Podcasts about compass pathways

In this episode of Denatured, you'll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsHans Eriksson, Chief Medical Officer, FundaMental PharmaSteve Levine, Chief Patient Officer, Compass PathwaysDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Psychedelic Therapy for Mental Health: Research, Safety, and the Path to FDA Approval: Dr. Will Van Derveer and Keith Kurlander, co-authors of “Psychedelic Therapy: A Revolutionary Approach to Restoring Your Mental Health and Reclaiming Your Life,” reveal the shift from recreational psychedelics to structured, research-based psychedelic-assisted therapy for conditions like PTSD, depression, and anxiety. Van Derveer describes limitations of conventional psychiatry (citing STAR*D remission rates) and his entry into MDMA-assisted PTSD research after promising results. They contrast controlled clinical protocols—screening, preparation, safe setting, trained facilitation, medical monitoring, and post-session integration—with uncontained recreational use. The discussion covers current policy momentum under Trump and RFK Jr., VA interest for veterans, and key agents: ketamine (including abuse risks and clinic-only Spravato), MDMA (phase 3 but not approved in 2024), psilocybin (phase 3, potential FDA approval), LSD (GAD trials), ibogaine (arrhythmia risk, Mexico clinics), ayahuasca, peyote, and microdosing. They also note commercialization, including Eli Lilly's acquisition of a 5-MeO-DMT nasal spray developer, and emphasize an integrative “all-of-the-above” mental health approach.

In der heutigen Folge sprechen die Finanzjournalisten Nando Sommerfeldt und Holger Zschäpitz über Ernüchterung bei Netflix, den finalen Atai-Moment und einen erwachenden Markt. Außerdem geht es um SpaceX, Alphabet, Oracle, Abbott Laboratories, UnitedHealth Group, J.B. Hunt Transport Services, AtaiBeckley, Eli Lilly, Compass Pathways, Definium Therapeutics, Infineon, ABB, Schneider Electric, Siemens Energy, ASML, Delivery Hero, Uber, Novo Nordisk, Burberry, Saab, Travelers, Yara, BlackRock, Goldman Sachs, JPMorgan Chase, Robinhood Markets, Reddit, Nvidia, Micron Technology, SanDisk, Applied Materials, Western Digital, KLA, Marvell Technology, Lam Research, iShares Nikkei 225 (WKN: A0YEDQ), Xtrackers MSCI Japan (WKN: DBX1MJ), Amundi Japan Topix (WKN: A2H58U), VanEck Space Innovators ETF (WKN: A3DP9J), Direxion Daily Semiconductor Bull 3X Shares / SOXL (WKN: A1C1G7) Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Hier könnt ihr den AAA-Newsletter abonnieren: https://www.welt.de/newsletter/article232797673/Alles-auf-Aktien-Der-taegliche-Boersen-Newsletter-fuer-WELTplus-Abonnenten.html Und – ganz neu: AAA gibt es jetzt auch auf Instagram: https://www.instagram.com/alles_auf_aktien/ Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien *Anzeige: Eight Sleep: Der Pod 5 reguliert die Temperatur im Bett automatisch, trackt Schlaf- und Gesundheitswerte ohne Wearable und kann so zu besserem Schlaf beitragen. Mit dem Code ALLESAUFAKTIEN erhaltet ihr auf https://www.eightsleep.com/allesaufaktien bis zu 350 Euro Rabatt.* Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Biogen's new data, presented at the Alzheimer's Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis' antisense therapeutic.

Good 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 significant advancements and challenges shaping the landscape of these dynamic sectors. Starting with Ipsen's Dysport, which has made notable strides in its Phase 3 trials for migraine prevention. The trials covered both episodic and chronic conditions, marking a first in the neurotoxin market. Dysport's success positions it as a formidable competitor to AbbVie's Botox, expanding therapeutic options for individuals battling migraine disorders. This achievement showcases the potential efficacy of botulinum toxin-based therapies in neurology and pain management, offering promising new avenues for patient care. In regulatory news, Boehringer Ingelheim has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for Jascayd, a small molecule PDE4B inhibitor with antifibrotic properties. This approval marks a significant milestone in the treatment of idiopathic and progressive pulmonary fibrosis. Jascayd's addition to the therapeutic arsenal offers new hope for managing this debilitating condition, emphasizing the ongoing efforts to improve patient outcomes through innovative treatments. The arena of business development sees HanChorBio partnering with InxMed to advance oncology research. By combining HCB101 with FAK inhibitors and FAP-targeted ADCs, this collaboration aims to leverage antibody and small molecule drug discovery techniques. The goal is to develop innovative cancer treatments that could redefine therapeutic approaches in oncology. Keenova Therapeutics has also reported success with Xiaflex for plantar fibromatosis. This enzyme injection therapy offers a novel approach by targeting collagen, thus providing an innovative solution for musculoskeletal conditions. Similarly, Fate Therapeutics' FT819, an off-the-shelf CAR-T therapy, has shown early promise in tackling treatment-resistant systemic sclerosis, underscoring the potential of cell therapies beyond oncology. Meanwhile, MindRank's successful Series B funding round of $52 million highlights the growing role of AI platforms in drug discovery. The funding will propel its AI-discovered oral GLP-1 obesity pill into Phase III trials, exemplifying how technology-driven solutions are gaining traction in addressing metabolic diseases like obesity. On the regulatory front, Saol Therapeutics has resubmitted SL1009 (DCA) to the FDA for pyruvate dehydrogenase complex deficiency. This submission underscores ongoing efforts to address rare metabolic disorders using small molecule therapies. Additionally, Sanofi's concessions to the EU regarding flu vaccine marketing illustrate the complexities of competitive dynamics and regulatory scrutiny within the vaccine market. However, not all developments are favorable. AstraZeneca and Ionis Pharmaceuticals faced a setback as their drug Wainua failed its Phase 3 trial for transthyretin-mediated amyloid cardiomyopathy. This outcome highlights the challenges inherent in developing effective treatments for complex cardiovascular conditions. Meanwhile, regulatory processes remain contentious as the FDA pauses its release of complete response letters amid debates over proprietary information disclosures. In another noteworthy development, GSK has terminated its $2.2 billion collaboration with Alector after underwhelming results from Alzheimer's drug trials. This decision highlights both financial implications and strategic shifts as companies reassess risk tolerance in neurodegenerative disease research. Conversely, Roche's success with its KRAS G12C inhibitor divarasib in Phase 3 lung cancer trials underscores the promise of precision medicine. Divarasib outperformed competitors Amgen's Lumakras and Bristol Myers Squibb's Krazati, positioning Roche to potentially redefine standards of care based on genetic profiles. In a move reflecting industry trends towards collaboration and innovation risk-sharing models, AstraZeneca has partnered with Sino Biopharmaceutical on respiratory disease research. This strategic alliance represents a substantial investment aimed at expanding AstraZeneca's pipeline in respiratory therapeutics. Lastly, amidst these developments, psychedelic drugs are experiencing a renaissance in psychiatric care. Companies like Compass Pathways are pioneering clinical validation for their use in treating depression, signaling a potential paradigm shift from traditional SSRIs to newer therapeutic classes pending safety and efficacy data. Overall, these stories illustrate a dynamic interplay of scientific progress and regulatory navigation within the pharmaceutical and biotech sectors. While challenges persist—particularly in neurodegenerative disease treatment—the breakthroughs in oncology and metabolic disorder therapeutics offer hopeful prospects for improving patient care. As these industries continue evolving, integrating advanced technologies such as AI will likely play a pivotal role in shaping future therapeutic landscapes.Support the show

Good 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 compelling stories that showcase the dynamic nature of this industry. In a landmark development, Vertex Pharmaceuticals has made headlines with its acquisition of Crinetics Pharmaceuticals for a staggering $10 billion. This move marks Vertex's strategic expansion into the endocrine disease sector, a significant shift from its traditional focus on cystic fibrosis. Crinetics' innovative approach to treating rare endocrine disorders will allow Vertex to address unmet needs in this area, highlighting a broader industry trend where mergers and acquisitions serve as key strategies for adapting to the evolving scientific landscape and patient demands. While Vertex makes bold moves, Kalohexis is preparing for a confidential initial public offering (IPO), focusing on treatments based on the melanocortin system for obesity and cancer cachexia. The melanocortin system is crucial in regulating energy homeostasis and inflammation, making it a promising target for therapeutic interventions. This development underscores the growing interest in peptide-based therapies and innovative scientific approaches to address complex metabolic disorders, further emphasizing the industry's shift towards tackling significant health challenges such as obesity. Clinical trials continue to be at the forefront of medical advancements. Compass Pathways has reported promising Phase III trial results for COMP360, its psilocybin-based therapy for treatment-resistant depression. These findings indicate a potential breakthrough in psychedelic therapy, offering new hope for patients who haven't benefited from existing antidepressant treatments. The exploration of psychedelics in mental health treatment represents a paradigm shift that could introduce novel therapeutic options and significantly impact patient care. Turning to regulatory news, AbbVie's Tepkinly (epcoritamab) has received European Commission approval for treating relapsed or refractory follicular lymphoma. This approval is based on robust Phase III data, underscoring the potential of bispecific antibodies as effective cancer therapies. Similarly, PharmaEssentia's Besremi (ropeginterferon alfa-2b) has obtained Health Canada approval for polycythemia vera treatment, highlighting the continued relevance of protein and interferon therapies in managing myeloproliferative neoplasms. In business development news, Novo Nordisk and Vivani Medical have partnered to develop an ultra-long-acting semaglutide implant for chronic weight management. This collaboration showcases advancements in drug delivery systems aimed at improving patient compliance and therapeutic outcomes. Meanwhile, Boehringer Ingelheim's licensing agreement with Prime Vector Technologies involves harnessing viral vectors for cancer vaccine development, emphasizing ongoing efforts to innovate within oncology. Despite these advancements, challenges persist within the industry. Notably, Bristol Myers Squibb's Krazati (adagrasib) failed its Phase III confirmatory trial in metastatic colorectal cancer with KRAS G12C mutations. This outcome highlights the complexities involved in developing targeted cancer therapies and underscores the need for continued innovation and exploration of combination treatments. The financial landscape also reflects strategic adjustments with Regeneron Pharmaceuticals reporting a $127 million charge impacting its earnings due to an in-process research and development expense. Additionally, Novartis is undergoing organizational restructuring with workforce reductions aimed at cost management within large pharmaceutical enterprises. On another front, China's recent approval of the world's first CAR-T therapy for solid tumors marks a significant leap forward from its traditional success in hematological malignancies. This development highlights the potential for CAR-T therapies to address complex challenges posed by solid tumors and could have profound implications for global cancer treatment paradigms. AstraZeneca's partnership with CSPC Pharmaceutical represents another strategic collaboration aimed at co-developing kidney disease drugs, reflecting Western pharmaceutical companies' efforts to leverage Chinese biotechnological capabilities. As companies navigate these complexities through strategic acquisitions, partnerships, and groundbreaking research, their ability to adapt will be crucial in shaping future patient care and therapeutic landscapes. The pharmaceutical and biotech industries remain at the forefront of scientific advancement, continually seeking solutions to complex medical needs while adapting to an ever-evolving global landscape.Support the show

