Podcasts about lykos

We love to hear from our listeners. Send us a message. On this week's episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders. Rao also talks about atai's hub and spoke model for investing in other psychedelic companies, what MAPS/Lykos Therapeutics got wrong in the run-up to FDA's review of Lykos's MDMA candidate for PTSD, and whether psychedelic therapies need the "trip" to catalyze network disruption and neuroplasticity in the brain. This episode of the Business of Biotech is brought to you by Avantor. For more information, visit avantorsciences.comAccess this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

In this bonus episode of the Groupchat Wrestling Podcast, we sit down with Progress legend Kid Lykos ahead of this weekend's Super Strong Style 16 — and what a conversation it turned out to be!We've been trying to settle back into our usual weekly pace…But when a legend like Lykos wants to talk? You drop everything.Highlights include:Lykos reflects on past Super Strong Style tournaments and what it means to return as a champion.We preview this year's bracket and share bold predictions for who could go all the way.A deep dive into British wrestling's current momentum — including the rise of Leon Slater.Rapid-fire questions reveal Lykos' musical inspirations, fan run-ins, and a surprise shout for his dream match.Honest talk on social media's effect on wrestlers — and why support means more than ever right now.Whether you're Progress through and through or just want to hear smart, passionate wrestling talk — this is one for your queue.

Episode SummaryThe highly informed and deeply compassionate Amy Emerson joins Jef Szi and the How Humans Work Podcast for a remarkable conversation about the evolving landscape of psychedelics. With her extensive involvement and leadership in the Multidisciplinary Association of Psychedelic Studies (MAPS)* and their multi-year effort to get MDMA approved by FDA as a therapeutic medicine for PTSD. There are few better than Amy who can speak to the state of psychedelics for medical use in society. Not only does Amy share her honest appraisal about FDA drug approval process and members of congress on the Hill, she gives us the little known and fascinating history of MDMA. Some highlights are Sasha and Ann Shulgin's groundbreaking contributions, the reputational damage MDMA suffered in the 90's, the long-game efforts of Rick Doblin and others, the powerful way MDMA works on the brain, and the remarkable promise MDMA has shown to help people suffering with PTSD. Put together as a whole, Emerson offers us a destigmatized and inspiring view of MDMA beyond the common street descriptions of Ecstasy and Molly. From MDMA and the Medical Model, Amy then helps us see the many other use-cases for psychedelics that have a long and varied history. Building on issues of trauma and the importance of spiritually reconnecting with ourselves, we walk through the psychological benefits that can come with right-use of psychedelics.Finally, this conversation opens the visions of what future of psychedelic use in society through thoughtful contexts that track safety concerns and how, much like meditation, these ‘medicines' can have a place in our society like Buddhist and meditation practices have entered our culture. All in all, Breaking the Stigma is a podcast of significance, as it invites us to reconsider our biases around psychedelics at a time when our society is challenged by mental health matters like trauma and the pervasive disconnection from nature and spiritual renewal. ***** About: Amy Emerson is a highly respected leader in the field of psychedelic-assisted therapy. She was Lykos Therapeutics (formerly MAPS PBC) CEO for an important period in advancing MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) as a drug with the FDAShe earned a Bachelor of Science in Genetics and Cell Biology from Washington State University and spent the early career involved in roles at pharmaceutical companies, where she contributed to the development of therapies in immunology, oncology, and vaccines .​In 2003, she began volunteering with the Multidisciplinary Association for Psychedelic Studies (MAPS), assisting with clinical research monitoring. Her expertise was instrumental in establishing MAPS' clinical department and managing the MDMA Clinical Development Program. When MAPS founded its Public Benefit Corporation (MAPS PBC) in 2014 to develop and commercialize MDMA-assisted therapy, Emerson was appointed CEO .​Under her leadership, the organization, later rebranded as Lykos Therapeutics, completed multiple Phase 2 and Phase 3 clinical trials and raised approximately $150 million in funding. The company grew to over 120 employees, all working toward the goal of obtaining FDA approval for MDMA-assisted therapy for PTSD .​Amy resigned form her CEO role in September 2024. Currently she is a senior advisor to Lykos and an independent psychedelic research consultant, awaiting the next big adventure.*****Chapters00:00 Introduction and Setting the Stage02:40 The Evolution of Psychedelic Research06:10 Understanding Stigma and Its Origins10:54 MDMA: From Therapy to Recreation16:33 Therapeutic Applications of MDMA20:28 Navigating the FDA and Drug Development24:45 Challenges

«Νεάντερταλ», είναι ο τίτλος της νέας παράστασης του Ελληνοαυστραλού ηθοποιού και σκηνοθέτη Άλεξ Λύκου (Alex Lykos), που εξερευνά ένα εξαιρετικά σημαντικό κοινωνικό θέμα και ανεβαίνει τις αμέσως προσεχείς ημέρες στο Factory Theatre, στο προάστειο Marrickville του Σύδνεϋ.

Myself & Daniel discuss the upcoming TGW Mayhem Show ft Supersonic Sammy Blue Vs Billy O'Keeffe Vs Gung Hooooooo Muttley Vs Sean Only Big T Vs Ian Skinner kid Lykos 2 Vs Jet Martial Alexiss Falcon Vs Melissa Fierce Riley Nova Vs Vusyk NashBoat Vs NRG Brady Phillips Vs Rhio who do we think will win which matches stand out to us if you can't be in York watch on Triller

Detta avsnittet är i betalt samarbete med Qliro. I dagens avsnitt får vi en exklusiv inblick i entreprenörsresan med Rickard Lyko, grundare och vd för Lyko. Det som en gång var en liten frisörsalong i Dala-Järna har förvandlats till ett miljardbolag som förändrat skönhetsbranschen – men vägen dit har varit allt annat än spikrak. Rickard delar med sig av de avgörande besluten, de ekonomiska utmaningarna och de riskfyllda satsningarna som förde Lyko från nära konkurs till framgång. Vi dyker djupt in i Lykos marknadsföringsstrategier och avslöjar hur företaget kombinerat fysiska butiker med digital innovation för att skapa en lojal kundbas. Dessutom pratar vi om branschens virala produkter – varför exploderade intresset för snigelserum, och vad blir nästa stora trend?Vi får även ta del av Rickards personliga reflektioner om ledarskap, innovation och framtidsvisioner för Lyko. Från att ha lärt sig vikten av att vara känslomässigt öppen till att driva på för global expansion inom skönhetsbranschen. Missa inte detta avsnitt som inspirerar dig att gå från dröm till verklighet – och att våga satsa allt på vägen mot framgång.Följ Rickard Lyko här.Läs mer om Lyko här.Läs mer om Qliro här. Följ Qliro på LinkedIn.Ta del av Framgångsakademins kurser.Beställ "Mitt Framgångsår".Följ Alexander Pärleros på Instagram.Följ Alexander Pärleros på Tiktok.Bästa tipsen från avsnittet i Nyhetsbrevet.I samarbete med Convendum. Hosted on Acast. See acast.com/privacy for more information.

