Podcast appearances and mentions of sage therapeutics

In this CME podcast episode, Dr. Andrew Cutler interviews Dr. Phillip Coffin, Director of the Center on Substance Use and Health in San Francisco, CA, about the management of stimulant use disorders. They explore the challenges of treatment and highlight the importance of harm reduction strategies to enhance patients' quality of life.  CME credit is available to NEI Members only.   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: Summarize pharmacologic and behavioral treatment strategies for stimulant use disorders, particularly methamphetamine and cocaine Evaluate the evidence base for current and investigational medications used in clinical trials and real-world settings Apply harm reduction principles and integrated care models to improve outcomes for patients with stimulant use disorders in diverse clinical settings 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: June 18, 2025*   Expiration: June 17, 2028 *NEI and HMP Education maintain 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/POD25-02.  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 June 17, 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. Peer Review: The content was peer-reviewed by an MD, LFAPA specializing in psychiatry, forensic, addiction to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI and HMP Education takes 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. Disclosures are from the original live presentation, unless otherwise noted. 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, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Phillip Coffin, MD, MIA Director of Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA No financial relationships to disclose. The remaining Planning Committee members, Content Editors, Peer Reviewer, and NEI 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, Stephen Daniels and Bahgwan Bahroo, MD, LFAPA. 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.

This week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year's BIO Conference in Boston. The half-team discusses this week's biggest news: the death of another patient who took Sarepta's Duchenne muscular dystrophy gene therapy Elevidys. The patient was a non-ambulatory teenager who experienced acute liver failure after receiving the gene therapy, which is the same cause of death for an Elevidys patient reported in March. Sarepta announced that it was halting treatments to non-ambulatory patients and on a media call discussed new steps in its therapeutic protocol for preventing further liver injuries.  Elsewhere, mergers and acquisitions are surging across biopharma. Eli Lilly picked up the gene editing company Verve Therapeutics for $1.3 billion, which helped bolster the gene editing space —particularly after Sarepta's report of the death. Supernus bought Sage Therapeutics for $795 million, five months after Sage rejected a smaller offer from Biogen.  BioNTech also got in on the dealmaking, buying its German rival—scientifically and in the courtroom—CureVac for about $1.25 billion. The deal seemed focused mostly on CureVac's early-stage cancer immunotherapy pipeline, but analysts were otherwise left scratching their heads on what BioNTech was getting for its money.  Last week on The Weekly the team discussed the sudden dismissal of the CDC's entire ACIP committee, and this week we have a new slate of members. The eight people replacing the 17 members that were removed last week include allies of HHS Secretary Robert F. Kennedy Jr., many of whom are vaccine skeptics who seem to share his skeptical view of vaccination in general.  

Maternal mental health requires a fundamental shift in perception and treatment. In this episode, Chris Benecchi, Chief Operating Officer at Sage Therapeutics, talks about maternal mental health, specifically postpartum depression, and the initiatives Sage Therapeutics is undertaking. He talks about how they're developing innovative therapies and creating partnerships across the healthcare ecosystem. Chris also explains the importance of grassroots efforts, public health collaboration, and the personal impact of postpartum depression. Tune in and learn about the latest innovations in maternal mental health! Resources: Connect with and follow Chris Benecchi on LinkedIn. Follow Sage Therapeutics on LinkedIn, Instagram, Facebook, X, and visit their website.

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.

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.   

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/

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.

About Chris Benecchi:Crhis Benecchi Is the Chief Operating Officer at Sage Therapeutics, where he leads global commercial strategy, medical affairs, and business operations. With a passion for public health and personal experience with postpartum depression, Chris is dedicated to driving impactful change in maternal mental health.Things You'll Learn:Reframing conversations around maternal mental health is essential for addressing this critical issue.Postpartum depression remains prevalent, highlighting a lack of innovation in addressing maternal mental health needs.Sage Therapeutics develops innovative therapies with a focus on improving access and affordability.Partnerships and grassroots efforts play a pivotal role in driving change within the healthcare ecosystem.Resources:Connect with and follow Chris Benecchi on LinkedIn.Follow Sage Therapeutics on LinkedIn, Instagram, Facebook, X, and visit their website. 

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.