Welcome to a special edition of IDEA Collider's "Deep Medicine" series. In this episode, host Alex Gray sits down with Athina Metaxa, a consultant at IDEA Pharma and psychedelic research expert, to discuss the rapidly shifting landscape of psychedelic medicine. With substantial unmet needs in treatment-resistant depression (TRD) and PTSD, the field is at a critical inflection point marked by new FDA prioritizations and breakthrough clinical data.  Athina shares insights from her meta-analysis on psilocybin and discusses the unique methodological challenges facing the industry, such as blinding integrity and the influence of expectancy effects in clinical trials. We explore the debate over whether the "psychedelic experience" is necessary for therapeutic benefit and how biotechs are balancing regulatory-friendly trial designs with patient safety.  Finally, Athina looks toward the future of precision psychiatry, examining the role of biomarkers and the immense logistical challenges of scaling these intensive therapies within global healthcare systems. Don't forget to Like, Share, Subscribe, Rate, and Review!     Keep up with Athina Metaxa; LinkedIn:  https://www.linkedin.com/in/athina-marina-metaxa/     Follow IDEA Pharma On; Website:  https://www.ideapharma.com/     Listen to more fantastic podcast episodes:  https://ideacollider.simplecast.com/

In this episode, Surani explores one of biotech's most controversial and ambitious frontiers: psychedelic medicine. At the center of the story is Compass Pathways, the London-based biotech attempting to bring synthetic psilocybin through the modern drug approval system for treatment-resistant depression. What began as a deeply personal mission for founders George and Katya Goldsmith has evolved into one of the most closely watched companies in mental health biotech, surviving both the psychedelic hype cycle and the broader biotech market crash. Surani speaks with CEO Kabir Nath to explore Compass's unusual financing journey, the rise of institutional interest from investors like Otsuka Pharmaceutical, and the company's pivotal Phase II and Phase III studies that may ultimately lead to the first FDA-approved psychedelic medicine. She is also joined by renowned neuropsychopharmacologist Professor David Nutt from Imperial College London to unpack the science, investor skepticism, regulatory concerns and implementation complexities surrounding psychedelics. Timestamps 00:01 — Introduction 02.00 — The Compass origin story: George and Katya Goldsmith, psilocybin, and building a biotech 07:00 — Early financing struggles, Peter Thiel, and why traditional biotech investors stayed away 08:30 — Otsuka, and the moment psychedelics entered the mainstream 11:00 — Compass IPOs into the biotech boom — then the market crashes 13:00 — The controversial Phase IIb results: remission rates, safety concerns, and investor backlash 21:00 — Kabir Nath joins Compass as CEO to launch the Phase III program 22:00 — Breaking down the Phase III data, durability questions, and FDA approval odds 26:00 — Lykos' FDA fiasco, psychotherapy, blinding debates, and the regulatory challenge for psychedelics 31:00 — Real-world rollout: J&Js Spravato, scalability, pricing, reimbursement, and Compass's future vision Founders' Story: Business Insider Article After On podcast: For any comments, questions or feedback you can connect directly with Surani Fernando on LinkedIn or email: raisingbiotech@gmail.com Title music composed by: Yrii Semchyshyn (Coma Media)

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a fascinating array of industry shifts and scientific breakthroughs that are shaping the future of medicine and patient care. Sun Pharma's acquisition of Organon for $11.75 billion is making waves as it marks a significant expansion for the Indian pharmaceutical giant into international markets. This deal not only amplifies Sun Pharma's footprint but also integrates Organon's strong focus on women's health and biosimilars into its portfolio. It's a strategic move that underscores the increasing trend of cross-border mergers as companies seek to diversify and enhance their global presence. As the largest-ever overseas acquisition by an Indian firm, this transaction is emblematic of the growing importance of global consolidation in the pharma industry. Meanwhile, Astellas Pharma faces a mixed fiscal outlook with its prostate cancer drug Xtandi. While Xtandi experienced a modest sales increase in 2025, a projected decline for 2026 has prompted Astellas to pivot towards developing new medicines. This highlights the critical dependence on innovation within the industry to sustain growth, especially as competition intensifies. In the realm of ATTR amyloidosis treatments, Pfizer has reached a settlement with two generic manufacturers over its drug Vyndamax. This resolution is crucial in stabilizing the market amidst rising generic competition, which can significantly influence pricing and market dynamics. Such settlements are an integral part of maintaining competitive positioning in crowded therapeutic spaces. Ligand Pharmaceuticals' strategic purchase of XOMA for $739 million signals a broader trend of consolidation among biotech royalty aggregators. This acquisition aligns with Ligand's strategy to augment its portfolio through mergers and acquisitions—a recurring theme as biotech companies strive to streamline operations and expand their competitive edge. The competition within the oral GLP-1 market is intensifying, particularly with Eli Lilly's delayed launch of Foundayo inadvertently benefiting Novo Nordisk's market position. This rivalry underscores the fierce race to dominate the lucrative obesity management sector, highlighting how pivotal timing can be in gaining market share. The FDA's recent allocation of national priority vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics marks a significant regulatory shift towards embracing psychedelic therapies. These vouchers could expedite development timelines, thereby accelerating patient access to novel treatments that have traditionally been underexplored. Thermo Fisher Scientific's robust start to 2026 showcases how strategic acquisitions like that of Clario can drive growth. This reflects broader industry trends where biopharma companies leverage technological advancements to enhance capabilities in clinical trial support and data management. In gene editing news, Intellia Therapeutics is advancing towards FDA approval for its in vivo CRISPR therapy following successful Phase 3 trials. This progress heralds a new era for gene editing technologies in treating genetic disorders, underscoring their potential to revolutionize therapeutic approaches. Eli Lilly continues its aggressive acquisition strategy by purchasing Ajax Therapeutics for $2.3 billion. This acquisition focuses on next-generation JAK inhibitors for myelofibrosis, aligning with Lilly's broader goal to diversify its pipeline and maintain its leadership in innovative therapeutics. Recent studies have also shed light on how an endoscopic procedure used in Europe can aid patients on Eli Lilly's tirzepatide in maintaining weight loss post-treatment. This finding could significantly impact long-term obesity management strategies, offering new insights into sustainaSupport the show

Send us Fan MailWater Tower Research's healthcare equity analyst Robert Sassoon breaks down President Trump's executive order on therapeutic psychedelics, examining the five key mechanisms it puts in place — from accelerated FDA review vouchers and right-to-try expansion to federal funding and ibogaine pathway clearance. Sassoon explains what the order gets right, where it falls short (namely on reimbursement and rescheduling), and which companies — including Compass Pathways, Dephinium Therapeutics, and Helus Pharma — stand to benefit most as the sector gains its first clear federal endorsement as a legitimate therapeutic class. 

In der heutigen Folge sprechen die Finanzjournalisten Nando Sommerfeldt und Holger Zschäpitz über Metas Entlassungspläne, Alphabets Emanzipation und gute Nachrichten für Angermayer & Co. Außerdem geht es um Amazon, Block, Marvell, Broadcom, AtaiBeckley, Compass Pathways, GH Research, Cybin, Definium, Tesla, Texas Instruments, Lam Research, IBM, ServiceNow, GE Vernova, Boeing, Rheinmetall, Siemens, Siemens Energy, Caterpillar, Fanuc, Vertiv, First Trust RBA American Industrial Renaissance UCITS ETF (A40ZG6), Amundi S&P World Industrials Screened UCITS ETF (A3DSTE), Xtrackers MSCI World Industrials UCITS ETF (A113FN), iShares MSCI Europe Industrials Sector UCITS ETF (A2QBZ6), L&G ROBO Global Robotics and Automation UCITS ETF (A12DB1), iShares Automation & Robotics UCITS ETF (A2ANH0), Global X Robotics & AI UCITS ETF (A2QPBW), Amundi MSCI Robotics & AI UCITS ETF (A2JSC9), ARK Artificial Intelligence & Robotics UCITS ETF (A408AX), Fidelity Global Industrials Fund (941119), Deka-Industrie 4.0 (DK2J9F). Anzeige: Diese Folge enthält Werbung für Smartbroker+. Depot eröffnen & 60 € ETF sichern! Riesige ETF-Auswahl, flexible Trades & persönlicher Support bei Smartbroker+. Alle Informationen gibt es unter: https://get.smartbrokerplus.de/triple-aaa-podcast/ Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Hier könnt ihr den AAA-Newsletter abonnieren: https://www.welt.de/newsletter/article232797673/Alles-auf-Aktien-Der-taegliche-Boersen-Newsletter-fuer-WELTplus-Abonnenten.html Und - ganz neu: AAA gibt es jetzt auch auf Instagram: https://www.instagram.com/alles_auf_aktien/ Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

In dem Podcast teilt Compass Pathways Gründer Lars Wilde seine Geschichte, gibt Einblicke in die Behandlung von Depressionen und die Geschäftsmodelle dahinter. Compass Pathways hat am 17.02.2026 weitere Ergebnisse ihrer Phase 3 Studie vorgestellt und ist im Austausch mit der FDA über einen verkürzten Zulassungsprozess. Die Markteinführung kann schon Ende 2026 erfolgen. Sollte es zugelassen werden, könnte es eine der schnellst wachsenden Medikamente der letzten Jahrzehnte werden.