Detta avsnittet är i betalt samarbete med Qliro. I dagens avsnitt får vi en exklusiv inblick i entreprenörsresan med Rickard Lyko, grundare och vd för Lyko. Det som en gång var en liten frisörsalong i Dala-Järna har förvandlats till ett miljardbolag som förändrat skönhetsbranschen – men vägen dit har varit allt annat än spikrak. Rickard delar med sig av de avgörande besluten, de ekonomiska utmaningarna och de riskfyllda satsningarna som förde Lyko från nära konkurs till framgång. Vi dyker djupt in i Lykos marknadsföringsstrategier och avslöjar hur företaget kombinerat fysiska butiker med digital innovation för att skapa en lojal kundbas. Dessutom pratar vi om branschens virala produkter – varför exploderade intresset för snigelserum, och vad blir nästa stora trend?Vi får även ta del av Rickards personliga reflektioner om ledarskap, innovation och framtidsvisioner för Lyko. Från att ha lärt sig vikten av att vara känslomässigt öppen till att driva på för global expansion inom skönhetsbranschen. Missa inte detta avsnitt som inspirerar dig att gå från dröm till verklighet – och att våga satsa allt på vägen mot framgång.Följ Rickard Lyko här.Läs mer om Lyko här.Läs mer om Qliro här. Följ Qliro på LinkedIn.Ta del av Framgångsakademins kurser.Beställ "Mitt Framgångsår".Följ Alexander Pärleros på Instagram.Följ Alexander Pärleros på Tiktok.Bästa tipsen från avsnittet i Nyhetsbrevet.I samarbete med Convendum. Hosted on Acast. See acast.com/privacy for more information.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eli Lilly projects a revenue miss for 2024 due to lower-than-anticipated sales of glp-1 blockbusters Mounjaro and Zepbound, causing their shares to drop by as much as 8%. Despite pressure to make a deal, Biogen executives refuse to do so out of desperation. The JPM25 conference featured presentations from Roche, Amgen, Merck, Lilly, and Biogen detailing their growth strategies. Keros fully terminates a mid-stage study on pulmonary arterial hypertension, potentially facing challenges ahead. AGC Biologics offers scale-down data for gene of interest candidates to accelerate timelines. Other news includes questions about accelerated approval for Biogen and Sarepta drugs, lessons learned from Neuropsych's stumbles, and increased drug prices by pharmacy benefit managers. Additionally, Lykos loses board directors after an FDA rejection, while biopharma deals start flowing at JPM25.Biogen executives, despite investor and analyst pressure, are not desperate to make a deal at JPM25. The biopharma industry saw a flood of deals at the event, with companies like Eli Lilly, GSK, and Gilead announcing billion-dollar deals. Seaport is learning from Neuropsych's mistakes amidst renewed interest in the field. The top VC raises in biotech for 2024 were highlighted, showing a significant increase in funding for the industry. J&J made a major neuro play with a $14.6 billion buyout, while Biogen submitted an offer to buy partner Sage. Overall, the industry sentiment has been reinvigorated by the flurry of deals at JPM25.

Endlich sind die Argonauten im Schwarzen Meer angekommen, aber die Reise birgt trotz günstiger Winde auch weiterhin Gefahren. Zwei Argonauten werden sterben, andere werden neu dazukommen. Sie treffen auf unbekannte Völker und eigenartige Vögel mit Eisenfedern als Schusswaffen... Es sind die Stymphalischen Vögel, die Herakles einst vom Stymphalos-See verscheucht hat. Jetzt müssen die Argonauten es ihm nachtun und treffen kurz darauf auf Jasons Cousins 2. Grades: die Söhne des Phrixos, die in ihnen noch nützlich sein werden. Figuren: Jason, Tiphys, Athene, Pelias, Aietes, Apollon, Orpheus, Phineus, Pollux, Lykos, Daskylos, Idmon, Peleus, Idas, Ankaios, Erginos, Nauplios, Mopsos, Sthenelos, Herakles, Persephone, Sinope, Amphidamas, Oileus, Klytios, Erybotes, Chalkiope, Phrixos, Helle. Orte: Schwarzes Meer, Kolchis, Aia, Iolkos, Dodona, Thermodon, Acheron, Sesamon, Assyrien, Amazonenland, Chalyberland, Tibarenisches Land, Mossynoikerland. Sonstige: Argo (Schiff), goldenes Vlies, Symplegaden, stymphalische Vögel, Lyra, Unterwelt, Gürtel der Amazonenkönigin, Platanen, Eiche von Dodona. STEADY https://steadyhq.com/de/chaoskinder/about WERBEFREIER FEED https://open.spotify.com/show/5yF7oCMeJ9VuXNOKGI91ZS?si=6c90144399804043 PAYPAL https://www.paypal.com/donate/?hosted_button_id=VB2QKC88H9NYJ LITERATUR https://chaoskinderpodcast.wordpress.com/2022/06/27/quellen-und-literatur-auswahl/ MUSIK https://youtu.be/zfnRMIFHHrE WEBSITE www.chaoskinderpodcast.wordpress.com MAIL chaoskinderkontakt@gmail.com INSTA https://www.instagram.com/chaos.kinder/ FRANZÖSISCH "Le Chaos et ses enfants" https://podcasters.spotify.com/pod/show/lechaosetsesenfants

In this episode, Kyle interviews Geoff Bathje, Ph.D.: licensed psychologist, researcher, former Full Professor, and co-founder of Sana Healing Collective, a Chicago-based non-profit focusing on ketamine-assisted therapy and psychedelic integration. He talks about what he feels is one of the largest factors in our mental health crisis: the individualistic and neoliberal lens Western culture has placed on mental health and how it neglects the massive systemic and relational factors that are affecting us all. He digs into how we got so alienated and how psychedelics and non-ordinary states of consciousness can not only help us think critically and solve problems, but also move us out of this individualistic framework of healing and more into a collective one. How do we use psychedelics to fix our relationships and find our community? He discusses: The challenge of knowing when to work for relationships and when to just end them, especially in the afterglow of a big experience Group ketamine experience vs. individual, how groups can help facilitators find patterns, and how ketamine works with somatic therapy His paper, “Psychedelic integration: An analysis of the concept and its practice” and his visual model of integration showing the different domains of our personal experience What he thinks will happen next in drug development: Will therapy be left out after Lykos' failure with MDMA? The importance of moving beyond aggressive criticism and moving into world building and more!  For links, head to the show notes page. 

