Podcasts about Biogen

Biopharma's reaction to the forced resignation of venerable CBER director Peter Marks has been swift and furious, with former FDA Commissioner Robert Califf saying on LinkedIn that “the FDA as we've known it is finished.” Analysts, meanwhile, called Marks' exit “arguably biotech investors' greatest fear,” as company shares across the industry tumbled.   Marks' announcement added insult to injury for the agency, which was already reeling from the announced cuts of 10,000 employees across the Department of Health and Human Services, including 3,500 FDA staffers. Those layoffs began to roll out on Tuesday as some employees showed up to work only to discover they no longer had a job. Amid all this chaos, Cantor Fitzgerald analysts called for Kennedy himself to get the axe, saying in part that he was “undermining the trusted leadership of health care in this country.”    Despite the turmoil, drug development continues in the obesity space, with Novo Nordisk presenting mixed data from its semaglutide franchise at the American College of Cardiology's annual conference last weekend. While an oral version of the blockbuster drug showed cardiovascular benefits for some patients, it failed to change the trajectory of other major adverse cardiovascular events. Meanwhile, Novo continues its battle against compounding pharmacies manufacturing copycat versions of semaglutide—as multiple players scramble for a piece of this massive pie.    On the Alzheimer's front, Eli Lilly's Kisunla failed last week to win the recommendation of the EU's Committee for Medicinal Products for Human Use. This decision is consistent with CHMP's recent stance on anti-amyloid antibodies, as Biogen and Eisai have also struggled to get Leqembi approved in Europe.    On a positive note, pharma R&D returns grew again in 2024, but Deloitte warned that this progress is “fragile.” The firm urged companies to be bold and embrace cutting edge technology like gene therapy and AI. These returns can't help everyone, however, as the past week has seen an uptick in layoffs across biopharma, including at Carisma Therapeutics, Organon and Tenaya Therapeutics.   Finally, as April kicks off cancer conference season, BioSpace took a deep dive into the recent action in the always-hot in radiopharmaceuticals space.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Union has rejected Lilly's Alzheimer's drug Kisunla, citing potential risks of brain swelling and bleeding. This decision follows a similar rejection of a rival drug, Leqembi. Novo Nordisk is facing challenges in its weight loss business due to compounded versions of its drug Semaglutide making up a significant portion of the market. Milestone Pharmaceuticals experienced a setback when the FDA issued a complete response letter for its tachycardia drug Cardamyst. The company is now focusing on restructuring and streamlining operations.Merck's injectable Keytruda has shown promising results in a pivotal trial, and BioNTech's bispecific treatment has elicited positive responses in the majority of patients with small cell lung cancer. Novo Nordisk's stock dipped after disappointing weight loss results for Cagrisema, and Biogen and Eisai's drug Leqembi faced setbacks in the UK and Australia. In other news, United States Pharmacopeia is offering career opportunities in various fields including science, technology, regulatory affairs, and quality assurance. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology industries.

In this CME podcast, Dr. Andrew Cutler and Dr. Roger McIntyre discuss the use of potentially unsafe drug combinations in patients with treatment-resistant psychiatric conditions. They review situations where complex medication regimens may be necessary and how clinicians may proceed in these instances. By addressing these topics, the podcast offers guidance on balancing the potential benefits of combination therapies with the risks associated with polypharmacy in psychiatric care.  Target Audience: This activity has been developed for the healthcare team or individual prescriber specializing in mental health. All other healthcare team members interested in psychopharmacology are welcome for advanced study. Learning Objectives: After completing this educational activity, you should be better able to: Identify common potentially unsafe drug combinations that may be considered in treatment-resistant cases Evaluate the risks and benefits of prescribing potentially unsafe drug combinations for treatment-resistant patients, considering factors such as efficacy, adverse effects, and patient-specific characteristics Develop strategies to monitor and manage patients prescribed potentially unsafe drug combinations Accreditation: In support of improving patient care, this activity has been planned and implemented by HMP Education and Neuroscience Education Institute (NEI). HMP Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Activity Overview: This activity is available with synchronized audio and is best supported via a computer or device with current versions of the following browsers: Mozilla Firefox, Google Chrome, or Safari. A PDF reader is required for print publications. A post-test score of 70% or higher is required to receive CME/CE credit.   Estimated Time to Complete: 1 hour. Released: March 26, 2025*   Expiration: March 25, 2028 *NEI maintains a record of participation for six (6) years. CME/CE Credits and Certificate Instructions: After listening to the podcast, to take the optional posttest and receive CME/CE credit, click: https://nei.global/POD25-01 Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ HMP Education designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse: ANCC contact hours This continuing nursing education activity awards 1.00 contact hour. Provider approved by the California Board of Registered Nursing, Provider #18006 for 1.00 contact hour. Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credits™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.00 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.00 contact hour (.10 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI and HMP Education must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and are unable to report your claimed credit after this 60-day period. Ensure your profile includes your DOB and NABP ID. Physician Associate/Assistant: AAPA Category 1 CME credits HMP Education has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credits for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.00 AAPA Category 1 credit. Approval is valid until March 25, 2028. PAs should only claim credit commensurate with the extent of their participation. Psychology: APA CE credits Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibility for the content of the programs. This activity awards 1.00 CE Credit. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, HMP Education is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. Social workers completing this internet enduring course receive 1.00 general continuing education credit. Non-Physician Member of the Healthcare Team: Certificate of Participation HMP Education awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit™) to a participant who successfully completes this educational activity. Interprofessional Continuing Education: IPCE credit for learning and change This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit for learning and change. Peer Review: The content was peer-reviewed by an MD, MPH specializing in forensics, psychosis, schizophrenia, mood disorders, anxiety, and cognitive disorders — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI and HMP Education take responsibility for the content, quality, and scientific integrity of this CME/CE activity. Disclosures: All individuals in a position to influence or control content are required to disclose any relevant financial relationships. Any relevant financial relationships were mitigated prior to the activity being planned, developed, or presented. Faculty Author / Presenter Andrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences, Norton College of Medicine, State University of New York Upstate Medical University, Syracuse, New York Chief Medical Officer, Neuroscience Education Institute, Malvern, Pennsylvania Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Brii Biosciences, Cerevel, Corium, Delpor, Evolution Research, Idorsia, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Lundbeck, LivaNova, Luye, MapLight Therapeutics, Neumora, Neurocrine, NeuroSigma, Noven, Otsuka, Relmada, Reviva, Sage Therapeutics, Sumitomo (Sunovion), Supernus, Takeda, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, BioXcel, Corium, Idorsia, Intra-Cellular, Ironshore, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Sumitomot (Sunovion), Supernus, Takeda, Teva, Tris Pharma, Vanda Data Safety Monitoring Board (DSMB): COMPASS Pathways, Freedom Biosciences Faculty Author / Presenter Roger S. McIntyre, MD, FRCPC Professor, Departments of Psychiatry and of Pharmacology, University of Toronto, Toronto, Ontario, Canada CEO, Braxia Scientific Corp, Toronto, ON, Canada Grant/Research: Canadian Institutes of Health Research, China National Natural Research Foundation, Global Alliance for Chronic Diseases, Milken Institute Consultant/Advisor: Alkermes, Atai Life Sciences, Axsome, Bausch Health, Biogen, Eisai, Intra-Cellular, Janssen, Kris, Lundbeck, Mitsubishi Tanabe, Neumora Therapeutics, Neurocrine, NewBridge Pharmaceuticals, Novo Nordisk, Otsuka, Pfizer, Purdue, Sage, Sanofi, Sunovion, Takeda, Viatris The remaining Planning Committee members, Content Editors, Peer Reviewer, NEI and HMP planners/staff have no financial relationships to disclose. NEI and HMP Education planners and staff include Gabriela Alarcón, PhD, Ali Holladay, Andrea Zimmerman, EdD, CHCP, Brielle Calleo, and Steven S. Simring, MD, MPH. Disclosure of Off-Label Use: This educational activity may include discussion of unlabeled and/or investigational uses of agents that are not currently labeled for such use by the FDA. Please consult the product prescribing information for full disclosure of labeled uses. Cultural Linguistic Competency and Implicit Bias: A variety of resources addressing cultural and linguistic competencies and strategies for understanding and reducing implicit bias can be found in this handout—download me. Accessibility Statement For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported solely by the provider, NEI.

