vehicles annually within two years.The discussion explored the complexity of humanoid robots, estimating the problem to be 200,000 times more challenging than Robotaxis.Tesla's strategy involves leveraging AI compute power and Robotaxi cash flow to advance humanoid robot development.Regulatory hurdles remain a significant factor in the rollout of full autonomy and Robotaxi services across different states.For more updates on Public.com:Website: https://public.com/YouTube: @publicinvestX: https://twitter.com/public

Geetha Panchapakesan, the founder and CEO of Tesser, joins the show. In this episode: Geetha's background in payments and how she arrived in stablecoins Major shifts across payments over Geetha's career Building a one-stop shop solution for financial institutions, PSPs and MSBs Where FIs are today as it relates to engaging to stablecoins Regulatory tailwinds post-GENIUS See more at tesser.xyz