In this episode, David interviews Floris Wolswijk: senior project manager at Delphi; co-founder of FLO coaching; and founder of Blossom, an online informational hub collecting psychedelic courses, trials, companies, and over 2000 categorized research articles. When Wolswijk began Blossom, he was barely able to fill a weekly newsletter, and now he's adding a new study nearly every day, perfectly illustrating the exponential growth in psychedelic research. He talks about why so much research is happening (and why more isn't), the trends he's seen, the benefit in research changing people's minds, and what he hopes for in the future. What can the research community learn from existing real world evidence, and how can retreat centers and underground communities contribute? He also discusses: What culture is like in the Netherlands, where psilocybin truffles are legal Drug development and the possibilities of adjusting existing molecules What we can learn from the Lykos and FDA situation The economics of psychedelics and how insurance will likely be the next big conversation His work with FLO coaching, and how coaching, acceptance and commitment therapy, and psilocybin can work together and more!  For links, head to the show notes page. 

In this episode of the Psychedelic Medicine Podcast, Eric Sienknecht, PsyD joins to discuss the roles of music in psychedelic sessions. Dr. Sienknecht is a licensed clinical psychologist and co-founder and lead trainer at Polaris Insight Center, a ketamine-assisted psychotherapy clinic and training center. He has worked as sub-investigator and study therapist on the Lykos-sponsored MDMA-AT clinical trials for PTSD and currently is also a supervisor and educator in MDMA-AT for various clinical trial sites. Dr. Sienknecht has a deep interest in the role and use of music in ketamine and MDMA sessions and specializes in curating playlists for psychedelic experiences. In this conversation, Dr. Sienknecht discusses how he first realized the importance of music in psychedelic experiences. He shares insights on how different genres and moods of music may be better suited to certain phases of the psychedelic experience and how he works individually with clients to better tailor a session playlist to their personal taste. Dr. Sienknecht even discusses how to strategically include shadow elements in a playlist to facilitate a client going deeper in their journey. In closing, he emphasizes how the intersection of psychedelic experiences and music remains understudied with only a few book chapters and articles dealing directly with the topic, so there is much yet to learn and explore in this exciting niche.    In this episode you'll hear: What is universal vs what is individual when it comes to music and psychedelics Why Dr. Sienknecht avoids music with lyrics in a participant's native language for psychedelic sessions The research on different genres of music for psychedelic journeys Balancing planning music in advance and adapting to the specific pace and mood of the client's experience Utilizing nature sounds alongside or within music during psychedelic sessions Binaural beats and brainwaves   Quotes: “There's generally better tracks to use for the opening phase of a [psychedelic] journey, for the peak phase of a journey [etc], and there's been some research into that as well.” [6:05] “Taste is so subjective… Knowing your client and talking with them beforehand about their taste and letting that information really inform how you create the playlist is really important.” [27:02] “One of the benefits of doing psychedelic therapy is that you can surrender control over elements of set and setting—not that those aren't negotiable and ongoingly negotiable, as they should be—but there's something about [the fact that the therapist] has got the music taken care of, the room set up, everything is in its right place. All I have to do is fast from food for a few hours, have my intention, and step into the journey—and that can help someone to really just trust and surrender more into the experience.” [30:20]   Links: Integral Psychedelic Therapy edited by Jason A. Butler, Genesee Herzberg, and Richard Louis Miller Dr. Sienknecht on LinkedIn Polaris Insight Center on LinkedIn Polaris Insight Center website Music for Ketamine-Assisted Psychotherapy Sessions training with Dr. Sienknecht at Polaris Insight Center Previous episodes: Psychedelics and Nature: The Symbiotic Relationship with Dr. Sam Gandy Psychedelic Medicine Association Porangui

Ospite della 131° puntata di Illuminismo Psichedelico è Rick Doblin, fondatore e presidente della Multidisciplinary Association for Psychedelic Studies (MAPS) ed ex membro del consiglio di amministrazione di Lykos Therapeutics. Insieme a Doblin abbiamo parlato della sua scoperta e del suo rapporto con l'MDMA, di come questo abbia ispirato la nascita di MAPS e le ricerche per consentire un uso terapeutico della sostanza, ma anche di come poi le cose siano andate male, a causa della concorrenza di altre entità che chiedevano fondi per ricerche sugli psichedelici MAPS è stata costretta a generare una costola "for profit", Lykos, che ben presto è diventata un "lupo tra i lupi", e Doblin ha deciso di lasciarla, mostrandosi molto critico con come la nuova entità ha scelto di comunicare ma anche di difendere i risultati della fase 3 dei trial sull'MDMA, bocciati nella scorsa estate dalla FDA. 

In this episode, Joe interviews Rick Doblin, Ph.D.: founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), and former board member at Lykos Therapeutics, MAPS' public benefit subsidiary. Doblin tells his side of the story: that the FDA's concerns with double blinding not working had been fully addressed ahead of time, that they had negotiated agreements that were no longer agreed to when new FDA employees came on board, that there was a lot of confusion from going back and forth with the FDA on how Phase 3 studies should be designed, and more. He believes that Lykos made a massive mistake in assuming that provable science was more important than public opinion, and that ignoring critics who were saying whatever they wanted caused them to lose control of the narrative – which clearly influenced the advisory committee. While Lykos figures out their next steps with the FDA, MAPS is focusing their attention on what they feel is most important in light of this ruling: better public education and drug policy. He talks about: How there's a bias at the FDA to be harsh: Does automatically saying no just make it look like you're being rigorous? The work of the Dutch government in researching MDMA, and Lykos' odd decision to not highlight any of it Massachusetts' Legalization and Regulation of Psychedelic Substances initiative, and the huge opportunity for progress at the local level Why federal agents at Burning Man work so hard to give tickets to attendees for smoking cannabis Why sharing stories of your positive experiences with psychedelics is so important and more!  MAPS has announced that 2025's Psychedelic Science conference will be in Denver, June 16-20, and will have experiential opportunities before and after.  For links, head to the show notes page. 

Cecilia Kroon, Marknadschef på Lyko, berättar bland mycket annat om: - Hur det första halvåret på Lyko har varit - Lykos plan för att fortsätta växa - Rollen som marknadschef på Lyko och hur marknadsavdelningen är uppbyggd - Varför Lyko valt att arbeta med en mediebyrå för medieköpen “offline” men valt att äga all onlineannonsering in-house - Dokumentet “Excel from Hell” och hur Lyko håller ihop alla kampanjer - Hur marknadsföringen kan skilja sig åt mellan olika marknader och hur man får ihop helheten - Attributions-utmaningar och att utvärdera kampanjer och marknadsföringen - Varför det är viktigt att sätta en vinnande tonalitet - Hur Lyko använder verktyget Winningtemp för att skapa välmående och framgångsrika team - Kulturen på ägarledda bolag - Lykos AI-assistent - Lykos community “Lyko Social” och kraften i användargenererat innehåll - Vikten av att avsätta tid för kompetensutveckling hos alla i marknadsteamet Varmt välkommen att lyssna! Programledare: Martin Matiesen och Sandra Modée Producent: Peder Groth, Dogwood AB Länk till poddens hemsida: https://sverigesmarknadschefer.se/