At one point in time not too long ago, Weight Watchers was the legacy name in weight loss treatment. Armed with an endorsement from board member Oprah Winfrey, everything was turning up Weight Watchers – until it wasn't.. Usurped by powerful weight loss drugs manufactured by Eli Lilly and Novo Nordisk – along with ascendant telehealth firms like Ro, Hims & Hers, and Noom – Weight Watchers went into significant decline.  Ultimately, even Oprah left the company and donated her shares.  In May 2025, Weight Watchers filed for Chapter 11 bankruptcy in order to eliminate around $1.5 billion in debt. It emerged from bankruptcy in July and now has its sights set on repositioning itself as a key player in the GLP-1 age. But what is Weight Watchers' function in 2026?  This week, managing editor Jack O'Brien is joined by Scott Honken, PharmD, chief commercial officer at Weight Watchers, for an update on the company's current standing in the GLP-1 landscape, where it's been and where it's going. In lieu of our Trends segment, we have some audio takeouts from Jack's time at SXSW, featuring leaders from Amgen, Marina Maher Communications and Compass Pathways. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: 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 pcm.adswizz.com for information about our collection and use of personal data for advertising.

If you followed along with managing editor Jack O'Brien's live blog from SXSW last week, you'll know that he spoke with a number of key medical marketing leaders on the ground in Austin. Those takeouts, including insights from Amgen, Marina Maher Communications and Compass Pathways, will be featured in next week's podcast. For this week's pod, we have an important conversation further tying in pharma brands to the world of sports.  We're joined by Pro Football Hall of Famer Barry Sanders, who serves as a spokesperson for Amgen in its campaign raising awareness about cardiovascular disease, namely LDL, or “bad” cholesterol. Sanders, who suffered a heart attack in 2024, has partnered with the pharma giant to use his stature as the greatest living running back to raise awareness around LDL-C testing. He has starred in The Making of a Heart Attack documentary sponsored by Amgen and also participated in a panel discussion about the issue at SXSW. And for our Trends segment, you'll hear from Jameson Fleming, Steve Madden, Lecia Bushak with a preview of the 2026 MM+M Transform conference scheduled for next Tuesday, March 31 in downtown Manhattan.   Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: 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 pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this week's episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Steve Levine, MD, Chief Patient Officer at Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. One of the areas that Compass Pathways is working in is the development of psilocybin-based treatments for treatment-resistant depression (TRD). Dr. Levine is a board-certified psychiatrist who has spent his career working across multiple facets of the healthcare system to improve people's lives through creating access to innovation. Dr. Levine completed an internship and residency in psychiatry at New York – Presbyterian Hospital/Weill Cornell Medical Center, followed by fellowship subspecialty training in psychosomatic medicine/psycho-oncology at Memorial Sloan Kettering Cancer Center/New York – Presbyterian Hospital. Prior to Compass Pathways, Dr. Levine led Actify Neurotherapies, a company he founded in 2010 that built new models of care delivery across the US for interventional psychiatry treatments. He has published extensively in both peer-reviewed journals and popular media, presented to both professional and lay audiences around the world, served in leadership roles for professional societies and not-for-profit entities and received numerous awards for leadership and service. Tune in to hear about innovations and unmet needs in the mental health space and the development of science-driven psilocybin-based treatments for depression.   For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Send us Fan MailKabir Nath is Chief Executive Officer of Compass Pathways  ( https://compasspathways.com/ ), a biotechnology company pioneering evidence-based psychedelic innovation for serious mental health conditions.Kabir brings nearly three decades of leadership experience across the biopharmaceutical and medical device industries. Before joining Compass, he served as Senior Managing Director of Global Pharmaceuticals at Otsuka Pharmaceutical Co., and previously as President and CEO of Otsuka's North America Pharmaceutical Business, where he led the development of therapies and digital solutions addressing complex mental health needs. Earlier in his career, he held senior leadership roles at Bristol Myers Squibb.Under Kabir's leadership, Compass has advanced COMP360 — a synthetic, proprietary formulation of psilocybin — through two pivotal Phase 3 trials in treatment-resistant depression. The program has demonstrated statistically significant and clinically meaningful reductions in depression severity, potentially positioning COMP360 to become the first FDA-approved psilocybin-based treatment.Kabir holds an MA from the University of Cambridge and an MBA from INSEAD.#PsychedelicMedicine #Psilocybin #DepressionTreatment #MentalHealthInnovation #CompassPathways #COMP360 #TreatmentResistantDepression #Biotech #Neuroscience #FutureOfPsychiatry #ClinicalTrials #MentalHealthResearch #PsychedelicTherapy #BiotechInterview #DrugDevelopmentSupport the show

On this week's episode, Eric Schmidt, Paul Matteis, Sam Fazeli, Graig Suvannavejh, and Luba Greenwood kick off with a discussion on the surge in out licensing deals and growing drug development momentum in China -- a trend they expect will continue. The conversation then shifts to market sentiment, touching on biotech outlook and M&A. in policy news, the group highlights that the FDA reversed its refusal to file a letter for Moderna's flu vaccine after President Trump met with Dr. Marty Makary. They also discuss the FDA's recent regulatory unpredictability, particularly in vaccines and rare diseases. Next, the co-hosts highlight Denali Therapeutics' upcoming PDUFA date for its Hunter syndrome therapy as another test of the FDA's flexibility. The group notes the agency's paper published in NEJM announcing approval of certain drugs based on a single clinical trial, with some viewing it positively for biotech innovation while others caution it may be meaningless, especially with leadership changes. The co-hosts close the discussion on regulatory news by reflecting on positives that have emerged during the Dr. Makary/Dr. Prasad era. In company news, the co-hosts discuss an analysis on the Keytruda patent landscape J&J's investment in a new cell therapy manufacturing plant and data updates from Roche in kidney disease and Compass Pathways' latest psilocybin results. *This episode aired on February 20, 2026.

Bei unserem Partner Scalable Capital gibt's jetzt nicht nur das unserer Meinung nach beste Broker-Angebot in Deutschland. Ihr kriegt auch noch 25 € vom Scalable-ETF, wenn ihr ein neues Konto eröffnet und nutzt. Dazu unterstützt ihr auch noch diesen Podcast. Mehr Infos gibt's hier. Aktivisten stürmen die Börsen: Elliott x Norwegian Cruise Lines, Starboard x TripAdvisor, Jana x Fiserv. Infleqtion-IPO, Raspberry Pi als KI-Geheimtipp, Compass Pathways mit Psilocybin. Warner Bros. x Paramount, Masimo x Danaher. ServiceNow x Management. Hat Bayer (WKN: BAY001) gestern die Lösung der Glyphosat-Krise gefunden? Und wieso steigt die Aktie immer weiter? Wir klären auf. Das ganze Interview mit Bill Anderson zum Bayer-Turnaround findet ihr hier: https://www.youtube.com/watch?v=tAxTJCDPQ08. Diesen Podcast vom 18.02.2026, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

Good 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 breakthroughs and strategic maneuvers that are reshaping the landscape of this dynamic industry.Roche is making waves with its antibody Gazyva, initially recognized for cancer treatment. The company has successfully ventured into autoimmune diseases, targeting kidney conditions. Recent phase 3 trials have reinforced Gazyva's efficacy in treating immune-mediated kidney diseases, building on its prior approval for lupus nephritis. This marks a potential paradigm shift from oncology to autoimmune therapy applications, offering a promising new avenue for treating complex kidney disorders. Such advancements underscore the power of immune modulation in addressing severe health conditions.Turning to oncology, Eli Lilly is expanding the use of its cancer drug, Retevmo. Originally approved for specific lung and thyroid cancers with rare biomarkers, Lilly is now exploring its use in the adjuvant setting for non-small cell lung cancer. This effort reflects a broader trend in oncology: companies are increasingly looking to extend the application of targeted therapies beyond their initial indications. This expansion could significantly enhance treatment options and improve patient outcomes.In ophthalmology, Ocular Therapeutix is preparing for an FDA filing following positive phase 3 results for its wet age-related macular degeneration treatment. Their candidate, AXPAXLI, showed superior efficacy compared to Regeneron's Eylea in head-to-head trials. Despite investor skepticism, Ocular remains confident in its product's potential to impact retinal disease management positively. The competitive landscape in ophthalmology is fierce, and innovative treatments with substantial clinical benefits over existing therapies can redefine standards of care.Eli Lilly is also strategically stockpiling Orforglipron, its oral GLP-1 candidate, in anticipation of FDA approval for obesity treatment. This proactive measure aims to prevent supply chain issues seen during previous GLP-1 launches. It reflects an industry-wide focus on ensuring product availability at launch to meet growing market demand effectively.On the regulatory front, there are significant shifts as well. The Trump administration's renewed pilot of 340B rebates aims to optimize drug pricing frameworks. Novartis has secured a long-term supply agreement with Niowave for Actinium-225 (Ac-225), crucial for developing targeted cancer therapies. This highlights the sustained demand for radiopharmaceutical isotopes as part of precision medicine initiatives.Biopharma funding is expected to recover steadily by 2026, albeit with a cautious approach favoring de-risked assets over broader platform technologies. Venture capitalists prefer predictable returns amidst an evolving market landscape.Now, let's turn to Japan, where Innovacell is planning a $92 million IPO on the Tokyo Stock Exchange. This move signals a renewed interest in biotech within the region after a long drought in IPOs. Financial strategies like these are vital for advancing cell therapies that hold promise for treating conditions once deemed challenging.Gilead Sciences has acquired synthetic lethal therapy from Genhouse Bio through a $1.5 billion deal, further underscoring the growing interest in synthetic lethality as a novel cancer treatment approach. This strategy focuses on targeting tumors while sparing normal cells, offering more effective therapies with fewer side effects.In mental health innovations, Compass Pathways has reported positive results from its pivotal trial using psilocybin for treatment-resistant depression. The success of this phase 3 trial highlights the potential role of psychedelics in psychiatric care and could revolutionize mental health treatments by providing new options Support the show