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

Get inspired by this discussion with Barry Greene, CEO of Sage Therapeutics, as we discuss the challenges, the hope, and the pursuit of what's possible with brain health. 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Trump has chosen Jay Bhattacharya from Stanford as the new head of the National Institutes of Health, adding to his controversial cabinet picks. Meanwhile, Eli Lilly is currently the best performing pharmaceutical stock of 2024. The newsletter will be taking a break for Thanksgiving and will return on December 2nd with more biopharma news. In other news, PTC has discontinued an ALS asset after a mid-stage failure, BridgeBio's ATTR-CM drug has been approved, Cassava's Alzheimer's drug has failed in Phase III, and Amgen's Maritide did not impress investors. Eli Lilly has seen a significant improvement in its share price this year, while other pharmaceutical companies have not been as fortunate. Additionally, there have been layoffs at Novartis, Recursion, and Kronos. Legal challenges over Lilly's GLP-1 shortages and Sarepta's investment in Arrowhead for RNA drugs are also highlighted.Eli Lilly leads the list of the biggest share movers in the pharmaceutical industry this year, with a significant improvement in its share price. However, other companies like Amgen have faced disappointments, with their weight loss drug Maritide falling short of investor expectations. Sage Therapeutics also suffered setbacks with the discontinuation of its lead candidate Dalzanemdor after clinical failures. Legal challenges over Lilly's GLP-1 shortages have highlighted the FDA's vulnerability post-Chevron deference. In other news, Roche acquires Poseida, Sarepta aims to diversify its pipeline with RNA drugs, and Trump's cabinet picks raise uncertainty in the biopharma environment. Novartis CEO promises more deals, while companies like Novartis, Recursion, and Kronos have announced layoffs. Subscribe for more relevant updates from BioSpace.

In this CME podcast, Dr. Andrew Cutler interviews Dr. Jonathan Meyer about the history of muscarinic receptor science in schizophrenia and how that informs the mechanisms of action of novel muscarinic-targeting drugs for this disorder. They also discuss the efficacy and safety of these drugs and provide practical strategies for prescribing xanomeline-trospium.  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: Discuss the history of muscarinic receptor science and the role of muscarinic receptors in schizophrenia treatment Differentiate novel and in-development muscarinic-targeting treatments for schizophrenia based on their unique mechanisms of action, efficacy, and tolerability data   Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: November 27, 2024*   Expiration: November 26, 2027 *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/POD24-SCHIZ01  Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI designates this enduring material for a maximum of 1.0 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 NEI designates this Enduring Material for a maximum of 1.0 ANCC contact hour Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.0 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.0 contact hour (.10 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.0 AAPA Category 1 credit. Approval is valid until November 26, 2027. 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. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, NEI 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 general continuing education credits. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)™) 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 Interprofessional Continuing Education (IPCE) credit for learning and change. Peer Review: The content was peer-reviewed by an MD specializing in psychiatry and psychopharmacology — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. 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, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Jonathan M. Meyer, MD Voluntary Clinical Professor, Department of Psychiatry, University of California, San Diego School of Medicine, La Jolla, CA Consultant/Advisor: AbbVie, Alkermes, Bristol Myers Squibb, Intra-Cellular, Neurocrine, Sumitomo, Teva Speakers Bureau: AbbVie, Alkermes, Axsome, Bristol Myers Squibb, Intra-Cellular, Neurocrine, Teva The remaining Planning Committee members, Content Editors, Peer Reviewer, and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Caroline O'Brien, Gabriela Alarcón, PhD, Meghan M. Grady, BA, Andrea Zimmerman, EdD, CHCP, and Brielle Calleo. 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 Contact Us: For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported by an educational grant from Bristol Myers Squibb.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Next-generation antibody-drug conjugates (ADCs) are driving a renaissance in the oncology drug class, with companies like ADC Therapeutics, Sutro Biopharma, and Zai Lab developing new ADCs to address challenges with payload and toxicity. BridgeBio recently secured FDA approval for its drug to treat ATTR-CM, launching competition with Pfizer in the market. Meanwhile, Sage Therapeutics faced setbacks with the discontinuation of its lead candidate for Huntington's disease after a third clinical failure. Applied Therapeutics is awaiting FDA verdict on a rare disease therapy, while AstraZeneca successfully defended its drug Andexxa against safety concerns. Other developments include patient death in a Rett syndrome trial, Merck's asthma drug Singulair potentially linked to mental health problems, and Intellia's CRISPR gene editor showing promise in ATTR amyloidosis.The biopharma industry is seeing advancements and challenges across various therapeutic areas, prompting discussions on future coverage topics in neuroscience, oncology, cell & gene therapy, and more.

Update about Sage Therapeutics with Lauren Holder

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Sage Therapeutics has decided to discontinue the development of a drug for Huntington's disease after disappointing results in Phase II trials. This comes after previous failures in studies for Parkinson's and Alzheimer's diseases. In other news, Novo Nordisk and Viking Therapeutics have presented promising data on GLP-1 therapies at AASLD 2024, potentially shaping the future of treatment for metabolic disorders. Pfizer has won a patent lawsuit against GSK in the UK regarding a respiratory syncytial virus vaccine, positioning both companies to compete in the global market.Additionally, controversial TV personality Dr. Oz has been chosen by Trump to head the agency overseeing Medicare and Medicaid. SignalChem Biotech offers kinase drug discovery solutions, supporting researchers with a wide range of services. This news update also covers Pfizer's executive changes, RFK Jr.'s nomination to HHS, and the challenges faced by rare disease players in funding research and development.