In this episode, Joe interviews Ingmar Gorman, Ph.D.: clinical psychologist and co-founder and CEO of Fluence, a psychedelic education company. Gorman served as a co-principal investigator and study therapist on MAPS' Phase II and III clinical trials for MDMA-assisted psychotherapy for PTSD, and works with drug sponsors: training, developing the components for clinical trials, and designing therapy manuals. With his insider's perspective, he discusses the reasons why he believes the FDA rejected MDMA-assisted psychotherapy for PTSD: from ICER's 2.1 section of the report giving legitimacy to allegations they don't have the authority to research, to Lykos not being able to defend some accusations due to confidentiality, to the damage caused over time (which likely influenced the decision) from attacks against Lykos from dissenters. He discusses: How, despite abuse claims, the main allegations in the report were actually about the mishandling of data or influence of investigators on participants The complications of needing to follow study frameworks: Should your adverse experience be in the report if it happened outside the study window? How easily opposition can attack and demonize a faceless company, while forgetting the humanity of the people behind it Inner healing intelligence and the proposition that people have been indoctrinated into this concept by MAPS The need for journalists to research more and not just jump on a narrative and more! For links, head to the show notes page. 

Cybin CEO Doug Drysdale talks to Jason Najum about transforming treatment of mental health disorders with psychedelics (0:45). CYB003, Phase 2 results for depression, moving into Phase 3 (3:00). How deuterated psilocin differentiates Cybin from competiton (10:00). IP and patents - critical to ROI (12:45). Esketamine and is JNJ's Spravato blazing a trail for psychedelics? (14:15) FDA challenges and Lykos lessons (21:20). Strong balance sheet will get it through Phase 3 data (25:50) Stock consolidation and attracting new buyers (30:35).Episode transcriptsShow Notes:Imran Khan On Psychedelics - More We Don't Know Than We DoPsychedelic Stocks: Focus On Their CashFDA's MDMA Decision A Setback, But Long-Term Outlook For Psychedelic Stocks UnchangedDe-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

Welcome to The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.Last week on the podcast, I spoke with Dr. Carlene MacMillan, psychiatrist and Chief Medical Officer of Osmind, about the FDA's rejection of MDMA Assisted Therapy. That conversation focused on some of the problems with the application, including potentially missing data, inaccurate or unreported adverse events, and the general uncertainty that both the Advisory Committee and FDA itself had with the work Lykos submitted.Today's conversation addresses the matter from another perspective, namely the inadequacy of the current regulatory regime for evaluating treatments that challenge the current epistemological paradigm and come from “outsider” organizations.To make sense of this, I asked Nick Gillespie, Editor at Large of Reason Magazine, to come on the podcast to discuss the matter. To say that Nick is critical of the FDA would be an understatement.His position is that the latent mission of the FDA and other regulatory agencies is to maintain the existing power structures and commercial interests of the organizations they regulate rather than to protect public health, ensure public trust, or facilitate the availability of new treatments.His views challenge mainstream narratives of both the right and the left, which makes him the perfect guest as we delve into the complexities of drug regulation, the FDA's role in approving psychedelic therapies, and the broader implications for personal autonomy in today's world.In this episode, we explore:* The challenges of navigating the FDA's regulatory process for novel therapies like MDMA-assisted psychotherapy.* The increasingly confusing political and ideological landscape * Outdated and ossified regulatory institutions* The prospect of individual states taking over regulatory responsibilities from the federal government* The cultural and political dynamics that shape public opinion on psychedelics and other controlled substances.* The evolving landscape of personal freedom in the context of healthcare and drug use.* And much more.And now, I bring you my conversation with Nick Gillespie.Listen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTubeTheme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com

The FDA rejected MDMA-assisted therapy for PTSD last week. A major setback for psychedelic medicine, but certainly not a complete surprise to insiders and the team at Lykos Therapeutics after the decision in June by the FDA's Psychopharmacologic Drugs Advisory Committee.The FDA asked Lykos to complete more studies, so now we will wait to see how Lykos works hand-in-hand with the FDA to make sure the trial design fits their criteria.Lykos, and parent company MAPS, have been researching MDMA-AT for PTSD and working to get MDMA-AT approved for nearly two decades.This is a setback, but definitely not the end for these breakthrough therapies.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.J&J has acquired heart failure implant maker V-Wave for up to $1.7 billion, while Medtronic reiterates its unchanged diabetes strategy despite a partnership with Abbott. Histosonics secured $102 million for a noninvasive tumor treatment using sound waves, and Edwards acquired Genesis' TAVR technology. The FDA approved NowDiagnostics' at-home syphilis test, offering results in 15 minutes with a drop of blood. The biotech industry remains strong in 2024, with startups thriving and technology advancements. Small biopharma and CROs are adopting multiple trial technologies, as per a recent survey.23andMe, known for consumer genetic testing, focuses on therapeutics development despite financial struggles and data breach lawsuits. Their lead candidate targets a new cancer treatment pathway using checkpoint inhibitors. Lilly's diabetes drug tirzepatide shows promise in reducing type 2 diabetes risk, while J&J's Rybrevant and Lazcluze combo is FDA-approved for lung cancer. Avidity and Kymera raised funds, Walgreens partnered with BARDA, and Merck licensed an antibody drug conjugate. Humana settles Medicare Part D fraud allegations, Steward hospitals in Massachusetts must sell five facilities, and McLaren Health Care faces another ransomware attack.Eli Lilly's tirzepatide demonstrates a 94% risk reduction for type 2 diabetes in overweight adults, and J&J's Rybrevant combo is the first chemo-free treatment for non-small cell lung cancer. Walgreens and BARDA collaborate to boost decentralized clinical trials, while three drugs are projected to drive drug price negotiation savings in 2026. Quality Assurance and Regulatory Affairs roles are crucial for market access, AbbVie and Genmab expand Tepkinly's European label, and biopharma companies like Lykos, Galera, and Grail announce staff reductions. AstraZeneca receives FDA approval for Imfinzi's perioperative use.Lykos restructures with significant staff cuts post-FDA rejection of their therapy, Acelyrin shifts focus to thyroid eye disease treatment after layoffs. Biotech IPO sizes are increasing despite slow IPO rates, Lilly opens an R&D hub in Boston, Ovid and Lexicon downsize staff. Stay informed with Biopharma Dive's comprehensive coverage of biotech and pharma industry news.