Episode Links: Daily insights for people development professionals to transform workplace learning and performance together Women Know Exactly What They're Doing When They Use ‘Weak Language' Free writing Reflective Writing Skills The Transformative Power of Reflective Writing in Personal Development Hello Sunshine Women Know Exactly What They're Doing When They Use ‘Weak Language' Skills Hub menu Reflective writing How to Write With AI: Essential Guide, Tools, & Tips (2024) An introduction to the use of generative AI tools in teaching Generative AI and Creative Learning: Concerns, Opportunities, and Choices Brandeis And The History Of Transparency Confidence trick AI - Why it matters to women Women are less confident as writers. Here's why and how to change this — Clementine App The key to change: Women's voice and influence The power of literacy to give women a voice Generative AI Tools Are Perpetuating Harmful Gender Stereotypes Techno-Patriarchy: How AI is Misogyny's New Clothes AI's Missing Link: The Gender Gap in the Talent Pool Women in Data Science and AI 8 of the Best AI Writing Tools to Help You Work Smarter, Not Harder Generative AI in Academic Writing AI Shaming: The Silent Stigma among Academic Writers and Researchers Why you should write for one person This week's guests are: Kim Ellis is a trainer at heart, she loves to see (and inspire) those ‘ah-ha' moments in the people she works with – whether that's in a training capacity or elsewhere. In 2024 Kim's focus shifted from working with clients to working with other self-employed L&D professionals and helping them thrive. https://ldfreespirits.com/ https://www.linkedin.com/in/kim-ellis-20023857/   Jane Daly is a Behavioural Scientist, Executive Coach, Consultant, and Published Author with a wealth of experience in executive roles. Jane is the founder of Peoplestar, an evidence-based multidisciplinary agency specialising in complex culture and capability transformation. As a proud female AI entrepreneur, Jane is dedicated to leveraging AI to redesign work lives, fostering healthier, more ethical and equitable human-technology relationships that enhance long-term health and wellbeing. https://www.linkedin.com/in/jane-daly-msc-fcipd-flpi-568036b   Bold Type Co-Founder Grace Aldridge Foster has been training writers for over a decade. She has worked with organisations including Capital One, Johnson & Johnson, Biogen, the U.S. Special Operations Command, the Aspen Institute, and the DC Public Education Fund. She has taught professional writing at Georgetown University's School of Continuing Studies and McDonough School of Business. Her own writing has appeared in academic publications, Smithsonian Insider, and Forbes, where she is a Careers and Leadership Contributor. Bold Type's website BT LinkedIn BT Instagram: @bold__type Grace's Forbes contributor page Grace's Forbes article about weak language You can contact Women Talking About Learning through our website, womentalkingaboutlearning.com We're on Twitter @WTAL_Podcast You can buy us a coffee to support Women Talking About Learning via Ko-Fi. Or you can email us via hello@llarn.com  

Send us a textDr. Rose Loughlin, Ph.D. is Executive Vice President, Research at Moderna ( https://www.modernatx.com/en-US ), a biotech company harnessing the power of mRNA technology to develop a new class of medicine for a range of unmet medical needs.Dr. Loughlin leads the company's platform science and therapeutics research organization, focusing on pioneering scientific advancements and further strengthening the Moderna's innovative pipeline.Dr. Loughlin previously served as Senior Vice President of Research and Early Development at Moderna, where she played a crucial role in advancing the Company's portfolio and platform strategy since joining in 2016. Before joining Moderna, Dr. Loughlin held roles at Biogen in business development and at L.E.K. Consulting, where she contributed to defining corporate and portfolio growth strategies for biopharmaceutical companies.Dr. Loughlin holds a Ph.D. in Biophysics from the University of California, Berkeley, and a Bachelor of Arts in physics from Harvard University, and did post-doc work in Germany at European Molecular Biology Laboratory.#RoseLoughlin #Moderna #mRNA #MessengerRNA #CancerVaccines #NeoantigenTherapy #Melanoma #RareDisease #IntercellularTherapeutics #PropionicAcidemia #MethylmalonicAcidemia #CMV #Cytomegalovirus  #EpsteinBarrVirus #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #ViralPodcast #STEM #Innovation #Technology #Science #ResearchSupport the show

As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market.   Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession: obesity. In this space, Novo Nordisk has had a rough week, reporting lower-than-expected results from a second straight trial of its next-gen weight loss drug CagriSema. And in an effort to protect revenues from its blockbuster weight-loss drug Wegovy, Novo jumped into the legal battle between the FDA and compounding pharmacies over the regulator's decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing “multiple metric tons” of its investigational obesity medication VK2735 in a deal with CordenPharma. Meanwhile, companies continue to tackle adverse events associated with GLP-1s.  Another space that has seen its fair share of failures in the past couple of years is depression. The latest flop comes from J&J, which announced it would discontinue its a kappa opioid receptor blocker aticaprant after a disappointing Phase III readout. J&J joins Biogen and Sage Therapeutics, Relmada Therapeutics and Alto Neuroscience, all of whom have suffered regulatory misses or trial flops. Finally, two of Donald Trump's healthcare nominees, Marty Makary and Jay Bhattacharya, sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.   