In this CME episode, Drs. Andrew Cutler and Roger McIntyre discuss the challenges and importance of diagnosing bipolar disorder as early as possible in the course of the illness. They also review strategies to achieve a correct diagnosis to provide the most efficacious and tolerable treatments available for bipolar disorder. 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: Employ effective screening tools and assessment strategies to enhance diagnostic accuracy and achieve early diagnosis of bipolar disorder Develop patient-centered treatment plans that incorporate current evidence and individual patient factors Utilize shared decision-making approaches to optimize treatment outcomes for patients with bipolar disorder Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: November 01, 2024*   Expiration: October 31, 2027 *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/POD24-BD Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI designates this enduring material for a maximum of 1.0 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 NEI designates this Enduring Material for a maximum of 1.0 ANCC contact hour Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.0 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.0 contact hour (.10 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.0 AAPA Category 1 credit. Approval is valid until OCtober 31, 2027. 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. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, NEI 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 general continuing education credits. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)™) 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 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, cognitive disorders — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. 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, Ontario, 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, and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Caroline O'Brien, Gabriela Alarcón, PhD, Andrea Zimmerman, EdD, CHCP, and Brielle Calleo. 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 Contact Us: For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported by an unrestricted educational grant from Alkermes, Inc.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche CEO opposes Novo Holdings' acquisition of Catalent, urging for it to be blocked. Roche exceeded Q3 sales expectations, driven by the success of drugs like Ocrevus and Vabysmo. Pfizer's RSV vaccine has been approved by the FDA for a wider adult population. Novo Nordisk has raised concerns with the FDA about the complexity of compounders producing its drug Semaglutide. Alto Neuroscience's depression treatment did not meet expectations in a mid-stage trial, echoing Acelyrin's setback last year. Trilink Biotechnologies has launched customized mRNA sets for screening studies. Updates on Trodelvy's withdrawal for bladder cancer, Sage Therapeutics' layoffs, and more are also featured. Pfizer has downsized with 75 job cuts at a North Carolina site. Opportunities in the life sciences industry are also highlighted.Thank you for listening to Pharma and Biotech Daily, stay tuned for more updates.

In this CME episode, Dr. Andy Cutler interviews Dr. Leslie Citrome about the impact of tardive dyskinesia on patient-reported outcomes and quality of life. They discuss how to correctly assess and diagnose tardive dyskinesia, as well as effective management strategies that incorporate the individual needs of patients.  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: Understand the physical, psychological, social, and occupational impacts of tardive dyskinesia (TD) on patients Identify clinical tools and patient-reported outcome measures to assess the severity and impact of TD Formulate evidence-based treatment strategies for TD that enhance patient outcomes and quality of life Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: October 23, 2024*   Expiration: October 22, 2027 *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/POD24-TD   Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI designates this enduring material for a maximum of 1.0 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 NEI designates this Enduring Material for a maximum of 1.0 ANCC contact hour Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.0 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.0 contact hour (.10 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.0 AAPA Category 1 credit. Approval is valid until OCtober 22, 2027. 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. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, NEI 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 general continuing education credits. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)™) 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 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, cognitive disorders — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. 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, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Leslie Citrome, MD, MPH Clinical Professor, Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY Consultant/Advisor: AbbVie/Allergan, Acadia, Adamas, Alkermes, Angelini, Astellas, Avanir, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cadent Therapeutics, Cerevel, Clinilabs, COMPASS, Delpor, Eisai, Enteris BioPharma, HLS Therapeutics, Idorsia, INmune Bio, Impel, Intra-Cellular Therapies, Janssen, Karuna, Lundbeck, Luye, Lyndra, MapLight, Marvin, Medavante-ProPhase, Merck, Mitsubishi-Tanabe Pharma, Neumora, Neurocrine, Neurelis, Noema, Novartis, Noven, Otsuka, Ovid, Praxis, Recordati, Relmada, Reviva, Sage, Sumitomo/Sunovion, Supernus, Teva, University of Arizona, Vanda Speakers Bureau: AbbVie/Allergan, Acadia, Alkermes, Angelini, Axsome, BioXcel, Eisai, Idorsia, Intra-Cellular Therapies, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Recordati, Sage, Sunovion, Takeda, Teva Stockholder: Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer, Reviva (options) The remaining Planning Committee members, Content Editors, Peer Reviewer, and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Caroline O'Brien, Gabriela Alarcón, PhD, Andrea Zimmerman, EdD, CHCP, and Brielle Calleo. 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 Contact Us: For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported by an unrestricted educational grant from Teva Pharmaceuticals.

Guest: Jennifer L. Payne, MD Guest: Melissa Simon, MD Since postpartum depression is a serious medical condition that can negatively impact mothers, infants, and partners, it is important to identify symptoms in a timely manner.1-4 Dr. Jennifer Payne and Dr. Melissa Simon are here to share their clinical experiences screening patients for postpartum depression, explore strategies to overcome common challenges in screening, and identify best practices for collaborating in the care of perinatal women. Dr. Payne is a Professor of Psychiatry and Neurobehavioral Sciences as well as Obstetrics and Gynecology at the University of Virginia, and Dr. Simon is a Professor of Obstetrics and Gynecology at the Northwestern University Feinberg School of Medicine. References American Psychiatric Association. Depressive disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5™. 5th ed. American Psychiatric Publishing; 2013:155-188. Campbell SB, Cohn JF, Meyers T. Depression in First-Time Mothers: Mother-Infant Interaction and Depression Chronicity. Dev Psychol. 1995;31:349-357. Moore Simas TA, Huang MY, Patton C, et al. The humanistic burden of postpartum depression: a systematic literature review. Curr Med Res Opin. 2019;35(3):383-393. Thompson KS, Fox JE. Post-partum depression: a comprehensive approach to evaluation and treatment. Ment Health Fam Med. 2010;7(4):249-257. Sage Therapeutics and the Sage Therapeutics logo …