On Aug 9th the FDA rejected the new drug application by Lykos (formerly MAPS PBC) for MDMA-assisted therapy for PTSD. This is disappointing news for those of us who were excited about the promising study results and eager to add MDMA-assisted therapy to the menu of treatment options for those suffering with PTSD. We discuss what appears to have influenced the FDA's decision, the possible path forward for Lykos, how this ruling affects other companies trying to bring different psychedelic medicines to market, and much more.Learn more about our podcast at https://numinus.com/podcast/Learn more about psychedelic therapy training opportunities at https://numinus.com/training/Learn more about our clinical trials at https://www.numinus.com/clinical-trials Learn more about Numinus at https://numinus.com/Email us at ptfpodcast@numinus.com Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.On August 19, 2024, the FDA approved the first at-home syphilis test by NowDiagnostics, providing quick results with just a drop of blood. Dupont acquired Donatelle Plastics for $313 million, while Boston Scientific resubmitted its merger filing for Silk Road Medical. Edwards invested in Genesis Medtech and Biden pledged $150 million for medical technology to enhance cancer surgery. The biotech industry is active, with companies gearing up for the DSCSA deadline and utilizing multiple trial technologies. In the biopharma industry, Bristol Myers' schizophrenia drug is nearing approval, a partial hold was lifted on a Biontech-partnered ADC study, Novo Nordisk plans to build a new plant, and Medicare drug price cuts are impacting pharma profits. Patient-centric commercialization strategies are on the rise, along with concerns about Medicare price cuts affecting drug research and patent protection measures.Bristol Myers Squibb's KarXT faces a PDUFA date for potential approval as a new schizophrenia treatment. AbbVie's Emraclidine also shows promise as a gut-friendly option for schizophrenia patients. Market strategies beyond FDA approval are being explored to ensure successful drug launch and adoption in the competitive landscape.The FDA has cleared Biontech-Medilink's Phase I ADC cancer trial after a partial hold, while Liquidia missed full approval for a pulmonary hypertension drug. Bavarian Nordic is ramping up vaccine production in response to a global health emergency. Developers remain optimistic about psychedelic therapies despite setbacks like Lykos' rejection. Other updates include advancements in various therapeutic spaces and industry shifts such as layoffs.Texas hospitals secured a victory in a lawsuit on low-income payment formulas. Employer healthcare costs are expected to rise due to inflation and specialty drugs. Healthcare bankruptcies have slowed down but financial challenges persist. Payers are leveraging digital technology to improve outcomes and prepare for regulatory changes like the DSCSA deadline. Healthcare organizations are focusing on patient-centric care, combating burnout, and adapting to trends like telehealth and value-based care.In conclusion, the Pharma and Biotech industry is evolving rapidly with advancements in technology, regulatory changes, and shifting market dynamics shaping its future trajectory. Stay tuned for more updates on the latest developments in this dynamic sector.

This episode of the Drug Report podcast unpacks the FDA's recent decision to reject Lykos' psilocybin product intended for treating PTSD, a move that has sparked fierce debate. We also delve into the significant fallout for Lykos, from massive layoffs and leadership upheavals to the company's uncertain future. Plus, the tragic case of Matthew Perry is intertwined with broader concerns about the safety and efficacy of psychedelic treatments.Follow the work of SAM and FDPS below:https://learnaboutsam.org/https://gooddrugpolicy.org/https://thedrugreport.org/On X: https://twitter.com/learnaboutsamhttps://twitter.com/GoodDrugPolicyhttps://twitter.com/KevinSabethttps://twitter.com/LukeNiforatosOn Facebook: https://www.facebook.com/learnaboutsam

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:   The good — FDA approves Ascendis hypoparathyroidism drug  The bad — FDA rejects Lykos MDMA PTSD drug  The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug 

Andrew has been closely following the efforts of organizations like MAPS (Multidisciplinary Association for Psychedelic Studies) and Lykos Therapeutics as they pioneer the use of MDMA-assisted therapy for treating PTSD. Recently, the FDA delivered a surprising and disappointing decision, declining to approve MDMA-assisted therapy despite promising clinical data and asking the company to conduct an additional Phase 3 Study. This ruling has sent shockwaves through the field of psychedelic medicine, especially for those who had high hopes that MDMA would become the first federally regulated psychedelic treatment. In our conversation today, Andrew will share his insights on the FDA's decision, the implications for Lykos Therapeutics, and what this means for the future of psychedelic therapies. We'll delve into the challenges faced by Lykos, including the FDA's request for an additional clinical trial, which could add years and significant costs to the approval process. We'll also explore the broader context of this decision—how it affects the momentum of the psychedelic medicine movement, the reaction from supporters and critics alike, and the potential shifts in strategy as the industry continues to navigate regulatory hurdles. For those interested in the intersection of health, science, and business, this discussion promises to be both timely and insightful. So, without further ado, let's dive into our conversation with Andrew Jacobs. Link to Andrew's New York Times bio: https://www.nytimes.com/by/andrew-jacobs Social Media: X: @AndrewJacobsNYT Other Links/Mentions: F.D.A. Declines to Approve MDMA Therapy, Seeking More Study What Is MDMA Therapy and What Are Its Risks? A Psychedelics Reporter With a Changing Perspective Show Credits: This episode was hosted by Lewis Goldberg and Anne Donohoe of KCSA Strategic Communications. Special thanks to our Program Director, Shea Gunther. You can learn more about how KCSA can help your cannabis and psychedelic companies by visiting www.kcsa.com or emailing greenrush@kcsa.com. You can also connect with us via our social channels: X: @KCSAPodcastLabs Instagram: @KCSAPodcastLabs LinkedIn: https://www.linkedin.com/company/kcsapodcastlabs/

In one of the year's most highly anticipated decisions, the FDA rejected Lykos Therapeutics' MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Reaction from Lykos was swift, with the company stating its intention to “ask for reconsideration of the decision.”   Meanwhile, against the backdrop of the CDC's recent RSV guidelines, Pfizer scored a big Phase III win for its shot in immunocompromised adults. Separately, Merck halted a Phase III trial of its Keytruda, anti-TIGIT, chemo combo in small cell lung cancer but made a splash with the potential $1.3 billion acquisition of Curon's B cell depletion therapy. And AI-focused biotechs Recursion and Exscientia are merging to create a new company that will take Recursion's name. Plus, as we reflect on Q2 earnings, it's becoming clear that Eli Lilly is catching up to Novo Nordisk in the weight loss sphere, while others faced challenges in the vaccine space and the continued COVID cliff. Finally, BioSpace highlights five obesity data readouts to watch in the second half of 2024.

In this episode, Chris Koddermann interviews two members of the Center for the Neuroscience of Psychedelics at Mass General Hospital: founding director, author, and co-founder of three drug development companies, Dr. Jerry Rosenbaum; and psychiatrist and associate director and director of cognitive neuroscience, Sharmin Ghaznavi, MD, Ph.D. Rosenbaum and Ghaznavi bonded over an interest in rumination, and wondered: How could the plasticity-inducing effects of psychedelics change these negative loops people find themselves in? How important is the ability to break out of those loops – and learn new patterns – when our concept of self is so central to who we are? Ghaznavi is studying the effects of psilocybin on rumination and scanning patients at multiple times throughout the process to track data we still don't really have: how psychedelic-induced neuroplasticity changes over time, and why. They discuss: How much of a role the default mode network takes in the therapeutic benefits of psychedelics: Is it overblown? Hyperscanning, which involves scanning two individuals at the same time, looking for potential concordance in signal and/or an increased alliance between the therapist and patient The Schultes Legacy Project and the work of Stephen Haggarty to explore the potential of largely unstudied psychoactive plants Critiques of the recent ruling on Lykos and MDMA-assisted therapy and the clash between the FDA and the advisory committee: Were they really on the same page? The false dichotomy of neuroscience vs. patient experience: Does the subjective experience actually increase plasticity and other measurable benefits? and more! For links, head to the show notes page.