Last week, the FDA declined to review Moderna's mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad himself signing the refuse-to-file (RTF) letter. Prasad said Moderna's comparator group “does notreflect the best-available standard of care,” while Moderna pushed back, saying CBER had previously found a standard-dose flu shot to be an “acceptable” comparator. Despite the shocking turn of events, HHS backed Prasad, saying Moderna didn't “follow very clear FDA guidance from 2024.”Regardless of the reasons, the development imperilsModerna's breakeven plans, affecting not just the company's investigational flu vaccine but also a flu-COVID combo shot and other parts of the company's pipeline. And for the broader industry, it highlights the regulatory uncertainty that persists into 2026, even as other countries move full speed ahead with novel modalities.That regulatory uncertainty extended this week to DiscMedicine, whose rare disease drug bitopertin was rejectedby the FDA. The company tried to convince investors that its planned Phase 3 trial would pave the way toward a refiling, but analysts raised concerns that the study was developed with oldFDA leadership. Disc's situation also raises questions about the FDA's Commissioner's National Priority Voucher, which bitopertin had received.Meanwhile, Compass Pathways dropped long-awaited data from two Phase 3 trials of its psilocybin-based COMP360, showing strong durability data that “clearly met the Street's bar for success,” according to Stifel analysts. The company plans to complete a rolling new drug application by the end of the year.Finally, the CDC has been left leaderless, again, with the departure of Jim O'Neill, who had been servingas acting director after the ouster of Susan Monarez last summer. And Sanofi's Paul Hudson was removed as CEO last week. He'll be replaced by Merck KGaA's Belén Garijo, who becomes just the second woman in charge of a Big pharmacompany.

On this week's episode, Graig Suvannavejh, Chris Garabedian, Eric Schmidt, and Yaron Werber kick off with a look at a big week for biotech IPOs, led by Veradermics and Eikon Therapeutics. The co-hosts note that this could mark the start of a healthy year for high‑quality IPOs, with many companies entering the market with mature assets Generate Biomedicines' S‑1 filing was highlighted as another positive signal for the industry. The conversation moves to policy, including Amgen's decision not to withdraw Tavneos after the FDA flagged data from a 2021 trial conducted by ChemoCentryx before it was acquired by Amgen. The group also discusses the narrowly passed spending bill that reauthorizes the FDA's rare pediatric disease priority review voucher program and the White House's rejection of fast‑track review for Compass Pathways' psychedelic. In obesity news, the group discusses Dr. Makary's signaling FDA will take action against compound pharmacies following HIMS' announcement that they will provide compounded semaglutide pills. The co-hosts also highlight promising clinical data from Pfizer and Metsera's GLP‑1 program and Amgen's investigational MariTide, which seem to reaffirm each other's data and the competition between Novo and Lilly. There's also discussion on the broader obesity landscape. In company updates, the group covers GSK returning rights to Wave for its lead rare disease asset. The episode concludes with discussion of GSK's decision to hold on a Phase 3 trials for its long‑acting TSLP program and upcoming Ocular Therapeutix wet AMD data. *This episode aired on February 6, 2026. 

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital Markets said in a Tuesday note that the data “look competitive,” analysts clamored for more details on Pfizer's earnings call the same morning—and were left wanting more. Meawhile, Merck batted away accusations of “modest growth” from analysts on its own earnings call, as CEO Robert Davis touted “probably the broadest and widest pipelinewe've had in years.” These calls followed Roche last week and Johnson & Johnson before that, but earnings season is just getting started. On the docket today is Eli Lilly, which has been acquisitive of late, plus Novo Nordisk, Novartis, AbbVie and more.  On the regulatory front, the FDA is expected to decideon eight products this month, including REGENXBIO's Hunter syndrome gene therapy RGX-121. The biotech ran into a regulatory snag last week, however, as the FDA placed a clinical hold on two of its programs, including RGX-121. The agency also launched its much-anticipated PreCheck pilot program, which aims to make it easier for companies to build manufacturing plants in the U.S. And President Donald Trump's TrumpRx platform is delayed, potentially amid anti-kickback concerns.  In ClinicaSpace this week, we took a deep dive intothe resurgent psychedelics space, which could see two companies—Compass Pathways and Definium—submit FDAapplications this year. H.C. Wainwright analyst Patrick Trucchio told BioSpace 2026 is set to be “the biggest year from a clinical data standpoint,” since the firm began covering Compass in 2018. And check your inboxes Wednesday for BioPharmExecutive, where we take a look back at the banner IPO year that was 2021: Where are these companies now?

In this episode, Psychedelic Medicine Podcast host, Dr. Lynn Marie Morski, provides the latest updates from the field of psychedelic medicine. Dr. Morski discusses the breakthrough therapy designation which a number of psychedelic compounds have received in the past few years, the most recent of which is BPL-003, a nasal spray formulation of 5-MeO-DMT. One of the exciting aspects of this new compound, Dr. Morski notes, is that it is shorter-acting than most serotonergic psychedelics—a feature which may make treatment with this substance less expensive and more accessible.  Another exciting development is the COMPASS Pathways phase 3 trial of COMP360 psilocybin. Dr. Morski shares that the company believes they are nine to twelve months ahead of schedule, which means that if all goes well, this psilocybin compound could be approved for treatment resistant depression as early as sometime in 2027. She also discusses why the US FDA said they rejected MDMA for PTSD and what this governing body would like to see from subsequent research before reconsidering this decision. In closing, Dr. Morski shares excitement about the development of novel psychoplastogens—the non-hallucinogenic psychedelics—which may help bring many of the same healing benefits to populations currently unable to be served by the existing compounds under investigation.   In this episode, you'll hear: Which psychedelics currently have breakthrough therapy designation and for which indications Details of recent ketamine research for inpatient depression care and why these results are not as negative as they may seem The current horizons of psychedelic research and what indications may soon be explored Sources of hope in the current state of psychedelic research and the legal landscape   Quotes: "[BPL-003] showed rapid and durable antidepressant outcomes after a single dose. … here we have something that is under an hour [of psychedelic experience] for treatment resistant depression." [7:43] "Keeping patients blinded to whether or not they got the placebo or MDMA is a big focus that [the FDA] wanted to emphasize for these future phase 3 trials." [19:07] "I know we had a big setback last year. I think a lot of us thought by this time we'd be a year into MDMA being approved and we're not. However, there are so many things on the horizon that are worth being excited about." [23:48]   Links: Psychedelic Medicine Podcast on Instagram Psychedelic Medicine Podcast on YouTube Jelovac A, McCaffrey C, Terao M, et al. "Serial Ketamine Infusions as Adjunctive Therapy to Inpatient Care for Depression: The KARMA-Dep 2 Randomized Clinical Trial" JAMA Psychiatry, 2025. Beckley Psytech Limited Phase 2 Trial: BPL-003 Efficacy and Safety in Treatment Resistant Depression COMPASS Pathways Phase 3 Trial: Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD Food and Drug Administration (FDA) Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder Psychedelic Alpha Psychedelic Drug Development Bullseye Chart Psychedelic Medicine Association Porangui

Welcome to the Psychedelic Conversations Podcast!In this episode, we sit down once again with Heather Smith, a certified IFS therapist, consultant, and founder of the Moxie School. Together, we explore the intersection of Internal Family Systems and expanded states of consciousness, discussing how IFS can deepen self-understanding and healing within psychedelic experiences. Heather shares her journey of training facilitators to work with these modalities and reflects on the evolving energy within the psychedelic field — from excitement to a more grounded, mature integration. We also dive into themes of community, trauma healing, embodiment, and spiritual growth, examining how true transformation happens when intellect meets felt experience. This is a deeply reflective conversation about healing, consciousness, and the path of becoming.Our previous conversation:https://youtu.be/Z1RafQmv-zM?si=wqtdOYEWTiSJdlz5About Heather:Heather Smith supports healing and transformation through Internal Family Systems (IFS) Therapy and Psychedelic Integration Therapy. She helps clients connect with their inner healing intelligence to move toward greater clarity, confidence, and calmness—especially those healing from childhood trauma. A Certified IFS Therapist, Heather has completed Levels 1–3 and advanced IFS training programs. She integrates IFS with psychedelic experiences, recognizing how altered states can reveal parts of the self that are ready for healing and transformation.Heather has trained with MAPS, Compass Pathways, and Fluence, and currently serves as a therapist on the MAPS Expanded Access study of MDMA-Assisted Psychotherapy for PTSD at the Aquilino Cancer Center in Rockville, MD. Passionate about education and harm reduction, Heather shares insights on the safe, intentional use of psychedelics and the power of IFS as a pathway to deep healing. She envisions a future where these tools are legal, respected, and accessible for those seeking true wellbeing.Connect with Heather:- Website: https://moxieschool.com/- LinkedIn: https://www.linkedin.com/in/heathersmithlpcThank you so much for joining us! Psychedelic Conversations Podcast is designed to educate, inform, and expand awareness.For more information, please head over to https://www.psychedelicconversations.comPlease share with your friends or leave a review so that we can reach more people and feel free to join us in our private Facebook group to keep the conversation going. https://www.facebook.com/groups/psychedelicconversationsThis show is for information purposes only, and is not intended to provide mental health or medical advice.About Susan Guner:Susan Guner is a holistic psychotherapist with a mindfulness-based approach grounded in Transpersonal Psychology, focusing on trauma-informed, community-centric processes that offer a broader understanding of human potential and well-being.Connect with Susan:Website: https://www.psychedelicconversations.com/Facebook: http://www.facebook.com/susan.gunerLinkedIn: https://www.linkedin.com/in/susan-guner/Instagram: http://www.instagram.com/susangunerTwitter: http://www.twitter.com/susangunerBlog: https://susanguner.medium.com/Podcast: https://anchor.fm/susan-guner#PsychedelicConversations #SusanGuner #HeatherSmith #PsychedelicPodcast #Microdosing #PsychedelicScience