Last week, Gilead withdrew Trodelvy in bladder cancer after the antibody-drug conjugate failed to meet the primary endpoint in a confirmatory study. This follows Pfizer's recent withdrawal of another therapy that had earned FDA accelerated approval, Oxbryta for sickle cell disease. With few other options available to patients, BioSpace took a look at 5 sickle-cell candidates currently in clinical trials.   Following a disappointing Alzheimer's readout, the company's third neuro stumble in six months, Sage Therapeutics will lay off over 165 employees—about 33% of its workforce. The company is reporting Q3 earnings on Oct. 29.  On a more positive note, Vertex reported full Phase III data this week for its non-opioid pain treatment, su-zetri-gine. If approved, suzetrigine, which has a PDUFA date of Jan. 30, 2025, would be the first new class of acute pain medicine in more than two decades. And on Monday, a company that never leaves the news, Novo Nordisk, announced positive results from a cardiovascular study with its oral version of semaglutide, Rybelsus. In other Novo news, scrutiny around Novo Holdings' acquisition of Catalent is heating up with a coalition of unions, consumer groups and public interest organizations last week expressing their concerns about the buyout. This prompted BioSpace to unpack the unique structure of the collection of organizations that is Novo. Finally, Sanofi is having a busy month, securing the sale of its healthcare unit Opella and separately paying approximately $326 million to obtain a 16% stake in European radiopharma biotech Orano Med. Radiopharma is skyrocketing in popularity, and some companies are even trying to marry it with another hot therapeutic spaces: antibody-drug conjugates. Could radiolabeled ADCs overcome some of the side effects of radiation treatments, speed up treatment times and enable lower doses than traditional therapies?

Guest: Jennifer L. Payne, MD Guest: Melissa Simon, MD Since postpartum depression is a serious medical condition that can negatively impact mothers, infants, and partners, it is important to identify symptoms in a timely manner.1-4 Dr. Jennifer Payne and Dr. Melissa Simon are here to share their clinical experiences screening patients for postpartum depression, explore strategies to overcome common challenges in screening, and identify best practices for collaborating in the care of perinatal women. Dr. Payne is a Professor of Psychiatry and Neurobehavioral Sciences as well as Obstetrics and Gynecology at the University of Virginia, and Dr. Simon is a Professor of Obstetrics and Gynecology at the Northwestern University Feinberg School of Medicine. References American Psychiatric Association. Depressive disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5™. 5th ed. American Psychiatric Publishing; 2013:155-188. Campbell SB, Cohn JF, Meyers T. Depression in First-Time Mothers: Mother-Infant Interaction and Depression Chronicity. Dev Psychol. 1995;31:349-357. Moore Simas TA, Huang MY, Patton C, et al. The humanistic burden of postpartum depression: a systematic literature review. Curr Med Res Opin. 2019;35(3):383-393. Thompson KS, Fox JE. Post-partum depression: a comprehensive approach to evaluation and treatment. Ment Health Fam Med. 2010;7(4):249-257. Sage Therapeutics and the Sage Therapeutics logo …

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 AbbVie 24-hour Parkinson's treatment  The bad — Sage Therapeutics axes workforce  The ugly — FDA halts Novavax's COVID-flu vaccine trials 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sanofi has signed a $326 million deal with Orano Med for radiopharma, following a similar deal made in September. Sage Therapeutics is laying off 33% of employees to support the launch of its postpartum depression drug. Bristol-Myers Squibb's Opdivo showed a progression-free survival advantage over Pfizer's Adcetris in a late-stage study for Hodgkin's lymphoma. Kezar Life Sciences has cut its lupus program after patient deaths and is now focusing on autoimmune hepatitis. The Institute for Clinical Research is researching ways to extend healthy lifespan. Other news includes GSK and Viiv touting the effectiveness of a long-acting HIV prep, Bavarian Nordic's Jynneos eliciting a robust antibody response in adolescents, and AbbVie winning approval for an advanced Parkinson's treatment. Takeda has walked away from a partnership for Huntington's disease after investing $260 million.

Lauren Holder recently did a webinar with HDYO's Jenna Heilman, Prof. Hugh Rickards, and HDYO Ambassador Molly about breaking down barriers when it comes to access to a potential treatment. You can watch the full video here: https://www.youtube.com/watch?v=y6CrrVGfBTk Breaking Down Barriers is sponsored by Roche, Sage Therapeutics, Teva Pharmaceutical, uniQure, Wave Life Sciences, The Griffin Foundation, Neurocrine Biosciences and PTC Therapeutics.