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. J&J has recently halted a late-stage depression trial due to lack of efficacy. Analysts do not believe this will have a significant impact on the company's broader neuroscience strategy. Meanwhile, there seems to be confusion at the FDA with terminations and reversals happening. In other news, Novo Nordisk has conducted limited studies on GLP-1s for addiction. Biogen and Eisai are facing setbacks with Leqembi overseas. There are potential FDA changes under commissioner Marty Makary. The FDA's priority review vouchers are in need of transparency. AstraZeneca has presented strong data for Imfinzi in stomach cancer. Atea Pharmaceuticals has made the decision to cut its workforce. Novo Nordisk is entering a legal battle against GLP-1 compounders, while Lilly has achieved a victory in a different matter. Pharmaceutical executives have recently shared insights on trust, technology, and the future at the WEF. Overall, there are various developments happening in the Pharma and Biotech industry that are worth keeping an eye on.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. AbbVie has recently entered the obesity market through a deal with Gubra for Amylin, worth up to $2.2 billion. This move positions AbbVie among industry leaders like Novo Nordisk and Eli Lilly. The focus on redefining obesity as a chronic disease is gaining momentum, with recent FDA documents and The Lancet Diabetes & Endocrinology commission highlighting the importance of maintenance treatment. In immuno-oncology, experts are searching for the next breakthrough beyond Keytruda and Yervoy. Novel targets, combinations, and pre-emptive immunization are being explored as potential areas of growth. The upcoming World Orphan Drug Congress in 2025 will gather industry leaders to discuss the future of orphan drug development and rare disease care. Positive developments have been reported for Biogen and Eisai's Leqvio in Europe, AstraZeneca and Amgen's Phase III win for Tezspire, and advancements in non-opioid painkillers by Lexicon. The text also discusses the maturation of immuno-oncology, the potential of mRNA technology in rare diseases, recent FDA approvals for rare disease treatments, the evolving mindset towards treating obesity as a chronic disease, and updates on FDA-related news. Lastly, job opportunities in the biotech industry are available at AbbVie, Moderna, Arvinas Inc., and Sonothera. Share your input on topics to cover in the biopharma industry.

Bold Type Co-Founder Grace Aldridge Foster has been training writers for over a decade. She has worked with organizations including Capital One, Johnson & Johnson, Biogen, the U.S. Special Operations Command, the Aspen Institute, and the DC Public Education Fund. She has taught professional writing at Georgetown University's School of Continuing Studies and McDonough School of Business. Her own writing has appeared in academic publications, Smithsonian Insider, and Forbes, where she is a Careers and Leadership Contributor.

On this episode of Biotech Hangout hosts Brad Loncar, Eric Schmidt, Tess Cameron, Luba Greenwood, and Tim Opler, along with special guest Adam Feuerstein, kick off with a discussion on ‘zombie' biotech companies – those trading below their cash value – and whether they can be revived or should return capital to investors. The conversation then turns to Stoke's collaboration agreement with Biogen, Solid Biosciences' promising gene therapy data for Duchenne muscular dystrophy, and industry concerns over biotech fundraising practices. Other key topics include Bluebird Bios take-private acquisition, SpringWorks' potential buyout by Merck KGaA, and updates in the obesity space, including the FDA removing semaglutide from the shortage list. The group also covers BridgeBio's strong launch of Attruby, biotech M&A sentiment, and rumors of a potential Viking Therapeutics acquisition. *This episode aired on February 21, 2025.

We are on the Hill Advocating for a better future – Sprint, DREEM, Travel & NET -  #S10e162 Tuesday, February 25, 2025 - Week 9   ADVOCACY - Thank you Jessica, Jaime and Vicky for repping SRF at ELF RD Week https://www.linkedin.com/posts/curesyngap1_raredc2025-syngap1-advocacy-activity-7300237949831368705-FIRS    SPRINT4SYNGAP - April 26, 2025 Webinar: cureSYNGAP1.org/S4S25 Guide: cureSYNGAP1.org/S4SGuide   LEVERAGE ON OUR GRANTS #Finland #Missense: https://www.linkedin.com/posts/graglia_kulttuurirahastontuella-skr2025-syngap1-activity-7296289488912191489-rWl-/?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAD8f4B7JC4TMss45Q8hrsq5kiceI0Z8HE   STUDY OF THE WEEK - Email syngap-study@beacon.bio Dreem: https://curesyngap1.org/resources/studies/beacon-dreem-eeg-device-study-in-syngap1/    Study Tracker page: https://docs.google.com/spreadsheets/d/1oQLNi85AUbISmcW0KbsgGn4cBK_4MNuvwGlKUUKLyIQ/edit?usp=sharing    IMPACT REPORT NL43 cureSYNGAP1.org/NL43    ONLINE DID YOU KNOW We have a calendar now! https://curesyngap1.org/calendar/ Brochure is updated: cureSYNGAP1.org/Brochure  YouTube - Adding Family Day Talks - https://www.youtube.com/playlist?list=PLjpr3a14_ls2ummdbWyUdvRpMcQBlRXy2    COMPANY OF THE WEEK - Stoke & Biogen! STK ($0.45Bn) partners with BIIB ($20.5Bn) https://investor.stoketherapeutics.com/news-releases/news-release-details/biogen-and-stoke-therapeutics-enter-collaboration-develop-and   #SpecialNeedsTRAVEL e31 of SYNGAP1 Stories. Navarros - cureSYNGAP1.org/Stories  Comments on YouTube are great, see this presentation by SRF's Heather on travel… https://youtu.be/c7S7q_gK4Bk?si=wM4Ter_q8-37Yg8V   RESEARCH UPDATE There are 318 papers on or related to SYNGAP1 since 1998, but 54 of those are in 2024!  So far 10 (Coller included) for 2025. https://pubmed.ncbi.nlm.nih.gov/?term=syngap1&filter=years.1998-2025&sort=pubdate&timeline=expanded Frazier paper on NET: https://onlinelibrary.wiley.com/doi/10.1002/aur.3290   VOLUNTEER SPOTLIGHT Toby and John Brimsek are tireless.  Thank you. https://curesyngap1.org/team/volunteers/emily-brimsek-phd/    VOLUNTEER  Join us: https://curesyngap1.org/volunteer-with-srf/   CONFERENCE Pre-register now: December 4 & 5 – https://cureSYNGAP1.org/Pre25  REGISTER FOR BRAIN DONATION via https://www.autismbrainnet.org/ https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1486227/full   SOCIAL MATTERS - 3,937 LinkedIn.  https://www.linkedin.com/company/curesyngap1/ - 1.28k YouTube.  https://www.youtube.com/@CureSYNGAP1  - 11.5k Twitter https://twitter.com/cureSYNGAP1 - 46.6k Insta https://www.instagram.com/curesyngap1/    NEWLY DIAGNOSED? New families have resources here! https://syngap.fund/Resources    Podcasts, give all of these a five star review! https://podcasts.apple.com/us/channel/syngap1-podcasts-by-srf/id6464522917   Episode 162 of #Syngap10  #CureSYNGAP1 #epilepsy #autism #intellectualdisability #id #anxiety #raredisease #epilepsyawareness  #autismawareness #rarediseaseresearch #SynGAPResearchFund #CareAboutRare #PatientAdvocacy #GCchat #Neurology #GeneChat #F78A1