Welcome to a special episode of The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.Today, we're dissecting the FDA's rejection of Lykos Therapeutics MDMA Assisted Therapy with Dr. Carlene MacMillan MD, a Harvard-trained psychiatrist and Chief Medical Officer at Osmind.In her role at Osmind, Dr. MacMillan has the unique experience of helping practices across the country adopt new treatment modalities like Ketamine, Spravato, and Transcranial Magnetic Stimulation. And through her work with professional societies like the American Psychiatric Association and the Clinical TMS Society, she has been involved in developing policies, treatment codes, and access to new interventional psychiatric treatments. This background and experience made her a great person to speak with about the FDA decision, the most pivotal development this nascent field has seen.In this special dispatch, we dive deep into the potential rationale and aftermath of the FDA's decision, as well as the implications for the future of psychedelic therapies, research, and commercialization. In this conversation, we discuss:* The allegations of research misconduct* The difficulty the FDA and Advisory Committee had with the therapeutic component of the trial* The complexities of psychiatric trial designs and the importance of reliable data.* The role of real-world evidence and post-marketing data in evaluating new treatments.* The challenges of integrating new therapies into mainstream healthcare.* The future of psychiatric treatments, including neuromodulation and other emerging therapies.* And much more.And now, I bring you my conversation with Dr. Carlene MacMillan.Listen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTube* Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com

Today, we are speaking with Dr. Selma Holden, MD, a physician-therapist and director of the Riverbird Clinic, an innovative group psychotherapy and Psychedelic-Assisted Therapy practice in Portland, Maine.Before starting Riverbird, Dr. Holden practiced family medicine in rural Maine and received research training through the Integrative Medicine Research Fellowship at Harvard Medical School.In this episode, we dive into the pivotal moment approaching for psychedelics: the FDA's decision on MDMA-assisted therapy expected this week.I wanted to bring Dr. Holden on because she has been trained in the MDMA Assisted Therapy protocol that Lykos submitted to the FDA for review and has been involved in psychedelic therapy and research for a long time.Dr. Holden provides invaluable insights into the intricacies of clinical trials, the challenges faced, and the potential impact of the FDA's decision on the future of psychedelic therapy.In this conversation, we discuss:* Dr. Holden's early experiences with psychedelics and their influence on her career* Her innovative approaches to integrating psychedelics into family medicine* The development and challenges of clinical trials for MDMA-assisted psychotherapy* The anticipation and implications of the upcoming FDA decision on MDMA-assisted therapy* The development of the Riverbird Clinic and its unique group therapy models* The challenges and opportunities in the evolving field of psychedelic-assisted therapyListen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTubeTheme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com

This week, Kamala Harris selected Minnesota Governor Tim Walz as her running mate. In July, Harris' campaign netted a whopping $310 million—so where do pharmaceutical-connected contributions stand?   Meanwhile, Q2 earnings continue to roll in, and the picture isn't looking so bright for some companies particularly vaccine makers like BioNTech, Moderna and Pfizer, who have been hit hard by the COVID-19 cliff and new CDC guidelines around RSV vaccines.   The FDA has also been busy of late, approving the first engineered cell therapy for solid tumors in Adaptimmune's Tecelra. The regulator has another potential first on the docket this week in the form of Lykos Therapeutics' MDMA-assisted treatment for PTSD—but Lykos will need to overcome a decidedly negative advisory committee vote and concerns surrounding its Phase III trial design. If approved, it would be the first classic psychedelic therapy authorized in the U.S.

What if the very strategies intended to reduce harm from drug use are actually endangering the very people they aim to protect? This episode of the Drug Report promises to tackle the complexities and controversies surrounding research into harm reduction in drug policy. With significant federal funding now backing harm reduction research, we stress the critical importance of reputable science in shaping effective policies. Hear our nuanced critique on the growing influence of drug normalization in policy-making, through revealing case studies like the Greater Harlem Coalition's experience with pro-drug Yale researchers.But that's not all. We dive into the murky waters of ethical concerns surrounding drug research, spotlighting the scandal involving Lykos (formerly MAPS) and its contentious clinical trials for psychedelic drugs. The Wall Street Journal's reports on unreported suicidal ideation among trial subjects raise alarming questions about participant safety and research ethics, echoing historical parallels with the tobacco industry. Finally, don't miss out on our exciting announcement about the TDR newsletter, brimming with insightful articles and a compelling editorial piece. Your feedback is invaluable to us, and we hope you find this episode as thought-provoking as we do.Follow the work of SAM and FDPS below:https://learnaboutsam.org/https://gooddrugpolicy.org/https://thedrugreport.org/On X: https://twitter.com/learnaboutsamhttps://twitter.com/GoodDrugPolicyhttps://twitter.com/KevinSabethttps://twitter.com/LukeNiforatosOn Facebook: https://www.facebook.com/learnaboutsam

Send us a Text Message.Novel Psychedelics drug developer Cybin's CEO Doug Drydale joins WTR's Tim Gerdman and Robert Sassoon to talk about the company's fast-track development into a late-stage clinical development company, and what differentiates Cybin from other drug developers in the psychedelics space. Drysdale discusses Cybin's plans and priorities for its development pipeline going forward and talks about the company's extensive IP real estate. He also shares his perspectives on the regulatory uncertainty currently surrounding Lykos's MDMA-AT and how Cybin is dealing with it to its benefit 

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

For years, psychiatrists have been researching new methods to help people with treatment-resistant mental illness. These include severe cases of depression, post-traumatic stress disorder, and other debilitating diagnoses. One type of drug has seen some positive results in clinical trials: psychedelics like psilocybin, MDMA, ketamine, and LSD. In professional medical settings, they're used as a part of a multifaceted approach to mental health treatment, including supervised therapy sessions while a patient is on a drug. Recently the pharmaceutical manufacturer Lykos petitioned the FDA to approve the psychedelic MDMA as a part of caring for treatment-resistant PTSD. Earlier this month, an advisory committee to the FDA released their vote of rejecting to approve the drug.  Now it's up to the FDA to make the final call, but the odds are not in the favor of Lykos and many psychiatrists and patients who've seen positive outcomes as a result of these MDMA-assisted trials. Psychiatrist and entrepreneur Dave Rabin is one of the doctors pushing to approve psychedelic-assisted therapy.  On this week's episode of Well, Now we ask him about the results of his trials using psychedelics in therapy as well as what he thinks the future holds for this field as we wait for the FDA's final verdict. If you liked this episode, check out: “As Little Regulation As Guns”: How Social Media Hurts Youth Mental Health Well, Now is hosted by Dr. Kavita Patel and registered dietitian nutritionist Maya Feller. Editing and podcast production by Vic Whitley-Berry, with support this week from Kristie Taiwo-Makanjuola. Editorial oversight from Alicia Montgomery, Vice President of Slate Audio. Send your comments and recommendations on what to cover to wellnow@slate.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