In this CME episode, Dr. Andrew Cutler interviews Dr. Charles Vega about the challenges of identifying bipolar disorder in primary care and how to over come them. They also discuss strategies for initiating and managing pharmacological treatment long term in collaboration with patients and psychiatric specialists. 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 Objective: After completing this educational activity, you should be better able to: Identify the key symptoms and diagnostic criteria for bipolar disorder to accurately screen and diagnose patients presenting in primary care settings Describe strategies for initiating and managing pharmacological treatment of bipolar disorder, including appropriate use of mood stabilizers, antipsychotics, and monitoring for side effects and adherence Explain the role of the primary care provider in coordinating care for bipolar disorder patients, including providing psychoeducation, determining appropriate level of care, and collaborating with mental health specialists when needed Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: 45 minutes Released: September 04, 2024*   Expiration: September 03, 2027 *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/POD24-PrimCare Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI designates this enduring material for a maximum of 0.75 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 NEI designates this Enduring Material for a maximum of 0.75 ANCC contact hour Nurse Practitioner: ACCME AMA PRA Category 1 Credits™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 0.75 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 0.75 contact hour (.075 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 0.75 AAPA Category 1 credit. Approval is valid until September 03, 2027. PAs should only claim credit commensurate with the extent of their participation. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI 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 0.75 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, cognitive disorders — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. Disclosures are from the original live presentation, unless otherwise noted. 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, NYChief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Charles P. Vega, MD Clinical Professor, School of Medicine, University of California - Irvine, Orange, CA Consultant/Advisor: Boehringer Ingelheim, Exact Sciences The remaining Planning Committee member(s), Content Editor(s), Peer Reviewer(s), and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Gabriela Alarcón, PhD, Andrea Zimmerman, EdD, Samantha Joy, and Brielle Calleo. 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 Contact Us: 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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.GSK is relying on its flagship program to help find new drugs and vaccines, following disappointments with Ventyx's tyk2 drug suffering setbacks. New Amsterdam's heart drug hits trial goals but disappoints investors, and Boehringer adds to its cancer drug pipeline with a deal for startup Nerio. The industry is exploring the use of eClinical technology to improve clinical trials, while stakeholders are looking for more efficient ways to innovate with real-world evidence. Overall, the biopharma industry is facing challenges and setbacks, but also opportunities for growth and development in various areas of research and development.Boehringer Ingelheim has acquired Nerio Therapeutics for $1.3 billion in order to strengthen its immuno-oncology pipeline with novel immune checkpoint inhibitors. Additionally, Adaptimmune is preparing for potential approval of their first-in-class engineered T cell therapy. In other news, Wuxi Apptec's U.S. revenue dropped slightly as the Biosecure Act looms, while the FDA has flagged safety risks of compounded versions of Novo Nordisk's semaglutide. AbbVie's Skyrizi has received EU approval for ulcerative colitis, and Merck's Keytruda in combination with Padcev has been granted a positive opinion by CHMP for urothelial carcinoma. Other updates include FDA approvals for new oral Alzheimer's therapy and expanded labels for Grifols' SCIG therapy. The biopharma industry is also experiencing layoffs at companies such as Cue, Anokion, and Glycomimetics. Biogen is facing challenges with its neuro drugs, including a recent EU regulatory rejection for Leqembi due to concerns about brain swelling. The company also had a setback with an essential tremor treatment developed with Sage Therapeutics. Despite these failures, Biogen and Sage will continue to work together as part of a two-drug development deal. The industry is exploring preclinical modeling as a potential solution to improve the success rate of neuro drug development. Overall, Biogen's development pipeline is under pressure, especially following the withdrawal of the Alzheimer's drug Aduhelm earlier in the year. The company is facing obstacles in gaining traction with its treatments in both the US and European markets.Optum is planning to lay off over 500 workers in California, affecting various healthcare facilities and remote workers. CHS posted a $13 million loss in the second quarter, despite increases in surgical and outpatient volumes. Lawmakers are urged to support nursing home staffing regulations to protect the elderly, rather than overturning them. The resumption of the VA Oracle EHR rollout is being questioned at a subcommittee hearing. Healthcare leaders are encouraged to use digital tools to address the shortage of mental health providers and meet the growing need for mental health services. Overall, the healthcare industry is facing challenges related to patient communication, staffing regulations, and financial losses.Support the Show.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CDRH Director Jeff Shuren is set to step down after 15 years, with Michelle Tarver serving as acting director of the FDA's medical devices unit. Boston Scientific predicts strong growth for Farapulse following a successful launch. The top 5 medtech deals in the first half of 2024 include Johnson & Johnson's $13.1 billion takeover of Shockwave Medical. ICU Medical is closing a Minnesota facility and cutting 83 jobs, while Cook Medical plans to sell its reproductive health business to a private equity firm. Medline is exploring an IPO in 2025, Magenta securing $105 million for trials of the world's smallest heart pump, and robotic aid improving balance and gait in children with cerebral palsy.Transitioning to healthcare news, HCA reported $17.5 billion in revenue in the second quarter and raised its full-year guidance. Humana's Centerwell plans to open 23 primary care clinics at Walmart stores. Maternal health quality varies by state, with states with more restrictive abortion bans having fewer maternal health providers and higher maternal death rates. Pharmacy benefit managers, including CVS Caremark, Optum Rx, and Express Scripts, faced scrutiny from Congress over drug pricing policies. AI is being used to transform unstructured patient data into structured reports in healthcare systems.Moving on to updates in pharmaceuticals, Pfizer's hemophilia gene therapy met its late-stage study goal, but questions remain about the long-term potential of hemophilia treatments. Biogen's tremor drug, Sage-324, failed a key trial, and the FDA's medical device chief, Shuren, is stepping down after 15 years. Novartis is investing in bispecifics for cancer, while Autobahn raised $100 million for neuropsych drugs. Bob Langer steps down from Moderna's board, and PBMs are facing bipartisan scrutiny over drug pricing policies.In the biopharma sector, Biogen and Sage Therapeutics have discontinued a phase II trial for an investigational neuroactive steroid for essential tremor after it failed to significantly improve upper limb tremors. Pfizer's gene therapy for hemophilia A has shown positive results in a phase III trial. The FDA has raised concerns about potential overtreatment with AstraZeneca's Imfinzi for resectable non-small cell lung cancer. There is speculation about whether Merck should buy out Moderna to strengthen their partnership on Keytruda-cancer vaccine.Lastly, in marketing news, Google's ad revenue remains strong despite transitions in technology, with AI implementations and cookie changes. Albertsons' retail media business is incorporating AI and in-store technology to improve operations. Coca-Cola and Delta are 'olympicizing' their campaigns with NBCUniversal, as advertisers spend over $1.2 billion for the Olympics. Google has become the official search AI partner of Team USA, leveraging its products for NBCUniversal's Olympics coverage.The marketing landscape is evolving with a focus on technology, data-driven strategies, and partnerships between brands and media companies like NBCUniversal and Google.