On this week's episode, Chris Garabedian, Tim Opler, Sam Fazeli, Brian Skorney and Luba Greenwood begin with breaking news on the obesity front with Novo Nordisk's next-gen program, amycretin. The conversation transitions to post-JPM public market sentiment and a reluctance in capital markets. On the flip side, the hosts suggest a positive outlook for venture capital investments despite the public market challenges. The group also highlights the active M&A and licensing deal market, including the significant role of Chinese biotechs in licensing deals. The hosts also discusses the impact of Trump's administration's actions on the biotech sector, including the freeze on NIH activities and the potential withdrawal from the WHO. Other topics include potential of AI in healthcare, Biogen's strategic shifts, Nature Medicine paper on GLP-1 drugs effects, and more. This episode aired on January 24, 2025.

In today's episode of the Yet Another Value Podcast, Host, Andrew Walker, shares his thesis and presentation on Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to pioneering solutions to deliver life-changing brain health medicines, so every person can thrive.For more information and to subscribe to the Yet Another Value Substack, please visit: https://www.yetanothervalueblog.com/Disclosure: long SAGEChapters:[0:00] Episode sponsor: Alphasense[3:21] Introduction - passive vs. active investing[7:32] Overview of $SAGE and why its interesting to Andrew: passive owners in the company, shareholder engagement[13:40] Biogen offer (rejected by Sage) - what happened[17:34] Expert call with OBGYN (thank you, Alphasense!)[21:38] Board needs to weigh opportunity cost of cash burn and options[25:49] Shareholder engagement and IRWD cautionary tale / SAGE board and management compensation[30:54] Biogen / Sage merger - why it makes sense and final thoughtsToday's sponsor: AlphasenseIf you're unfamiliar with AlphaSense, it's a market intelligence platform with the world's premier library of proprietary expert insight. For years now, I've used Tegus for their expert call transcript library, and with AlphaSense's acquisition, the depth and breadth of market research content available has expanded significantly.Why I chose AlphaSense? Unparalleled expert insights—access 150,000+ proprietary expert transcripts, growing by 6,000 per month, covering 24,000+ public and private companies. Comprehensive market intelligence—search 450M+ documents, including company filings, analyst research, expert interviews, and more, all connected for deeper analysis.AI-powered research at scale—complete qualitative research 5-10x faster with advanced generative AI, delivering instant, high-confidence insights. Start your free trial now at: https://www.alpha-sense.com/yavp/

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. A lawsuit against Merck related to the HPV vaccine Gardasil, led by Robert F. Kennedy Jr., has been suspended after confirmation. Biopharma bankruptcies are at a peak, with 14 companies filing for chapter 11 protection in 2023 and numbers remaining high in 2024. Gilead has passed on an option for a cancer drug from Arcus, and Merck has partnered with Epitopea to identify unknown tumor antigens. The American Biomanufacturing Summit is set to take place in April 2025 in San Francisco, bringing together industry leaders for exclusive sessions and networking opportunities. The pharmaceutical industry is facing challenges such as patent cliffs and regulatory changes, with companies like Exelixis looking to next-generation cancer drugs for growth. Novo is seeking $830 million in a fraud case against a Singaporean biotech company over a kidney drug. Additionally, there are insights on site survival for clinical research sites and how biotechs can avoid state and local tax surprises. Trump's administration is reportedly seeking to dismantle parts of the FDA workforce, leading to concerns about job security within the agency.Biopharma bankruptcies remained high in 2024, with 14 companies filing for chapter 11 protection, the most in over a decade. Cour Pharmaceuticals solidified its mission last year with a series a raise. Some biotechs are facing unexpected tax consequences when dealing with big pharma. Several top pharma companies are facing massive patent cliffs, including Merck's Keytruda. Novo seeks $830 million in a fraud case against a Singaporean biotech, while Exelixis looks to next-gen cancer drugs. Biogen and Stoke strike a co-development deal for Dravet syndrome. The FDA faces uncertainty as the Trump team seeks to dismantle the workforce. Aardvark Therapeutics raises $94 million for obesity treatments. Abbott, Life Edit Therapeutics, and Regeneron Pharmaceuticals are hiring for various positions.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Novo Nordisk has filed a lawsuit against Singaporean biotech company KBP Biosciences, alleging fraud in relation to a hypertension and kidney disease drug deal. Novo seeks $830 million in damages, claiming they were misled by the biotech's founder. In other news, Biogen and Stoke have teamed up to develop a treatment for Dravet syndrome, with potential payments of up to $385 million to Stoke. Additionally, Arcus challenges Merck in kidney cancer treatment, Cour Pharmaceuticals enters the myasthenia gravis arena after 10 years of work. On the financial side, AlgoTx faced setbacks in a non-opioid pain trial, while Moderna reported higher-than-expected losses. On a different note, RFK Jr. signals support for the psychedelics space. Lastly, the FDA faces challenges as the Trump administration seeks to dismantle the workforce, leading to concerns about job security within the agency. Thank you for tuning in to Pharma and Biotech Daily.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Lilly and Novo are leading the pharmaceutical industry with their impressive sales growth of GLP-1 drugs, leaving their competitors in the shadows. Meanwhile, Vir Biotechnology is shifting its focus to immunology following the loss of emergency authorization for its COVID-19 antibody.The shadow market of off-brand versions of GLP-1 drugs is causing regulatory headaches, while Trump's policies continue to impact earnings calls in the pharma sector. Gilead is gearing up for a mid-year launch of lenacapavir, and Novartis has made a major acquisition in a $3.1 billion deal for a blood thinner.In other news, Biogen has secured $250 million from Royalty Pharma for a phase III lupus program, while Lilly is making moves in the mesh and cancer sectors. Inventiva is planning to cut its workforce in half to focus on promising mesh candidates, and Novo executives are working to boost sentiment after a recent error.Stay tuned for more updates in the industry, but remember that job opportunities and other information are always available. For further details, reach out to Annalee Armstrong, senior editor at Biospace. Don't forget to subscribe for a personalized email experience tailored to your preferences.