The biggest news of the last week was easily the expanded approval of Sarepta's Duchenne muscular dystrophy gene therapy, Elevidys. CBER Director Peter Marks again overruled FDA staff members and review teams to grant the therapy full approval and a broad label expansion despite its missing the primary endpoint in a Phase III confirmatory study. This approval has us thinking about other big FDA decisions to watch this year, first and foremost, Eli Lilly's anti-amyloid antibody donanemab. If given the green light, donanemab will be a direct competitor to Biogen and Eisai's Leqembi, also a disease-modifying anti-amyloid antibody. Beyond that, Verona Pharma is expecting a decision Wednesday on ensifentrine, which could be the first novel mechanism for chronic obstructive pulmonary disease in over a decade, and in August, the FDA is set to decide on Lykos' MDMA-assisted PTSD therapy, which an advisory committee voted against earlier this month. Then this week, Alnylam scored big with a Phase III win in transthyretin amyloidosis with cardiomyopathy (ATTR-CM). In what Alnylam CMO Pushkal Garg called “overwhelmingly positive data,” Amuvttra significantly lowered the risk of death and recurrent cardiovascular events in patients with ATTR-CM. Meanwhile, biopharma conference season continues with the American Diabetes Association's annual conference held this past weekend. Eli Lilly's blockbuster drug Zepbound “significantly improved” disease severity in patients with obesity and sleep apnea, and Altimmune racked up a Phase II victory for pemvidutide, which was effective at helping patients lose weight while retaining lean muscle.

In today's episode of the Psychedelic Therapy Frontiers podcast Dr. Steve Thayer and Dr. Reid Robison  talk about the recent FDA psychopharmacologic drugs advisory committee meeting that resulted in a majority vote against the approval of MDMA-assisted therapy for PTSD based on MAPS/Lykos study data. They discuss what the committee's concerns were, the Institute for Clinical and Economic Review's (ICER) criticisms of the studies, the challenges of conducting psychedelic clinical trials, functional unblinding, how research and rater bias affects study data, and much more.https://psychedelicalpha.com/news/exclusive-therapists-and-trialists-from-lykos-phase-3-mdma-assisted-therapy-studies-push-back-on-icers-critical-draft-reportLearn more about our podcast at https://numinus.com/podcast/Learn more about psychedelic therapy training opportunities at https://numinus.com/training/Learn more about our clinical trials at https://www.numinus.com/clinical-trials Learn more about Numinus at https://numinus.com/Email us at ptfpodcast@numinus.com Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/

Ospite della 113° puntata di Illuminismo psichedelico - andata in scena al Cikoloco di Firenze - è stata la dottoressa Caterina Bartoli, nota per il suo progetto di divulgazione Studio Aegle. Durante la puntata si è parlato del rapporto tra case farmaceutiche e farmaci (o potenziali farmaci) psichedelici, partendo dal discusso caso del parere negativo fornito da una commissione indipendente circa l'adozione della terapia assistita con MDMA come cura del disturbo post traumatico da stress (PTSD), ideata e proposta da MAPS (ora Lykos). Il parere negativo non compromette l'eventuale adozione del trattamento, che sarà decisa l'11 agosto di quest'anno, ma è un segnale fortemente negativo in tal senso. 

PROGRESS Men's World Champion Kid Lykos talks the end of his wrestling career - and his incredible comeback story! Lykos also chooses three wrestling matches to watch whilst stranded on a desert ilsnad Hosted on Acast. See acast.com/privacy for more information.

Vi kör live från Qliros e-com event på Moderna Museet i Stockholm och pratar med några av branschens hetaste profiler om high performance inom e-commerce. På scen är inga mindre än Erika Lyko från LYKO, Sofia Lind Andersson från Malina & Soft Goat, Kousha Torabi på Ninepine, Andreas Koschnike på ACCEXE, Mårten Åkeson från Proteinbolaget, Lisa Karlsson Bruzelius från NordicFeel Group, Christer Åberg från Zoo, Niklas Söderholm från Auctionet, Fredrik Norberg från CDON, & Joel Savilathi från Ingrid. 02:00 - Erika Lyko talar om Lykos resa och framtidsplaner. 19:45 - Första panelen med Sofia, Koushai, Andreas & Mårten “high-performance” diskuteras ur ett direkt-till-konsument-perspektiv. 43:30 - Kvällens andra panel med Lisa, Christer, Niklas, Fredrik & Joel talar om high-performance ur ett multibrand och marketplace perspektiv.Ta del av hela innehållet på Qliro.comhttps://bit.ly/3VvjZsl Följ Björn på LinkedInFölj Framtidens E-handel på LinkedInBesök vår hemsida, YouTube & InstagramBesök Qliro https://www.qliro.com/sv-se/foretag/ https://www.linkedin.com/company/3743067Tusen tack för att du lyssnar!Support till showen http://supporter.acast.com/framtidens-e-handel. Hosted on Acast. See acast.com/privacy for more information.

Noticias Económicas y Financieras Un gran anuncio de la OPEP+ el domingo ha estado resonando en el sector energético durante los últimos días. El grupo detalló una serie de recortes y extensiones de producción, dando a los participantes un calendario de reducción gradual más claro hasta finales de 2025. A pesar de la proclamación, los precios del petróleo han tenido problemas en las últimas sesiones, con el crudo Brent (CO1:COM) cayendo por debajo de los 80 dólares el barril durante el por primera vez este año y el WTI (CL1:COM) se acerca a los 70 dólares, muy lejos de la marca de 100 dólares a la que apunta la OPEP+ con su nueva hoja de ruta. Un panel de asesores de la FDA se negó a respaldar la solicitud de Lykos Therapeutics para comercializar la droga psicodélica MDMA, también conocida como éxtasis, como tratamiento para el trastorno de estrés postraumático. El panel votó 9 a 2 en contra del tratamiento cuando se le preguntó si los datos mostraban la efectividad de la MDMA, y 10 a 1 en contra cuando se le preguntó si los beneficios de la MDMA superaban sus riesgos. Lykos había propuesto tres sesiones de administración de MDMA junto con psicoterapia para un único tratamiento de cuatro meses. Después de la decisión se observó un movimiento similar en el espacio de las terapias alternativas, con MindMed $MNMD cayendo un 15% en las operaciones previas a la comercialización. China ha aprobado a nueve fabricantes de automóviles locales para probar su tecnología de conducción autónoma, incluidos BYD (OTCPK:BYDDF) y NIO $NIO, lo que marca la primera vez que el país ha aprobado las pruebas de tecnologías autónomas de nivel 3 y 4. El programa piloto cubrirá turismos, autobuses y camiones, y las pruebas se llevarán a cabo en siete ciudades, incluidas Beijing y Shanghai. Los fabricantes de automóviles aprobados primero deben perfeccionar sus planes de pruebas y seguridad, que deben recibir luz verde de las autoridades, después de lo cual podrán realizar pruebas en las carreteras. La aprobación sigue a los informes de que Tesla $TSLA se acerca al registro de su software de conducción autónoma total en China. $TSLA Tesla también busca llevar los robotaxis al siguiente nivel en los EE. UU., revelando que la extensión sur de Giga Texas está casi completa, que albergará 50.000 Nvidia $NVDA H100 para capacitación completa en conducción autónoma. De hecho, el director ejecutivo, Elon Musk, espera que la compañía de vehículos eléctricos gaste entre $3B y $4B este año en chips de inteligencia artificial de Nvidia. Musk también aclaró un informe reciente de los medios que reveló que los chips H100 reservados para Tesla se estaban enviando a xAI. El fabricante de automóviles "no tenía un lugar donde enviar los chips Nvidia para encenderlos", tuiteó, "por lo que simplemente se habrían quedado en el almacén". $DLTR Dollar Tree está explorando la venta de su negocio Family Dollar. $GME GameStop de Roaring Kitty cotiza bajo investigación en Massachusetts. Buscando recuperar cuota de mercado, Intel $INTC presenta nuevos procesadores.