In recent years, there has been renewed interest in psychedelic treatment for a variety of medical conditions ranging from depression to trauma, and even dementia, which has left countless people searching for real recovery. This exciting research is challenging the limits of what's possible. Psychedelic compounds, once misunderstood or dismissed, are now being studied for their ability to promote neuroplasticity, neurogenesis, and reduction in inflammation. In this episode of Trending Health, we're joined by three individuals who are passionate about the growing clinical utility of psychedelic treatments. However, with these treatments, it is critical to think about how to put the patient in the middle and engaged with their treatment to help ensure optimal outcomes: Varun Renjen, a partner at Inizio Putnam and a physician who has been supporting biopharma clients as a strategy consultant for the past 15 years; especially in neurological diseases; Steve Levine, Chief Patient Officer at Compass Pathways and board-certified psychiatrist who has spent his career working to improve people's lives through creating access to innovation in mental health;  Daniel Carcillo, a former NHL hockey player who developed Traumatic Brain Injury (TBI) and depression from the sport who has been successfully treated with psychedelic therapy as a patient and is an advocate for access to psychedelic treatment for brain injury Tags: healthcare, psychedelics, psilocybin, mushrooms, concussions, traumatic brain injuries, depression, mental health, medical affairs Panel – Varun Renjen, Steve Levine, Daniel Carcillo Recording & Editing – Mike Liberto For additional discussion, please contact us at TrendingHealth.com.

Now in its second season, this exclusive CNS Summit podcast series features biopharma leaders sharing bold ideas, breakthrough innovations and what it takes to move smarter and faster for patients. Compass Pathways CEO Kabir Nath joins host, Dr. Alex Wise, Global Head of Neuroscience at Syneos Health, to discuss the clinical promise of psychedelics and what's next for psychiatric innovation.  What you'll learn: What's driving the momentum behind psilocybin therapy Why investor confidence is growing in mental health biotech How biopharma can better communicate the value of innovation Kabir's message to next-gen leaders in science and strategy The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Talking with Marcel Dumas about his ‘Gang Weed Conservatism' series concerning the intertwining of modern conservatism with psychedelics. Vital Dissent website Join my email list and become a premium member: http://www.vitaldissent.club Vital Dissent Merch 10% off with code VD10 Show notes:  Marcel Dumas, PhD, IWSB

Dr. Nick Brüss, EdD, LMFT, is a leading expert in psychedelic-assisted therapy and a licensed therapist. He serves as a clinical researcher and supervisor on the FDA phase III MAPS trial using MDMA for PTSD and is the lead therapist on Compass Pathways' psilocybin trial for treatment-resistant depression. A specialist in Internal Family Systems therapy, Dr. Brüss has shared his work at UCLA and Yale. He's also a certified mindfulness facilitator and Compassion Cultivation teacher, blending science, compassion, and innovation in healing. In This EpisodeNick's websiteYou can learn more about what I do here:The Trauma Therapist Newsletter: celebrates the people and voices in the mental health profession. And it's free! Check it out here: https://bit.ly/4jGBeSaThe Trauma Therapist Podcast:  I interview thought-leaders in the fields of trauma, mindfulness, addiction and yoga such as Peter Levine, Pat Ogden, Bessel van der Kolk and Bruce Perry. https://bit.ly/3VRNy8zBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-trauma-therapist--5739761/support.

Up to 3,500 FDA staffers received their final walking papers Monday after the U.S. Supreme Court found last week that the government is “likely to succeed” in arguing that its overhaul of HHS is “lawful.” Meanwhile, FDA Commissioner Marty Makary floated policy changes for the agency, including a proposal to lower prescription drug user fees for the next iteration of the program, and one to offer speedier reviews to companies willing to lower the cost of their drugs.  Last week, the regulator opened its cache of complete response letters (CRLs), offering transparency into the rationale behind more than 200 recent rejections for ultimately approved therapies, including those for Eli Lilly's Alzheimer's drug Kisunla and Sarepta's Duchenne muscular dystrophy (DMD) treatment Vyondys 53. The FDA did not, however, release the CRLs for two new rejections: those of therapies from Ultragenyx and Capricor Therapeutics in Sanfilippo syndrome type A and cardiomyopathy associated with DMD, respectively. It was an especially rough week for Ultragenyx, which also, along with partner Mereo BioPharma, released seemingly negative Phase II/III data for their osteogenesis imperfecta therapy.  On a more positive note, two bustling therapeutic spaces continue to see positive data. In obesity, Hengrui Pharma's Kailera Therapeutics–partnered dual GLP-1/GIP receptor agonist elicited 17.7% average weight loss in a pivotal Chinese trial. And the psychedelic therapeutics space is again generating excitement with two recent positive readouts in treatment-resistant depression. BioSpace took a deep dive into the market reaction to these readouts for Compass Pathways and Beckley Psytech and atai Life Sciences, and what exactly investors are looking for in a successful psychedelic therapy.  Finally, we examine the progress of AI biotech unicorns and kick off our series on women in biopharma with profiles on Mayo Venture Partner Audrey Greenberg and the all-female CEO/R&D tandem at Acadia Pharmaceuticals.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda has taken the lead in the race for a narcolepsy treatment with back-to-back phase III wins for their drug Oveporexton. Investors are eagerly awaiting breakthroughs in using psychedelics to treat depression. Ultragenyx faced a setback as the FDA rejected their gene therapy for Sanfilippo syndrome, citing manufacturing issues. The FDA is considering speeding up reviews for companies that promise to lower drug costs. Market reaction to recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression shows the challenges psychedelic therapies must overcome for commercial viability. Rainin Micropro offers a solution to streamline NGS preparation with their 96-channel pipettor. The industry is also focused on precision diagnostics to support precision therapeutics in the future. AstraZeneca's Baxdrostat showed promising results in lowering blood pressure in a phase III trial. The ADA revealed R&D priorities for potential blockbuster obesity treatments. Relmada has abandoned development of a depression drug after three failed attempts.The challenges faced by psychedelic therapies in the treatment of depression are discussed, as recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression have left investors wanting more. The market reaction highlights the hurdles psychedelic therapies must overcome to prove their commercial viability. Additionally, the importance of precision diagnostics in the development of next-generation precision oncology therapies is emphasized, stating that only with the adoption of digital imaging and AI-powered analysis will these therapies reach their full potential. The FDA has several important decisions lined up, including applications in lymphoma, rare diseases, and hormone deficiency, while the American Diabetes Association's annual meeting reveals R&D priorities for weight loss medicines. Topics discussed include Capricor's FDA rejection of a DMD cell therapy, the ALS community petitioning the FDA to reconsider Brainstorm's Nurown, and updates on COVID-19 vaccines and Alzheimer's drugs. Upcoming webinars and job opportunities in the biopharma industry are also included.

The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act's requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by HHS Secretary Robert F. Kennedy Jr.Speaking of HHS committees from which members have been removed at will by Kennedy, the CDC's revamped Advisory Committee on Immunization Practices convened last week for its first meeting since the roster overhaul, where a vote on Merck's recently approved RSV-targeting monoclonal antibody Enflonsia and a discussion around the inclusion of preservative thimerosal in influenza vaccines was on the docket, but an expected vote on Moderna's mRNA-based RSV shot mRESVIA was not.Also dominating the headlines on Friday was the FDA's decision to remove the Risk Evaluation and Mitigation Strategies (REMS) program from the six approved CAR T therapies it was applied to. Analysts and patient groups lauded the move, which is expected to potentially double access to these life-saving therapies, saying it reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”Willliam Blair noted that it could be a “positive signal” to companies developing CAR T therapies for autoimmune diseases, which now includes AbbVie. In an all-cash buyout on Monday, the Illinois-based pharma dropped $1.2 billion for Capstan Therapeutics and its in vivo edited CAR T therapy for B cell–mediated autoimmune diseases. M&A has been on an uptick of late, and private equity companies—such as those that snapped up bluebird bio—are also getting in on the game.Finally, after Lykos Therapeutics' high profile failure last summer, the psychedelics space is heating up once again. While a Phase III readout of Compass Pathways' psilocybin drug last week in treatment-resistant depression received a muted reaction from investors, the response to a Phase II readout for Beckley Psytech and atai Life Sciences' intranasal psychedelic was more positive.

The Trump administration's overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury's analysts assess who the winners and losers are likely to be as FDA changes shape.The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656341#biotech #biopharma #pharma #lifescience #RandD #drugapproval00:01 - Sponsor Message: ICON Biotech02:26 - BioCentury Grand Rounds Europe05:02 - FDA's Future15:03 - Psychedelics22:53 - Esobiotech's Fast Exit31:37 - Molecular Glues and CDK234:43 - Abbvie's Capstan BuyTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for June 16-22, 2025: Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT Trial Topline phase 2b data show pemvidutide achieved significant rates of MASH resolution and fibrosis improvement alongside meaningful weight loss at 24 weeks, positioning it as a promising candidate for metabolic liver disease treatment. FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis The FDA approved a belimumab autoinjector for at-home subcutaneous use in children as young as five with active lupus nephritis, providing the first approved biologic self-injection option for pediatric SLE and LN. Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial Hypertension Positive phase 3 results show sotatercept-csrk added to background therapy reduced time to clinical worsening events in adults with PAH, supporting its potential as an effective treatment for this high-risk population. Compass Pathways' COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial COMP360 psilocybin demonstrated a significant reduction in depression symptom severity in treatment-resistant depression, meeting the primary endpoint in a pivotal phase 3 trial. Once-Monthly Obesity Drug, MariTide, Achieves Weight Loss Up to 16% at 1 Year Phase 2 data indicate once-monthly MariTide induces substantial weight loss of up to 16% over one year, with additional improvements in glycemic control, highlighting its promise for obesity and type 2 diabetes management.