Host: Matt Birnholz, MD Guest: Kay Matthews, LCHW Ms. Kay Matthews has lived experience with postpartum depression and now advocates for others as the Executive Director and Founder of Shades of Blue, which is dedicated to breaking cultural barriers in maternal mental health. Tune in to hear her speak with Dr. Matt Birnholz about her journey with postpartum depression, barriers that can prevent or delay patients from seeking care, and strategies for combatting stigma and ensuring a timely diagnosis. Sage Therapeutics and the Sage Therapeutics logo are registered trademarks of Sage Therapeutics, Inc.Sage Therapeutics, Inc. All rights reserved.Sage Therapeutics ©2024 MRC-PPD-00792 06/2024

Host: Matt Birnholz, MD Guest: Kay Matthews, LCHW Ms. Kay Matthews has lived experience with postpartum depression and now advocates for others as the Executive Director and Founder of Shades of Blue, which is dedicated to breaking cultural barriers in maternal mental health. Tune in to hear her speak with Dr. Matt Birnholz about her journey with postpartum depression, barriers that can prevent or delay patients from seeking care, and strategies for combatting stigma and ensuring a timely diagnosis. Sage Therapeutics and the Sage Therapeutics logo are registered trademarks of Sage Therapeutics, Inc.Sage Therapeutics, Inc. All rights reserved.Sage Therapeutics ©2024 MRC-PPD-00792 06/2024

Host: Matt Birnholz, MD Guest: Kay Matthews, LCHW Ms. Kay Matthews has lived experience with postpartum depression and now advocates for others as the Executive Director and Founder of Shades of Blue, which is dedicated to breaking cultural barriers in maternal mental health. Tune in to hear her speak with Dr. Matt Birnholz about her journey with postpartum depression, barriers that can prevent or delay patients from seeking care, and strategies for combatting stigma and ensuring a timely diagnosis. Sage Therapeutics and the Sage Therapeutics logo are registered trademarks of Sage Therapeutics, Inc.Sage Therapeutics, Inc. All rights reserved.Sage Therapeutics ©2024 MRC-PPD-00792 06/2024

Special guest Marshall E. Cates, PharmD, BCPP, FASHP, FCCP, FALSHP, Professor of Pharmacy Practice from the McWhorter School of Pharmacy at Samford University joins us to talk about pharmacotherapy for anxiety and depression.Listen in as we discuss pharmacotherapy for managing generalized anxiety disorder and major depression, with a focus on tailoring first- or second-line options to individual patient needs.You'll also hear practical advice from Craig D. Williams, PharmD, FNLA, BCPS, a member of TRC's Editorial Advisory Board and Clinical Professor of Pharmacy Practice at the Oregon Health and Science University.For the purposes of disclosure, Dr. Cates reports relevant financial relationships [psychiatry] with Biogen, Sage Therapeutics (honorarium); Otsuka (speakers bureau).The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.The clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter and Prescriber Insights: Chart: Pharmacotherapy of Anxiety Disorders in AdultsChart: Choosing and Switching AntidepressantsChart: Combining and Augmenting AntidepressantsIf you're not yet a Pharmacist's Letter or Prescriber Insights subscriber, find out more about our product offerings at trchealthcare.com. Follow or subscribe, rate, and review this show in your favorite podcast app. Find the show on YouTube by searching for ‘TRC Healthcare' or clicking here. You can also reach out to provide feedback or make suggestions by emailing us at ContactUs@trchealthcare.com.