Leah Lykos, a dog behaviorist out of Chattanooga Tennessee and guardian to three dogs, Eva, Biggie, and Mia explains how her focus is on movement and somatic work. That makes sense given that she operates from the philosophy that for dogs even more so than for humans there is no separation of mind and body.We discuss something new to me: resistance feeding.The idea behind resistance feeding is to not control the dog's behavior but to provide an appropriate outlet for it.Everything is always on a spectrum, so we discuss how to know if you're allowing stress to dissipate or adding to the dog's stress.In that same sense of knowing if something is helpful or not, we touch on the concept of your dog as a mirror. When is hurting to see it that way and when is it helping?Leah explains how she differentiates between people who are already so aware of their own stress and so focused on solving for that, that it inhibits them in working with their dog,and people who are so detached from their body and their feelings. that they have no idea they may be projecting onto their dog.From there we dig into the inner work we get to do thanks to our dogs.When you have trouble connecting with your dog, what part of yourself do you have trouble connecting with or accepting?How does understanding your dog help to understand yourself?How do we regulate our own nervous system? Leah explains that it is her daily work to figure out how she can stay passionate about what she's doing, without getting completely wrapped up in every single case.Links:Leah's website: https://www.caninemovementlab.com/Instagram: https://www.instagram.com/caninemovementlab/The YouTube Channel: https://www.youtube.com/channel/UCSlbjJXVMBxSGBgkbNWXOZwEpisode website: https://kajsavanoverbeek.com/035-leah-lykos-of-canine-movement-lab-on-somatic-work-and-your-dog-as-your-mirror/

ANNONSSAMARBETE MED QLIRO. I förra veckan samlades tusentals e-handlare på D-Congress i Göteborg och självklart var Breakit på plats.I ett samarbete med Qliro mötte Breakits medgrundare Stefan Lundell några av Sveriges tyngsta e-handelsprofiler.Här är hela laguppställningen:(2:53) Stefan Palm, grundare Lager 157: Jag laddar för ny storaffär i år(36:28) Adlibris-chefen Jonas Karlén - så ska han få fart på lönsamheten(54:03) Doldisen Jonna Gustafsson bygger succébolaget Essnce från Nässjö(01:19:16) Meds-grundaren Björn Thorngren om återförsäljarnas revansch(01:37:25) Så vände Christoffer Rutgersson Qliro till svarta siffror - och det är bara början(01:55:32) Lykos storägare Erika Lyko gör sin första stora intervjuMer information hittar du på Breakit.se och på Qliro.com/foretag berättar Qliro hur deras säkra och enkla betallösningar växer e-handeln.God lyssning! Hosted on Acast. See acast.com/privacy for more information.

Welcome back to The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.Today, I am speaking with Rick Doblin, founder and President of the Multidisciplinary Association for Psychedelic Studies (MAPS).December of last year was a milestone for Doblin and MAPS, as the organization submitted a New Drug Application for MDMA Assisted Therapy to the United States Food and Drug Administration.Then, in the first week of January, the MAPS Public Benefit Corp announced its rebranding to Lykos Therapeutics and a $100 million Series A financing.Needless to say, it has been a pivotal period in the organization's history and a watershed moment for the revival of psychedelic medicine, science, and policy.In February, the FDA accepted the application and granted a priority review, putting the decision timeline at August of this year.That's just around the corner.And so much is still up in the air—of course the big question—will the FDA grant approval? But also so many granular details that will have significant downstream effects on the commercial rollout, access, and cost.* What language will be on the drug label? * What will the Risk Evaluation and Mitigation Strategy entail? * How will patients be able to access the drug? * What will the FDA say about the role of therapy?Among others.So, I wanted to sit down with Rick to talk about it and get his perspective on the organization's evolution, the path ahead, and, most importantly, the many uncertainties that hang in the balance.In this conversation, we discuss:* The importance of therapy in conjunction with MDMA (and his loathing of the acronym MDMA-AT)* The many regulatory and bureaucratic details that go into the FDA's decision and subsequent commercial rollout, including:* Drug labeling* Therapist credentialing * Risk Evaluation and Mitigation Strategies* The negotiations he's led with the FDA over the last 20 years* Lykos' goal of getting MDMA-Assisted Therapy FDA approved and MAPS' goal of getting MDMA federally legalized* The role of therapist's first-hand experience with MDMA and the regulatory battle of ensuring legal access to this group* His future humanitarian and scientific plansAnd much more.And now I bring you my conversation with Rick Doblin.Listen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTubeTheme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Today, we have several news updates from the industry. Let's dive in!The FDA has authorized Florida to import drugs from Canada, allowing the state to purchase lower-cost Canadian medicines in bulk. This decision marks a major shift in the agency's stance and could have significant implications for drug pricing in the US.In other news, Allogene, a biotech company specializing in CAR-T therapy, plans to restructure and shift its strategy. They will conduct a new late-stage study to test whether their "off-the-shelf" therapy can improve cure rates when used early on. This move aims to reposition their therapy and enhance its effectiveness.Moving on, Lykos Therapeutics, formerly known as MAPS Public Benefit Corp., has raised over $100 million for its MDMA-based therapy for PTSD. The company has submitted its MDMA capsules for FDA approval after two positive studies, bringing hope for patients suffering from this debilitating condition.Looking ahead, there are five FDA decisions worth watching in the first quarter of 2024. These include verdicts on new drugs from Eli Lilly and Merck, as well as the potential approval of