On this week's episode, Josh Schimmer, Paul Matteis, Eric Schmidt and Yaron Werber kick off with an optimistic view of the current biotech state of affairs, citing the FDA is open for business, we're seeing companies successfully launch and M&A is happening, though the Trump Administration's Most Favored Nation plan still looms. In regulatory news, UroGen's FDA approval of Zusduri for tumor ablation in recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer was seen as a sign the FDA is continuing to be flexible and business as usual. Where it's not business as usual, concerns were raised about RFK Jr.'s dismantling of the ACIP and worry for the future of vaccine practices. With a continued amount of investor activism against boards, the group opined on ADAR1's letter to Keros' board and Deep Track's battle with Dynavax. The group shared some excitement around the emerging field of psychedelics, including a bullish perspective on Compass Pathways' upcoming data readout. The conversation shifts to questions about biotech's current focus on M&A versus building large companies. The episode concludes with EULAR and EHA conference updates and the favorable data sets coming out of those meetings, leading to a discussion on what's holding CAR-T valuations back in the I&I space. *This episode aired on June 13, 2025.

Shownotes   Exactly what Internal Family Systems therapy is The actual mechanism that creates the most profound level of healing Psychedelics as a loving catalyst to know ourselves more The truth about psychedelic stigma Why it's important to prepare your set and setting with psychedelics The difference between doses of psilocybin   Bio   Nick Brüss, EdD, LMFT, is a leading licensed psychedelic therapist, researcher and educator who is passionate about inspiring and helping people heal, grow and live creative lives. He's pioneering treatments and programs that harness the synergistic power of combining psychedelic medicine with cutting edge therapy and coaching.    Dr. Brüss was a clinical researcher and supervisor on the ground breaking FDA Phase III clinical trial of MDMA-assisted therapy for PTSD sponsored by MAPS, and is currently a lead therapist on the Phase III Psilocybin therapy study for Treatment Resistant Depression sponsored by Compass Pathways.    In private practice, he specializes in concierge ketamine-assisted and Internal Family Systems (IFS) therapy. He trains nationally and speaks internationally on psychedelic-assisted therapy safety and efficacy, and is a co-founder of the Psychedelic Coalition for Health, a psychedelic medicine education and training platform.    Dr. Brüss is also a Certified Mindfulness Facilitator through UCLA's Mindful Awareness Research Center at the Semel Institute for Neuroscience and Human Behavior, and a certified teacher of both Mindful Self-Compassion, and the Compassion Cultivation Training through the Center for Compassion, Altruism Research and Education at Stanford University School of Medicine.   Find more about Dr. Brüss' work at www.apracticeoffreedom.com and connect with him on LinkedIn and Instagram. Timestamps   00:01:14 - Guest introduction 00:02:20 - How Layla and Dr. Brüss originally connected 00:04:51 - Sign up for Layla's newsletter at LaylaMartin.com 00:06:51 - The first time Layla experienced her own somatic avoidance 00:11:14 - Humans are so beautiful when they don't have so much pain 00:13:52 - Dr. Brüss explains what Internal Family Systems therapy is 00:19:24 - Unlock your deepest passion inside The Tantric Mastermind for Couples 00:20:06 - Discover your most masculine confidence and presence with Men's Sexual Mastery 00:21:12 - Dr. Brüss introduces listeners to MAPS 00:24:36 - The actual mechanism that creates this profound level of healing 00:27:19 - Layla shares about her experiences with MDMA 00:30:43 - How IFS integrates with felt-sense experience 00:32:30 - How intellectually “getting” something isn't the same as being “in” it 00:36:33 - We don't realize how much power we actually have 00:38:44 - Discover MOOD™ Sex Magic 00:42:48 - How psychedelics can be a loving catalyst to know ourselves more 00:44:28 - Layla shares her experience with psychedelics 00:47:22 - Dr. Brüss and Layla drink MOOD Sex Magic 00:55:28 - Psychedelic stigma was intentionally created 00:57:02 - The war on disconnection 00:57:27 - Enhance your sensitivity and pleasure inside Crystal Pleasure 00:59:15 - Why it's important to prepare your set and setting with psychedelics 01:04:33 - Dr. Brüss shares about his first psychedelic experience 01:07:24 - The difference between doses of psilocybin 01:12:06 - How different psychedelics work on different situations 01:19:53 - Conclusion  

دکتر آهو یارا، PhD، که پیش‌تر به نام صدف لطف‌علیان شناخته می‌شد، روان‌شناس بالینی و روان‌درمانگر با استفاده از روان‌نماها است. او در حوزه پزشکی روان‌نما با نهادهایی از جمله COMPASS Pathways و دانشکده پزشکی دانشگاه جانز هاپکینز آموزش دیده است، جایی که در جلسات سیلوسایبین به‌عنوان راهنمای همکار حضور داشته است. آهو در نهادهایی مانند خدمات مشاوره و روان‌شناختی دانشگاه UCLA درباره کاربرد درمانی روان‌نماها آموزش داده است.او آموزش‌های پیشرفته‌ای در رویکردهای مبتنی بر شفقت برای بهبود دارد و مربی تایید‌شده‌ی چی‌گونگ و پرانایاما است. او برنده کمک‌هزینه‌ای از ائتلاف پزشکی روان‌نما برای کارهایش در راستای اطمینان از رعایت بهترین شیوه‌ها توسط راهنمایان و مشارکت‌کنندگان در حوزه روان‌نماها شده است. آهو مدافع خرد بومی، حقوق و حفاظت از آن است و خود را وقف بهبود بازسازی‌کننده‌ی جهان طبیعی کرده است.آهو در تهران متولد شد و تا سن ۱۳ سالگی در آنجا زندگی کرد. از آن زمان، خود را به‌عنوان یک مهاجر ایرانی در مکان‌هایی از جمله استکهلم، ونکوور، بالتیمور، نیویورک، واشنگتن دی‌سی، لس‌آنجلس و اخیراً لیسبون، پرتغال شناخته است. امید او این است که افراد فضاهای امنی برای دیده‌شدن و حمایت در داستان‌ها، آسیب‌پذیری‌ها و تاب‌آوری‌هایشان داشته باشند.برای آشنایی بیشتر با آهو یارا و کارهاش می‌تونید به وبسایت یا اینستاگرمش سر بزنید:https://bio.site/ahooyarahttps://www.instagram.com/ahooyarahttps://www.instagram.com/mehran_somahttps://www.instagram.com/ravannamacommunityhttps://www.somaretreats.org Hosted on Acast. See acast.com/privacy for more information.

In the first episode of Medical Ethics Unpacked, hosts Steve Levine, MD, and Dominic Sisti, PhD, examine the profound ethical and clinical challenges surrounding medically assisted suicide, or medical assistance in dying (MAID), for individuals with severe psychiatric conditions. Dr. Sisti, an associate professor at the University of Pennsylvania, interrogates pivotal questions central to this debate, including whether psychiatric disorders can be deemed terminal and whether individuals with such conditions possess the requisite capacity to make autonomous decisions regarding MAID. Drawing on data from jurisdictions such as Belgium and the Netherlands, he highlights critical concerns, including gender disparities, inconsistent capacity evaluations, and the societal risks of expanding access to psychiatric euthanasia without addressing structural deficiencies, such as inadequate mental health care systems or pervasive social inequities. Dr. Levine, a psychiatrist, explores the complex and dynamic nature of capacity assessments, emphasizing the episodic and often treatable trajectory of psychiatric conditions such as major depressive disorder and anorexia nervosa. He reflects on the potential for recovery facilitated by novel treatments, such as ketamine or psychedelics, juxtaposed with the limitations and gaps in current psychiatric care. Together, the hosts deliberate on the ethical implications of mandating exhaustive treatment attempts, including experimental options, before permitting MAID, balanced against the imperative to respect patient autonomy. Through a rigorous and nuanced discussion, Drs. Levine and Sisti advocate for the establishment of robust ethical frameworks, equitable practices, and comprehensive capacity evaluations. Their discourse challenges societal and professional norms, encouraging reflection on autonomy, human suffering, and the intrinsic value of life in the context of this ethically fraught issue. Relevant studies and documentation mentioned in this episode: Doernberg, Samuel N., John R. Peteet, and Scott YH Kim. "Capacity evaluations of psychiatric patients requesting assisted death in the Netherlands." Psychosomatics 57, no. 6 (2016): 556-565. Kim, Scott YH, Raymond G. De Vries, and John R. Peteet. "Euthanasia and assisted suicide of patients with psychiatric disorders in the Netherlands 2011 to 2014." JAMA psychiatry73, no. 4 (2016): 362-368. Kious, Brent M., and Margaret Battin. "Physician aid-in-dying and suicide prevention in psychiatry: A moral crisis?." The American Journal of Bioethics 19, no. 10 (2019): 29-39. Nicolini, Marie E., Scott YH Kim, Madison E. Churchill, and Chris Gastmans. "Should euthanasia and assisted suicide for psychiatric disorders be permitted? A systematic review of reasons." Psychological medicine 50, no. 8 (2020): 1241-1256. Nicolini, Marie E., Chris Gastmans, and Scott YH Kim. "Psychiatric euthanasia, suicide and the role of gender." The British Journal of Psychiatry 220, no. 1 (2022): 10-13. Sisti, Dominic, J. John Mann, and Maria A. Oquendo. "Suicidal behaviour is pathological: implications for psychiatric euthanasia." Journal of Medical Ethics (2024). Relevant disclosures for Sisti include Lykos Therapeutics and Tactogen. Relevant disclosures for include Levine include Compass Pathways. Chapters 00:00 - Introduction 00:45 - Key Issues in the Debate on Euthanasia and Mental Illness 07:25 - Clinical Perspective on Capacity and Competence 12:45 - Challenges in Evaluating Capacity in Mental Illness 19:32 - Treatment Options and the Role of Social Structures 26:35 - The Parity Between Mental and Physical Illness 31:41 - Requiring Treatment Before Considering Euthanasia 34:44 - The Complexity of Egosyntonic Psychiatric Conditions 37:52 - The Potential for "Terminal Addiction" 43:05 - The Societal Impact and Implications of Psychiatric Euthanasia

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novo Nordisk's weight loss drug Wegovy showed significant improvement in liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis in a Phase III trial. Bristol Myers Squibb reported strong third-quarter results, while Regeneron had mixed sales results. Eli Lilly's third-quarter miss highlights their dependency on wholesaler stocking decisions. Lexicon lost an FDA advisory committee vote, and Merck lowered its full-year sales guidance despite strong Q3 results. Compass Pathways is laying off 30% of its employees. Novartis received FDA approval for Scemblix in certain CML patients. Opportunities for job seekers are available in the biotech industry.