In this CME episode, Dr. Andrew Cutler interviews Dr. Laxman Bahroo about the current landscape of tardive dyskinesia, including screening, diagnosis, and treatment. Practical strategies based on the latest data are reviewed at length, particularly for long-term management of tardive dyskinesia.  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: Consider the individual patient profile and symptoms when determining a treatment plan for patients with tardive dyskinesia Integrate latest safety, efficacy, and tolerability data of VMAT2 inhibitors into decision-making processes when considering treatment options for tardive dyskinesia Evaluate practical strategies for patient follow-up and long-term VMAT2 inhibitor treatment Evaluate and integrate recent updates and advancements regarding evidence-based treatment strategies for tardive dyskinesia Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: June 26, 2024*   Expiration: June 25, 2027 *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/POD24-02-TD Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI designates this enduring material for a maximum of 1.0 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 NEI designates this Enduring Material for a maximum of 1.0 ANCC contact hours Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.0 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.0 contact hour (.10 CEUs). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.0 AAPA Category 1 credit. Approval is valid until June 25, 2027. 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. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, NEI 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 1.0 general continuing education credits. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)™) 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 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, cognitive disorders — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. 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, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Laxman B. Bahroo, DO, MS, FAAN Professor and Residency Program Director, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC Consultant/Advisor: AbbVie, Amneal, Ipsen, Kyowa Kirin, Merz, Neurocrine, Revance, Supernus Speakers Bureau: AbbVie, Acadia, Acorda, Amneal, Ipsen, Kyowa Kirin, Merz, Neurocrine, Supernus, Teva The remaining Planning Committee members, Content Editors, Peer Reviewer, and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Caroline O'Brien, Meghan Grady, Brielle Calleo, and Andrea Zimmerman, EdD. 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 Contact Us: For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported by an unrestricted educational grant from Neurocrine Biosciences.

In this CME episode, Dr. Andrew Cutler interviews Desiree Matthews, PMHNP-BC on the importance of engaging patients across all facets of tardive dyskinesia management beginning with screening to symptoms monitoring to treatment. The role of patient experience and preferences in shared decision-making regarding treatment for tardive dyskinesia is discussed at length.  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: Recognize the significance of comprehensive measures that assess both healthcare practitioner-perceived severity of tardive dyskinesia symptoms and the patient-reported impact of tardive dyskinesia on daily life Engage in informed discussions with patients about the rationale behind incorporating additional medications to manage side effects arising from primary antipsychotic medication Consider all facets of patient health, including physical, mental, and social well-being, when formulating strategies for managing tardive dyskinesia symptoms Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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 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: June 05, 2024*   Expiration: June 04, 2027 *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/POD24-01-TD Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ NEI 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 NEI designates this Enduring Material for a maximum of 1.00 ANCC contact hours Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 0.5 continuing education hour(s) 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(s) (.10 CEUs). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and is unable to report your claimed credit after this 60-day period. Physician Associate/Assistant: AAPA Category 1 CME credits NEI has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit(s) for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.00 AAPA Category 1 credit(s). Approval is valid until June 04, 2027. 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. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, NEI 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 general continuing education credits. Non-Physician Member of the Healthcare Team: Certificate of Participation NEI awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)™) to a participant who successfully completes this educational activity. Peer Review: The content was peer-reviewed by an MD specializing in psychiatry — to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA 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 Desiree M. Matthews, MSN, PMHNP-BC Founder and Clinical Director, Different MHP, PC, Charlotte, NC Consultant/Advisor: Alkermes, Biogen, Boehringer Ingelheim, Karuna, Indivior, Janssen Pharmaceuticals, Neurocrine Biosciences, Sage Therapeutics, Takeda, Teva Speakers Bureau: AbbVie, Axsome, Neurocrine Biosciences, Teva The remaining Planning Committee members, Content Editors, Peer Reviewer, and NEI planners/staff have no financial relationships to disclose. NEI planners and staff include Caroline O'Brien, Meghan Grady, and Andrea Zimmerman. 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 Contact Us: For questions regarding this educational activity, or to cancel your account, please email customerservice@neiglobal.com. Support: This activity is supported by an unrestricted educational grant from Neurocrine Biosciences.