APAC stocks were ultimately mixed with price action somewhat choppy following the similar performance stateside.US President Trump responded "We'll see" when asked if reciprocal tariffs are still coming on Wednesday.European equity futures indicate a marginally positive cash market open with Euro Stoxx 50 future up 0.2% after the cash market closed with gains of 0.6% on Tuesday.FX markets are broadly steady asides from JPY which is the standout laggard across the majors.Looking ahead, highlights include US CPI, OPEC MOMR, BoC Minutes, ECB's Elderson, Fed Chair Powell, Bostic, Waller & BoE's Greene, Supply from UK, Germany & USEarnings from Vertiv, CVS, Barrick Gold, Biogen, Reddit, AppLovin, Robinhood, Heineken, ABN AMRO, Barratt, Redrow, Siemens Energy, Michelin & EssilorLuxottica.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

US President Trump responded "We'll see" when asked if reciprocal tariffs are still coming on Wednesday.European bourses hold an upward tilt pre-US CPI and with tariffs capping optimism; US futures are mixed.USD steady ahead of CPI, JPY is on the backfoot given the yield environment.USTs trade steady ahead of CPI, German yields continue their march higher.Crude slips on inventories which saw a surprise build in headline crude stockpiles, reports suggest there is “some optimism about reaching a solution” on Middle Eastern talks.Looking ahead, US CPI, OPEC MOMR, BoC Minutes, Speakers including Fed Chair Powell, Bostic, Waller & BoE's Greene, Earnings from Vertiv, CVS, Biogen, Reddit.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

Hoy la atención está puesta en el dato de IPC, más alto de lo previsto, y en compañías como CVS Health, Biogen o Kraft Heinz. Lo analizamos con Celso Otero, gestor de Renta 4.

Join Michelle Martin on her tour of markets! DBS posts record earnings and announces new dividends - what does this mean for investors? CapitaLand Ascott Trust, CapitaLand India Trust, and Mapletree Logistics Trust see director buy-ins, while Suntec REIT’s takeover bid fails. In global markets, activist investor Elliott builds a stake in BP, while BYD surges on smart-driving tech. Apple faces UK government scrutiny, and Bank of America sees Warren Buffett’s possible exit. Plus, a preview of earnings from McDonald’s, Coca-Cola, and more.See omnystudio.com/listener for privacy information.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Pfizer announces new breakthrough in cancer treatmentPfizer, a leading pharmaceutical company, has recently announced a major breakthrough in cancer treatment. Their new drug has shown promising results in clinical trials, with a significant increase in survival rates for patients with advanced stages of the disease. This development brings hope to millions of people affected by cancer worldwide.## FDA approves new diabetes medicationThe FDA has approved a new medication for the treatment of diabetes. This drug is expected to provide better blood sugar control and improve overall quality of life for patients with the condition. The approval is a significant milestone in the fight against diabetes, which affects millions of people globally.## Biogen partners with research institute to develop Alzheimer's treatmentBiogen, a biotechnology company, has partnered with a leading research institute to develop a new treatment for Alzheimer's disease. This collaboration brings together the expertise of both organizations to tackle one of the most challenging health issues facing society today. The potential impact of this partnership on Alzheimer's research is immense.## Novartis launches new vaccine for infectious diseaseNovartis, a pharmaceutical giant, has launched a new vaccine for an infectious disease that poses a threat to public health. This vaccine is expected to provide protection against the disease and help prevent its spread. The launch of this vaccine is a significant step forward in the fight against infectious diseases worldwide.## Roche acquires biotech startup for groundbreaking gene therapyRoche, a multinational healthcare company, has acquired a biotech startup that specializes in gene therapy. This acquisition will allow Roche to further develop groundbreaking treatments for genetic disorders and other diseases. The synergy between the two companies is expected to lead to innovative therapies that could revolutionize healthcare.## ConclusionIn conclusion, these recent developments in the pharmaceutical and biotech industry are groundbreaking and have the potential to transform healthcare as we know it. From breakthroughs in cancer treatment to advancements in diabetes medication, the future looks promising for patients around the world. Collaborations between industry leaders and research institutes are paving the way for innovative therapies that could have a lasting impact on global health. Stay tuned for more updates on the latest news and advancements in Pharma and Biotech.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Roche is planning to be cautious with high-priced deals in 2025, prioritizing putting science at the center of its business development decisions. Sanofi's recent earnings were driven by Dupixent and a new RSV vaccine, with a strong focus on R&D and potential M&A deals. Inhibikase has decided to scrap a Parkinson's drug after disappointing mid-stage data, adding to recent setbacks in the field. RFK Jr. faced a divided Senate during his confirmation hearing for HHS secretary, downplaying concerns about his previous anti-vax statements. Vertex is awaiting the FDA verdict on a non-opioid pain drug, while Ironwood has made the decision to cut half of its staff due to disappointing 2025 guidance. Zentalis is planning to lay off 40% of its staff in order to extend its cash runway. The life sciences scene in the Chicago area continues to show growth.In the latest news, The Weekly covers RFK Jr.'s Senate hearing, Sage's rejection of Biogen, and developments in the obesity space. Thank you for tuning in to Pharma and Biotech Daily.