In this episode of The Psychedelic Podcast, Paul F. Austin welcomes Dr. Stephen Thayer, a clinical psychologist and lead trainer for psychedelic therapists at Numinus. Find episode links, summary, and transcript here: https://thethirdwave.co/podcast/episode-262-stephen-thayer-phd/?ref=278 Dr. Thayer shares his journey from military psychologist to psychedelic-assisted therapy specialist, discussing his personal experiences with ketamine and psilocybin. He explores the integration of psychedelics into therapy and coaching, highlighting the distinctions between these roles. Dr. Thayer emphasizes the importance of facilitator training and personal psychedelic experiences, making a compelling case for evidence-based psychedelic mental healthcare alongside ceremonial or spiritual contexts. Note: This conversation was recorded in May 2024, prior to the FDA's decision on Lykos Therapeutics' MDMA-assisted therapy clinical trial for PTSD. The recent FDA ruling, which requested additional studies, will impact some of the information discussed regarding MDMA's path to medical approval. However, we believe this episode remains valuable for its insights into the broader landscape of psychedelic therapy, practitioner training, and the ongoing evolution of the field. Enjoy! Dr. Steve Thayer, Ph.D. is a clinical psychologist who specializes in psychedelic-assisted therapy practice, training, and research. He began his career in the U.S. Air Force where he led mental health care teams, provided therapeutic and assessment services, and counseled military leadership about community mental health concerns. As an adjunct professor, Dr. Thayer has taught graduate and undergraduate courses in counseling skills, clinical psychology, and personality theory. He has served as the lead therapist on several psychedelic medicine clinical trials and currently consults for Compass Pathways as a mentor to the therapists working on their phase 3 trial of psilocybin for treatment-resistant depression. Dr. Thayer is the Lead Instructor for Numinus's psychedelic-assisted therapy certification program and co-hosts Numinus's podcast, Psychedelic Therapy Frontiers. Dr. Thayer has a private therapy and coaching practice where he helps people resolve the unconscious blocks keeping them from creating the happiness, wealth, freedom, and relationships they crave. Highlights: From military psychology to psychedelic therapy Personal explorations with ketamine and psilocybin Psychedelics for mental health and spiritual exploration Integrating psychedelics into therapy and coaching Motivation for entering the psychedelic industry Bringing psychedelic awareness to the unconscious mind The potential for harm in the psychedelic underground Principles of effective psychedelic facilitation Assessing personal readiness as a psychedelic facilitator Experiential MDMA training for therapists Balancing evidence-based and spiritual approaches Episode Sponsors: Apollo Neuro - Third Wave listeners get 15% off. Soltara Healing Center: Use code TW200 to receive $200 off your next retreat.

Jason Najum has covered the psychedelic space for a long time and contextualizes recent news around the FDA, MDMA, PTSD and Lykos Therapeutics (1:35). Recent news a blessing in disguise for Cybin, COMPASS Pathways and MindMed (14:30)? Trial data and cash in the bank are top signifiers of success (22:35). How Atai fell behind and dropped out of the conversation (24:00). Upcoming catalysts - patience required (26:35). For psychedelic medicine, does it matter who's in the White House (29:30)?Read episode transcriptsShow Notes:FDA's MDMA Decision A Setback, But Long-Term Outlook For Psychedelic Stocks UnchangedMindMed: Despite MDMA Setback, Still Hope In Light Of Differentiating FactorsATAI: Enormous Potential Upside But No Clarity YetDe-Risking Psychedelics: Compass Pathways, Cybin And AtaiFor full access to analyst ratings, stock quant scores and dividend grades, subscribe to Seeking Alpha Premium at seekingalpha.com/subscriptions

In this next episode of The Heidrick & Struggles Leadership Podcast, Heidrick & Struggles' Charlie Moore speaks to Kabir Nath, the CEO of Compass Pathways. Compass Pathways is a company dedicated to studying investigational psilocybin treatment in treatment-resistant depression, post-traumatic stress disorder, and anorexia. Kabir Nath, whose career has spanned approximately 30 years in the biopharmaceutical and medical device industry, was previously the senior managing director of the global pharmaceutical company Otsuka Pharmaceuticals. In this conversation, Nath shares what attracted him to the biotech space and what it's like to take over the helm of a company from founders, and how he's collaborated with them during the transition. He also discusses his perspective on healthcare accessibility, evolving an organizational culture as the business grows, what new skill sets or capabilities he is looking for in talent, and how he manages investor relations. Finally, he shares how he is preparing the leadership team for the organization's continued transformation over the next few years. Hosted on Acast. See acast.com/privacy for more information.

Let's celebrate. This is episode 100! My guest is Jonathan Sabbagh, Co-Founder of Journey Clinical and I talk about normalising Ketamine therapy for all, plus why PTSD can fire up your career - until you realize it is harmful to you. Since a few years I am following Jonathan and his wife and Co-Founder Myriam Barthe's great work around the idea to build a strong, decentralized network and offerings for KAP (Ketamine Assisted Psychotherapy) to empower as much therapists as possible to execute the therapy. They did an incredible and successful job to make Ketamine therapy available and build a strong system in collaboration with therapists and doctors.In this episode is talk to Jonathan about: -how PTSD can give you a skyrocketing career, until you realiize your “energy” is trauma in disguise-how we both were very good in PTSD friendly jobs (banking & media) and left them because we realised our own PTSD -how Journey Clinical helps therapists to support their patients with ketamine therapy, (eventually psilocybin) if they are interested in trying and why normal “therapy” needs a strong transformation What Journey Clinical doesJourney Clinical is on a mission to transform the growing mental health crisis by accelerating the mainstream adoption of legal, evidence-based Psychedelic-Assisted Psychotherapy as the standard of care for mental health, starting with Ketamine-Assisted Psychotherapy. They have built a leading platform for Psychedelic-Assisted Psychotherapy in the US. They also recently announce a research collaboration agreement with Compass Pathways to inform the development of a scalable delivery and training model for COMP360 psilocybin treatment. Which means, together with Compass, they work on a future delivery model for psilocybin therapy. INFO@journeyclinical @Jonathansabbaghwww.https://www.journeyclinical.com/. Hosted on Acast. See acast.com/privacy for more information.

In this episode of the Psychedelic Medicine Podcast, Dr. Hans Eriksson joins to discuss the potential of non-dissociative ketamine. Dr. Eriksson, Chief Medical Officer at HMNC Brain Health, is a highly respected drug developer and clinical psychiatrist with over 20 years of pharmaceutical experience. Prior to HMNC Brain Health, Dr. Eriksson served as Chief Medical Officer at COMPASS Pathways and previously as Senior Director of Clinical Research at Lundbeck and Medical Science Director at AstraZeneca. In this conversation, Dr. Eriksson shares what inspired him to move from clinical practice to drug development, and why he sees so much potential in developing non-dissociative forms of ketamine. He discusses the ways the dissociative effects of ketamine decrease the accessibility of this treatment due to the fact that these changes in perception are undesirable for a significant portion of patients. Dr. Eriksson also shares results from preliminary studies of non-dissociative ketamine which showed efficacy in inducing anti-depressant effects. In closing, Dr. Eriksson discusses why he thinks the experiential element of the classical psychedelics play an important role in their efficacy as mental health treatments, but why this might not be the case when it comes to ketamine.    In this episode you'll hear: The history of ketamine The pharmacology of ketamine's dissociative effect The relationship between ketamine dose and antidepressant effect  The possibility of bladder issues and addiction with ketamine and whether non-dissociative forms of ketamine would also have these potentials How Dr. Eriksson thinks about combining psychotherapy with ketamine treatments   Quotes: “We are aiming for a similar exposure to the drug as you achieve with, for instance, an intravenous administration, but we are achieving a much lower peak concentration, maximum concentration of the compound. So that is one of the characteristics of our formulation.” [10:58] “Our view is that it's probably better to try to use the metabolism in the body as a tool to achieve very low exposure to ketamine but high exposure to the downstream metabolites.” [23:19]   Links: Dr. Eriksson on LinkedIn HMNC Brain Health on LinkedIn HMNC Brain Health website Previous episode: Potential Benefits of Non-Hallucinogenic Psychedelics with Kurt Rasmussen, PhD Psychedelic Medicine Association Porangui

Sunny Strasburg, LMFT and I discuss the benefits that Ketamine and other psychedelics have provided and continue to provide people who struggle with depression, anxiety, PTSD and more. We talk about how and why this works scientifically as well as go through the entire process of what patients can expect. Sunny Strasburg, LMFT is certified in Psychedelic Assisted Psychotherapy by the California Institute of Integral Studies. She has been trained in psilocybin therapy by Compass Pathways and Synthesis. She is also a trainer for the Theradelic Approach, and hosts KAP retreats. Mrs Strasburg serves as a consultant for licensed practitioners. Follow Sunny at: sunnystrasburgtherapy.com IG: @sunnystrasburglmft Her Book: The Theradelic Approach

In a recent insightful interview, George Goldsmith, the visionary entrepreneur and founder of Compass Pathways, shared the rich tapestry of his life and career. He has had a journey that unfolded in unexpected ways, defying conventional norms.