In the week since Donald Trump took office, he's caused quite the stir with healthcare-centered moves that include ordering the Department of Health and Human Services to stop communications, hiring and travel and announcing that he would withdraw the U.S. from the World Health Organization. Wednesday, the U.S. Senate Finance Committee convenes to vote on the controversial nomination of Robert F. Kennedy, Jr. for health secretary—a vote that Jefferies analysts said they expect to be “close.” Biogen continues to grab headlines this month, as the latest chapter in the Sage saga saw the smaller biotech rejecting its neuro partner's unsolicited buyout offer. Meanwhile, Biogen laid off an undisclosed number of employees from its research unit, just as a higher dose of its Ionis-partnered spinal muscular atrophy therapy Spinraza was accepted for review by both the FDA and EMA. Elsewhere, the weight loss space continues to click on all cylinders, with Versant Ventures debuting its newest obesity biotech Helicore Biopharma on Tuesday with $65 million in series A funds, and two obesity-focused companies, Aardvark Therapeutics and Metsera, seeking entry to the public markets. These up-and-comers will have to compete against the likes of Eli Lilly and Novo Nordisk, the latter of which reported data last week showing that its next-gen obesity drug amycretin could elicit up to 22% weight-loss. And Veru announced that its enobosarm could significantly improve the quality of weight loss in seniors also taking Novo's Wegovy. Another busy therapeutic space is Duchenne muscular dystrophy, where analysts predict a lot of action in the next couple of years, with a number of data readouts and regulatory submissions. And finally, Annalee Armstrong caught up at JPM with Novavax CEO John Jacobs, who said the vaccine maker is at a pivot point.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sage has rejected Biogen's unsolicited buyout offer and will seek strategic alternatives. Biogen and Eisai have received approval for a monthly maintenance regimen for Alzheimer's drug Leqembi. Veru's drug has shown promise in sparing lean mass in overweight adults on Wegovy. The Duchenne muscular dystrophy space is on the verge of a pivotal era with several companies developing investigational therapies. Akero has rebounded in a mid-stage trial, Daiichi Sankyo is optimistic for 2025, and Allakos is cutting its workforce. The text discusses the advancements in the Duchenne Muscular Dystrophy (DMD) space as it enters a pivotal era, with companies such as Capricor Therapeutics, Wave Life Sciences, and RegenxBio working on investigational therapies to address unmet needs. It also mentions Daiichi Sankyo's recent success with the approval of Astrazeneca-partnered Dato-DXD. Additionally, new treatments are in development for Achondroplasia to challenge Biomarin's Voxzogo. Novo's obesity drug shows promising results, Merck's Keytruda combo fails in a Phase III trial for GI cancer, and Tris Pharma wins late-stage for a non-opioid painkiller. The text also invites feedback from readers on topics they would like to see covered in the future.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novo has developed a next-generation obesity drug that has shown promising results with up to 22% weight loss in patients. This news comes after a disappointing performance from Cagrisema, which missed Novo's projection of 25% weight reduction in its phase III trial. In other news, Merck's keytruda combination therapy has failed to extend survival in phase III gastrointestinal cancer trials, indicating that the drug may be reaching its limits after numerous approvals. Aardvark Therapeutics has filed for an IPO to advance its lead candidate for obesity treatment. President Donald Trump's actions in his first week in office have caused upheaval in the biopharma industry, including a freeze on communications at major public health agencies. Additionally, Purdue Pharma and the Sackler family have settled opioid lawsuits for $7.4 billion, and Biogen is planning to cut research employees. AbbVie has partnered with Neomorph for a collaboration worth up to $1.64 billion. The biopharma industry is facing uncertainty due to Trump's initial policies and decisions.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world.AbbVie has entered into a collaboration with Neomorph worth up to $1.64 billion for molecular glue. Neomorph, a protein degradation-focused company, has secured its third big pharma deal in less than a year. In other news, Vigil Neuroscience's Alzheimer's treatment has shown early promise in reducing Trem2 levels. Vanda lost a confidentiality complaint against the FDA. Biogen is trimming its research workforce while their higher-dose SMA drug is under regulatory review. Samsung Biologics has secured a $1.4 billion European contract. Teva's Copaxone receives a boxed warning from the FDA. Tris Pharma has recorded a late-stage win for a non-opioid painkiller. J&J predicts that deals are likely to shrink after their $14.6 billion acquisition of Intra-Cellular. In the biopharma industry, there are questions surrounding policies under the new administration. Gilead executives have started over with a new spinoff after almost 5 years into a $5 billion partnership with Galapagos.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. During the latest Johnson & Johnson's Q4 earnings call, the company disclosed a total of $88.8 billion in sales for the full year. They also mentioned a shift in their acquisition strategy, moving towards smaller deals after the massive $14.6 billion purchase of Intra-Cellular. This change will see J&J focusing on single-digit billion buyouts in the future. Arrivent has joined the trend of Chinese licensing deals by potentially entering into a $1.2+ billion agreement with Lepu to advance an antibody-drug conjugate for gastrointestinal cancers. Meanwhile, Gilead is starting fresh after nearly five years into their $5 billion partnership with Galapagos, as they explore new opportunities with a spinoff company. President Trump's recent executive orders have sparked some concerns within the biopharma industry, despite most executives expressing a neutral stance towards his administration at the J.P. Morgan conference. The newsletter also covers topics such as FDA pausing Atara's programs, Chinese biotech Ascentage aiming for a $134 million IPO, and Johnson & Johnson's Spravato making advancements in the challenging depression space with monotherapy approval.Biopharma executives at J.P. Morgan maintained a neutral outlook towards the incoming Trump administration, but worries arose when Trump issued executive orders impacting the industry. Gilead's partnership with Galapagos is evolving after five years, leading to the creation of a new spinoff company. The rise of China's biopharma innovation may face obstacles due to Trump's trade policies. Other highlights from the newsletter include personal anecdotes from J.P. Morgan, Chinese biotech Ascentage gearing up for an IPO, SAGE taking legal action against Biogen, and investment trends for 2025 focusing on immunology and obesity. Notch Therapeutics announced layoffs, while companies like Akron Biotech, Visterra Inc., and Insmed Incorporated are currently hiring for various positions in the biopharma industry.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna has received nearly $600 million in funding from HHS for mRNA-based bird flu vaccines, with the goal of having these vaccines ready before potential human outbreaks. As 2025 begins, there is a predicted shift towards investments in immunology, inflammation, obesity, neuromuscular, kidney, and cardiovascular diseases. Sage is suing partner Biogen after an unsolicited takeover offer, and Astrazeneca and Daiichi Sankyo's ADC has won its first approval despite mixed data. Analysts and biotech executives also highlight a pivot towards cell therapy for autoimmune diseases and continued interest in next-generation obesity drugs.Analysts and biotech executives predict a focus on immunology, inflammation, obesity, neuromuscular, kidney, and cardiovascular diseases in 2025. Cell therapy is shifting towards autoimmune diseases. Key stories include setbacks for the Astrazeneca/Daiichi Sankyo antibody-drug conjugate, new treatments for celiac disease gaining traction, and advancements in reframing multiple myeloma from fatal to treatable. Novo Nordisk's high-dose Wegovy shows increased weight loss in a Phase III trial, AstraZeneca receives full FDA approval for a lymphoma treatment, and Pfizer is optimistic about an obesity pill. Johnson & Johnson makes a major neuro play with a $14.6 billion buyout.

Donald Trump was sworn in as the 47th president of the United States on Monday, bringing with him a host of healthcare nominees and potential changes to the FDA, M&A and drug pricing. The new administration was a key focus point at the 2025 J.P. Morgan Healthcare Conference last week, where Annalee Armstrong spoke to executives from several companies about what they're expecting from a second Trump term. Also at JPM, Mirador Therapeutics CEO Mark McKenna boldly predicted that 2025 would see the return of the megamerger. Speaking of M&A, Annalee spoke with leaders from Biogen, who declined to address the company's unsolicited takeover bid for Sage Therapeutics. For its part, Sage sued Biogen last week, “seeking preliminary injunctive relief to enforce a standstill agreement.” Meanwhile, Gilead CEO Daniel O'Day addressed the split of Galapagos—a company Gilead has poured more than $5 billion into since 2019. Check out more personal stories from JPM here. In the obesity space, Novo Nordisk reported data from a Phase III trial showing that a high dose of Wegovy elicited more weight loss than the approved regimen—but still fell short of results posted by Eli Lilly's Zepbound. Relatedly, Wegovy and sister drug Ozempic are both on the list of the next fifteen drugs whose prices could be negotiated under the Inflation Reduction Act. Finally, the FDA on Friday made its first high-profile decision of the year, greenlighting AstraZeneca and Daiichi Sankyo's Dato-DXd—now Datroway—to treat certain types of advanced breast cancer. The approval is the first for the highly touted antibody-drug conjugate, which is also under FDA review for EGFR-mutated non-small cell lung cacner. Analysts expect 2025 to be a pivotal year for the ADC.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/NCN865. CME/MOC/AAPA credit will be available until January 19, 2026.The Future of Care in Postpartum Depression: Comprehensive Strategies for Early Diagnosis and Effective Treatment In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Sage Therapeutics and Biogen.Disclosure information is available at the beginning of the video presentation.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Wegovy, a drug by Novo Nordisk, has shown increased weight loss in a phase III trial when given at a high dose, nearly matching the efficacy of Zepbound. Drugmakers like Novo Nordisk and Boehringer Ingelheim are facing pressure in drug price negotiations, with Novo's Ozempic and Wegovy being targeted. Predictions for 2025 deals and fundraising were discussed at JPM, with executives making predictions for the industry. AGC Biologics offers validation before GMP for gene of interest candidates to accelerate timelines. In other news, AstraZeneca gets full FDA approval for a lymphoma treatment, Novartis is trying to prevent copycats as generics gain ground, and Amgen wins colorectal cancer expansion for Lumakras. At JPM25, biopharma deals are starting to flow, with one deal dwarfing last year's activity. Biogen executives are deflecting urgency to make deals at JPM25.

How are boards of directors navigating the complex world of enterprise AI and AI adoption? Join Michael Krigsman in conversation with independent board member Adriana Karaboutis (former technology leader at Dell, Biogen, National Grid) as they dissect the current state of AI adoption across industries. Discover the key drivers and roadblocks, the tension between innovation and risk, and what to do when board members lack tech understanding. This is a must-watch for CEOs, CIOs, and anyone who shapes their organization's AI strategy.

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.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma & Biotech world.The J.P. Morgan Healthcare Conference saw a surge in biopharma deals, with companies like Eli Lilly, GSK, and Gilead announcing billion-dollar deals. Pfizer and Kailera Therapeutics presented updates on obesity treatments, while Biogen and Eisai are seeking FDA approval for new formulations of an anti-amyloid antibody. Other news includes Regeneron's success in a phase III skin cancer trial and Lilly's acquisition of a new molecule. The industry sentiment has been boosted by the flurry of deals at the conference.

The J.P. Morgan Healthcare Conference kicked off Monday with a flood of high-value deals, reinvigorating sentiment across the biopharma industry. Johnson & Johnson made the biggest splash, acquiring neurology leader Intra-Cellular Therapies for $14.6 billion, while GSK picked up precision therapy specialist IDRx for $1B upfront and Eli Lilly laid down up to $2.5 billion for Scorpion's PI3Kα inhibitor program. Meanwhile, the immunology and inflammation space continues to fire on all cylinders as Gilead invests up to $1.7 billion for LEO Pharma's preclinical oral small molecule STAT6 program. And those are only the deals accepted by both parties. Prior to the conference, Biogen offered to acquire its struggling neuro partner Sage Therapeutics for around $469M. The proposal follows a catastrophic run for Sage, which has seen its shares fall more than 90% in the past two years. 2024 sales and earnings forecasts have also generated attention this week, with Sarepta reporting that Duchenne muscular dystrophy gene therapy Elevidys beat analysts' expectations in the fourth quarter, and Eli Lilly projecting a full-year revenue miss driven largely by lower-than-expected sales of GLP-1 blockbusters Zepbound and Mounjaro. As expected, obesity has been a hot topic at JPM, with Pfizer CEO Albert Bourla announcing that his company is going “all in” in the space. This follows new FDA guidance revealed last week recommending a minimum weight loss threshold for drug developers. Among the many companies taking notice is newcomer Verdiva Bio, which launched last week with more than $410 million in opening funds. Also debuting last week was Kardigan, which raised $300 million to tackle heart disease. Kadigan joins a resurgent cardiovascular space, where several companies—including those developing gene therapies—are targeting myriad diseases. Finally, BioSpace senior editor Annalee Armstrong caught up with Daphne Zohar, CEO of BioSpace NextGen 2025 company Seaport Therapeutics Daphne Zohar, who offered her thoughts on the current state of the neuropsychiatric space.

Timestamps: 4:19 - Die Forschung nach einem Psoriasis Medikament 9:45 - Biogen beteiligt sich an der Forschung nach MS Medikament 32:22 - Das OYM -  Ein wissenschaftlicher Approach zum Spitzensport 44:05 - Das Businessmodell hinter dem OYM 48:50 - Erfolg trotz Gegenwind - gestärkt durch die Kritiker Über Hans-Peter Strebel: Hans-Peter Strebel ist der Gründer von Fumapharm, einem Unternehmen, das ein bahnbrechendes Medikament zur Behandlung von Psoriasis und Multipler Sklerose (MS) entwickelt hat. Sein Weg führte von einer kleinen Apotheke im aargauischen Muri bis zum erfolgreichen Verkauf von Fumapharm an Biogen. Strebel gründete auch das OYM, ein hochmodernes Sportzentrum in der Schweiz, das seine Leidenschaft für Innovation und einen wissenschaftlich fundierten Ansatz für sportliche Leistungen widerspiegelt. Das Titelbild wurde von www.smartportrait.io bearbeitet. Folge uns auf Twitter, Instagram, Facebook und Linkedin um auf dem Laufenden zu bleiben. Wir posten regelmässig über Live Shows, Give-Aways und unsere Founders Dinner Events.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Johnson & Johnson has made a significant move in the neurology field by acquiring Intra-Cellular for $14.6 billion, gaining access to assets such as Caplyta for schizophrenia and bipolar depression. Biogen has submitted an offer to acquire Sage Therapeutics after facing regulatory and clinical challenges. Gilead is diversifying with a potential $1.7 billion inflammation pact with Leo, focusing on targeting stat6. The FDA's evolving biomarker focus was highlighted by a committee's decision to limit the use of Keytruda and Opdivo in certain cancers based on PD-L1 expression levels. AGC Biologics is offering representative scale-down data for gene of interest candidates before committing to a GMP contract, potentially accelerating timelines by up to 6 months. Other news includes GSK's acquisition of Idorsia targeting rare cancer, AbbVie absorbing the cost of a schizophrenia failure, and collaborations between Merus and Biohaven. Additionally, five novel FDA approvals have been achieved in 2024, while Passage Bio is cutting staff to extend cash runway.The FDA's evolving focus on biomarkers is reflected in the scrutiny of Keytruda and Opdivo for stomach and esophageal cancers based on PD-L1 expression levels. This trend leverages ever-maturing datasets to make more informed decisions about drug approvals. In addition, five novel FDA approvals in 2024 included new mechanisms of action in oncology and neurosciences. Gene therapies for cardiovascular diseases like congestive heart failure and cardiomyopathy are advancing in the clinic, benefiting from technological advancements and positive early data. The NextGen Class of 2025 startups are focusing on ADCs, radiopharmaceuticals, and cell and gene therapies. Pfizer's subcutaneous PD-1 blocker showed positive results in bladder cancer trials, while Denali and AbbVie/Calico faced setbacks in ALS trials. The FDA is proposing setting a bar for weight-loss therapies as the obesity space heats up, with Metsera touting powerful weight loss results.