In this episode, Melanie Pincus, Ph.D. and Manesh Girn, Ph.D. once again take over hosting duties, this time interviewing Gül Dölen, MD, Ph.D.: Associate professor of Neuroscience and Neurology at the Johns Hopkins University, School of Medicine, and head of the Dölen lab. Dölen largely researches the neuroscience behind social behaviors and is most known for her work in establishing how psychedelics reopen critical periods of learning, and that the true benefit of psychedelics could be in learning how best to reopen those critical periods, how long they're open for, and which therapeutic frameworks and integration practices could best take advantage of them. Her most recent research was giving MDMA to otherwise very asocial (and violent) octopuses to prove that a drastically different species would exhibit typical MDMA-inspired prosocial behavior. And, after discovering that all the classic psychedelics worked to reopen critical periods – that psychedelics are apparently the master key to opening these periods – she's now researching why, through the PHATHOM project (Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability). You will likely learn a ton in this episode: why critical periods close as we get older and what may impede them from opening more often; how plasticity and metaplasticity relate to each other and why increased neuroplasticity isn't always a good thing; how the length of different psychedelic experiences relates to efficacy; why the different results of MAPS' and Compass Pathways' studies show the importance of therapy; how autism could be related to critical periods; why repeated psychedelic use may make it harder for one's brain to reset; and how important context is in the ability to reopen critical periods – especially around social learning. Click here to head to the show notes page. 

In this episode of the Psychedelic Podcast, Paul F. Austin welcomes Christian Angermayer, a serial entrepreneur and investor in psychedelics, longevity, fintech, crypto, and future tech. Get full show notes, links, and transcript here: https://thethirdwave.co/podcast/episode-207-christian-angermayer/ Christian is a notable figure in the field of psychedelic medicine, both respected and controversial. He has been a driving force in pushing psilocybin toward FDA-approval. But his company atai Life Science's psychedelic patents have drawn criticism from decriminalization-first advocates. Some wonder if the medical approach to psychedelics conflicts with the idea of open access and shamanic usage. Christian delves into this question, examining opposing views and exploring other dichotomies, such as whether capitalism and spirituality can coexist in the realm of psychedelics. He also considers the potential conflict between the search for psychedelic wisdom and the desire for immortality. Christian's conversation with Paul presents a new perspective on psychedelics, exploring nuanced topics and questioning the future of psychedelic biotech, microdosing, and longevity science. Christian Angermayer: Christian Angermayer is a serial entrepreneur and investor who builds and invests in companies that are shaping the Next Human Agenda: a future in which technology empowers people to live longer, healthier, and happier lives. Christian's family office and private investment firm, Apeiron Investment Group, has more than USD 2.5 billion under management and 50 people across five international locations. Apeiron focuses on Life Sciences, FinTech & Crypto, Future Tech and Experiences, and Hospitality & Happiness. Over the past 20 years, Christian has founded three unicorns and has been the lead investor in four unicorns and two decacorns. Christian is the world's largest investor in psychedelics and is recognized for leading the current psychedelics renaissance. He founded atai Life Sciences, investigating the potential of psychedelic compounds including psilocybin, ketamine, DMT, and ibogaine as approved medical treatments. Highlights: Exploring psychedelics and the evolution of organized religion. The parallels between ancient psychedelic traditions and modern medicalization. An argument for democratizing psychedelic access through centralization. Christian's thoughts on creating a regulated framework for microdosing. Optimism about longevity research and extended lifespans. Overcoming deeply-rooted fears and embracing the concept of a long life. Christian's challenges and successes at COMPASS Pathways & atai Life Sciences. The obstacles of commercializing psychedelic medicines in an economic downturn. Investigating how psychedelics might contribute to longevity. How psychedelics can help us find and live our Dharma (life's purpose). Key Links: Apeiron Investment Group: https://apeiron-investments.com/ atai Life Sciences: https://atai.life/ COMPASS Pathways: https://compasspathways.com/ Episode Sponsors: Apollo Neuro. Third Wave listeners get 15% off. Third Wave's Mushroom Grow Kit - use code 3WPODCAST to save $75.

Graham Pechenik, founder and patent attorney at Calyx Law, joins The Psychedelic Podcast to delve into the complex world of patents and their impact on the psychedelic landscape.  Find episode links, summary, and transcript here. Pechenik raises thought-provoking questions about the patent system's role in fostering innovation while also potentially hindering research and restricting use. He suggests that the patent system, intertwined with regulatory and healthcare structures, often determines whether groundbreaking substances like psilocybin gain FDA approval. Pechenik also explores concerns surrounding excessive psychedelic patents, comparing the unique approaches of COMPASS Pathways, MAPS, and Paul Stamets.  As the episode unfolds, Graham and Paul contemplate the delicate balance between patent protection and freedom of use in the burgeoning psychedelics industry. Graham Pechenik is a registered patent attorney and the founder of Calyx Law, a law firm specializing in cannabis and psychedelics-related intellectual property.  Graham has a BS from UC San Diego, where he chose Cognitive Neuroscience and Biochemistry majors—after his first psychedelic experiences inspired a deep curiosity about the bases for changes in consciousness—and a JD from New York University, where he initially pursued interests in bioethics and cognitive liberty.  After a decade at large law firms defending and challenging patents for Fortune 500 companies across the agricultural, chemical, pharmaceutical, biotech, and technology industries, including working on several landmark patent cases both at trial and on appeal, Graham started Calyx Law in 2016 to help cannabis and psychedelics ventures design and implement their IP strategies.  Graham is also editor-at-large of Psychedelic Alpha, where he writes about psychedelics IP, provides data for patent trackers, and maintains a psychedelics legalization and decriminalization tracker. He is the founding steward of the IP Committee of the Psychedelic Bar Association, where he is also on the Board of Directors, and is a member of Chacruna's Council for the Protection of Sacred Plants.  Graham was raised in Oakland, CA, and currently lives in San Francisco. Highlights: Examining the unique patent process for the Stamets Stack microdosing protocol. How to enforce patents on illegal substances like psilocybin. Unpacking COMPASS Pathways' psilocybin polymorph patent. The pros & cons of psychedelic patents. How psychedelic patents could hinder therapeutic expansion. Graham's motivation to enter the psychedelic patents space. Key Links: Calyx Law Graham on Twitter Psychedelic Alpha Psilocybin Patent Tracker (blog) Microdosing Psilocybin Mushrooms with the Stamets Stack (psychedelic research) New Microdosing Study Investigates “Stamets Stack” (psychedelic research) Oregon's Psychedelic Path: What Coaches and Consumers Need to Know Episode Sponsors: Numinus Sayulita Wellness

In this episode of Psychedelics Weekly, Joe calls in from Los Angeles to cover the week's news with David.  They review:  -Dr. Julie Holland's recent appearance on the The Cannabis Investing Podcast, where she discussed the concept of cannabis being a psychedelic; -Vancouver Island University in British Columbia, Canada, planning to establish a Psychedelic Research Centre, with a focus on the historical and ethical context of psychedelic substances, using a "two eyed seeing" approach that combines Western-style science with Indigenous perspectives; -A group of investors creating a Real Estate Investment Trust (REIT) to purchase real estate for the purposes of psychedelic therapy, which, if used as the collaborative model we imagine it could be, could solve a lot of problems; -Diplo completing the Los Angeles Marathon in 3 hours and 35 minutes while under a reported 4-5 drops of LSD, and the dismissive spin mainstream media added to the story;  and a Rolling Stone article focusing on (and somewhat oversimplifying) the conflicts between the medicalization and decriminalization/legalization camps (can we just do both?). The articles of course lead to much larger discussions: how cannabis has helped David overcome OCD; the need for more transparency and a review system based on abusive behavior in the psychedelic space; the idea of collectivization in therapy models; why we need to agree on ethical foundations; and our general misunderstanding of IP and IP law: was all the criticism of Compass Pathways unwarranted? www.psychedelicstoday.com  

The Science Behind The Psychedelics Boom There's been an explosion of new research into therapeutic uses for psychedelics. This includes drugs like psilocybin, the hallucinogenic chemical found in “magic mushrooms,” and ketamine—which was originally used as an anesthetic, and later became a popular party drug also known as “special K.” Esketamine, a form of ketamine, was approved by the FDA in 2019 for use in treatment resistant depression. And just last month Colorado residents voted to legalize medicinal use of psilocybin. Following on the heels of Oregon's legalization in 2020, which is now in the process of being implemented. A recent study published in the New England Journal of Medicine showed promising results in using psilocybin to help patients with treatment-resistant depression. About a third of those who received the highest dose were in remission 3 weeks later. This was the largest look at psilocybin's effect on depression to date, involving 233 participants across ten countries in Europe. Ira talks with Dr. Steve Levine, senior vice president of patient access and medical affairs at COMPASS Pathways, the company that funded the study. Later, Ira takes a closer look into the latest psychedelic research and takes listener calls with Dr. Gerard Sanacora, professor of psychiatry and director of the Yale Depression Research Program at the Yale School of Medicine, and Dr. Alissa Bazinet, Clinical Psychologist, Co-Founder and Director of Research and Development at the Sequoia Center, and Associate Director of the Social Neuroscience and Psychotherapy Lab at Oregon Health and Science University.     How Will AI Image Generators Affect Artists? Back in August, controversy erupted around the winning submission of the Colorado State Fair's art content. The winning painting wasn't made by a human, but by an artificial intelligence app called Midjourney, which takes text prompts and turns them into striking imagery, with the help of a neural network and an enormous database of images. AI-based text-to-image generators have been around for years, but their outputs were rudimentary and rough. The State Fair work showed this technology had taken a giant leap forward in its sophistication. Realistic, near-instant image generation was suddenly here—and reactions were just as potent as their creations. Tech enthusiasts lauded the achievement, while artists were largely concerned and critical. If anyone could make a painting in just a few seconds, why would someone need to commission an artist to produce an illustration, or even bother spending years learning art at all? Read the rest on sciencefriday.com. Transcripts for each segment will be available the week after the show airs on sciencefriday.com.