US futures are indicating a lower open today. European equity markets have opened with losses, following weaker levels in Asian markets. Market sentiment still impacted by unambiguously strong US payrolls. Bond yields higher and lofty equity valuations under scrutiny as US earnings season approaches. Long-end selloff also fueling discussions around rising term premia amid fiscal deficit concerns for US and UK, amid speculation of increased US corporate takeovers due to weak GBP.Companies mentioned: Sage Therapeutics, Biogen, Intra-Cellular Therapies, Johnson & Johnson, Nippon Steel, United States Steel

Akston Biosciences is revolutionizing pet healthcare through innovative protein engineering and biotechnology solutions. After selling his first company Smart Cells to Merck for over $500M, Todd Zion founded Akston Biosciences in 2011 to apply advanced biotech expertise to the growing pet health market. With over $50M in funding, Akston is developing breakthrough treatments including once-weekly insulin, cancer therapies, and other protein-based medicines for pets, while maintaining cost effectiveness for pet owners. Topics Discussed:  The transition from human health biotech to the pet health market  Streamlined clinical trial processes in pet health vs. human health  The evolution of the pet healthcare market and consumer willingness to pay  Balancing technical innovation with cost-effective development  The challenges of fundraising in an emerging biotech category  Pipeline development across multiple pet health conditions   GTM Lessons For B2B Founders:  Navigate pivots decisively: Todd emphasized that most founders wait too long to pivot. He advises that when you start seeing signs that the future isn't unfolding as planned, that's the time to begin considering a pivot - while you still have resources and before becoming too entrenched. Their pivot to focusing entirely on pet health required significant restructuring but ultimately created a clearer path forward. Find the regulatory sweet spot: Akston discovered that pet health offered a faster path to market validation compared to human health biotech. The ability to conduct field trials with just hundreds rather than thousands of subjects, combined with more streamlined regulatory requirements, allowed them to de-risk their assets more quickly and cost-effectively while still maintaining high standards. Build for the actual market conditions: Rather than assuming future market changes (like expanded pet insurance coverage), Akston designs their products around current market realities - namely that most pet medications are paid out-of-pocket. This forced them to innovate not just technically but in development and manufacturing to keep costs accessible to pet owners. Create new categories through technology translation: Instead of building an entirely new technology, Akston applied proven biotech approaches from human health to the pet market. This allowed them to leverage existing expertise while pioneering a new category, positioning themselves as "the Biogen for pets" rather than just another pet health company. Structure early testing for rapid validation: By utilizing the FDA's investigational new animal drug application process, Akston could begin testing in their target population much earlier in development. This enabled them to validate their concepts within a year rather than waiting through multiple phases of trials, allowing for more efficient resource allocation.     //   Sponsors: Front Lines — We help B2B tech companies launch, manage, and grow podcasts that drive demand, awareness, and thought leadership. www.FrontLines.io The Global Talent Co. — We help tech startups find, vet, hire, pay, and retain amazing marketing talent that costs 50-70% less than the US & Europe.  www.GlobalTalent.co    

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ##News 1: Pfizer announces positive results for new cancer drugPfizer has recently announced positive results from a phase 3 clinical trial for their new cancer drug. The drug showed a significant increase in overall survival rates compared to standard treatments. This is great news for patients with this type of cancer and could potentially lead to a new treatment option in the near future.##News 2: FDA approves new gene therapy for rare genetic disorderThe FDA has approved a new gene therapy for a rare genetic disorder that affects children. This therapy has shown promising results in clinical trials, with patients experiencing significant improvements in their symptoms. This approval marks a major milestone in the field of gene therapy and provides hope for patients with rare genetic disorders.##News 3: Biogen announces breakthrough Alzheimer's drugBiogen has announced a breakthrough in the treatment of Alzheimer's disease with their new drug. The drug has shown to significantly slow the progression of the disease in clinical trials, offering hope to millions of patients and their families. This development could potentially change the landscape of Alzheimer's treatment moving forward.##News 4: Moderna ramps up production of COVID-19 vaccineModerna has announced plans to ramp up production of their COVID-19 vaccine in order to meet global demand. The company has already distributed millions of doses worldwide, with plans to increase production even further in the coming months. This is a positive step towards achieving widespread vaccination and controlling the spread of the virus.##News 5: Novartis partners with research institute on new drug discoveryNovartis has entered into a partnership with a leading research institute to collaborate on new drug discovery efforts. This collaboration brings together expertise from both organizations to accelerate the development of innovative therapies for patients. The partnership highlights the importance of collaboration in driving scientific advancements in the pharmaceutical industry.

T. Scott Clendaniel has been a pioneer and leader in Data Science and Artificial Intelligence since his career began in 1986. Scott's employers/ clients have included 3M, Ameritrade, Biogen, Booz Allen, Bristol-Myers Squibb, FDIC, Mercedes, Morgan Stanley, The Los Angeles Times and a host of other marquee names. He sits on several boards of directors and is constantly mentoring the next generation. Additionally, he has been a guest lecturer at both Johns Hopkins University and the University of Maryland.

Part 4 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Part 3 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Part 2 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD-PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Part 1 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD-PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.