How do today's biotech companies cultivate innovation and harness digital tools for strategic growth? In this episode, we dissect the pivotal role that digital enterprise capabilities play in transforming a company's approach to challenges in the life sciences sector.As I chat with Matt Lasmanis, Chief Technology & Innovation Officer at Sage Therapeutics, we delve into the transformative power of technology within the biotech industry. Matt shares his invaluable insights on strengthening a company's data strategy, investing in AI, and integrating advanced analytics to drive informed decisions. We're exploring the notable shift from the traditional IT department to a model that embodies digital and enterprise capabilities, underlining how crucial this evolution is for a company like Sage. Matt's insights on the cultural shift within the biotech industry and the necessity of a growth mindset promise to be enlightening for leaders and innovators alike.This episode is a must-listen for anyone looking to understand how strategic digital transformation positions a company at the forefront of innovation. Rediscover the potential within the biotech industry by tuning into our engaging conversation.Specifically, this episode highlights the following themes:The strategic implementation of data analytics and AI within Sage TherapeuticsNurturing a culture of innovation within life sciences companiesThe strategic role of cybersecurity and privacy in technology investment decisionsLinks from this episode:Get to know more about Steven Swan: https://www.linkedin.com/in/swangroupGet to know more about Matt Lasmanis: https://www.linkedin.com/in/mattlasmanisLearn more about Sage Therapeutics: https://www.sagerx.com

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA recently approved a biosimilar of Stelara from Alvotech and Teva, set to launch early next year. Johnson & Johnson reported mixed sales performance for new multiple myeloma drugs, with Tecvayli sales exceeding expectations and Carvykti underperforming. Roche also released survival data for a new lymphoma drug, potentially giving it an edge over a competitor. The US government sued Regeneron for allegedly falsely reporting prices on the blockbuster eye drug Eylea. Other topics covered in the newsletter include drug pricing trends, diversity in clinical trials, and the weight loss drug market.In order to successfully execute health advertising campaigns, marketers need to take a proactive approach by targeting health audience segments online. Actionable insights are provided to maximize the impact of media investment through tips such as implementing a test and learn strategy, scaling results quickly, and asking tough questions to potential health targeting partners. Veeva Crossix is highlighted as a company that implements these tactics to reach consumers throughout the patient journey.Abbott CEO Robert Ford highlighted new and upcoming products during an earnings call, emphasizing the recently approved Triclip valve as a significant opportunity for growth. The FDA issued a warning to Soulaire for selling a device outside of authorized uses. Lilly's obesity drug showed benefits in a sleep disorder study, indicating potential new uses. Johnson & Johnson's $30 billion spending spree on companies like Abiomed, Laminar, and Shockwave Medical may continue. Additionally, Philips entered into a consent decree with the FDA, where the agency will use rare powers to require repairs, replacements, or refunds for recalled respiratory machines.Eli Lilly's weight-loss drug Zepbound has shown effectiveness in treating sleep apnea, leading the company to prepare for a label expansion. Amylyx faced a setback with the failure of its ALS drug Relyvrio, leading to layoffs and market withdrawal. Despite this, the company saw success in treating Wolfram syndrome. Sage Therapeutics also announced the discontinuation of its Parkinson's disease program after disappointing results in phase II trials, shifting focus to Huntington's and Alzheimer's diseases.The medical device industry is increasingly incorporating AI and digital health technologies to improve performance and outcomes. Overall, the medtech sector is evolving rapidly with new products and technologies driving growth and innovation.

Jennifer Petrillo Billet PhD is an Executive Director and Program Lead for investigational dalzanemdor, or SAGE-718, at Sage Therapeutics. She is responsible for driving the global development strategy, including delivery of the right evidence for key stakeholders including regulators, payers, and providers, and patients. Dalzanemdor is being evaluated for indications in Huntington's Disease, Alzheimer's Disease, and Cognitive Impairment in Parkinson's Disease. Jennifer has 20 years of deep expertise in the measurement science of Clinical Outcomes Assessments (COAs) and significant experience in all phases of drug development. Jennifer received her Bachelors in Economics at Virginia Tech, and her PhD from the London School of Hygiene and Tropical Medicine (LSHTM). She has published and presented extensively on health economics and outcomes research topics, and clinical research, across a range of leading journals and conferences.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Abingworth has invested in Trodelvy development in a deal with Gilead, where one of the investment firm's startups will work with Gilead to expand the cancer drug's label. Cure Ventures has backed a cell therapy startup called Kenai Therapeutics targeting Parkinson's, with $82 million raised and chaired by Jeff Jonas, a former CEO of Sage Therapeutics. Former Turning Point executives have started a new startup with Blossomhill, focusing on cancer and autoimmune diseases and raising over $170 million in funding. Lindus Health, co-founded by a Moderna co-founder Robert Langer, is aiming to address challenges in contract drug research. Ginkgo has acquired Proof Diagnostics, founded by Feng Zhang, to gain gene editing tools for making genetic medicines.In other news, there is an inside look at biotech financing tools, a theory on protein chirality, settlement agreements in price-fixing cases, and upcoming webinars on omnichannel HCP engagement and tech talent recruitment in the life sciences industry. Biopharma Dive provides insights and news on biotech and pharma trends, covering topics such as clinical trials, FDA approvals, gene therapy, drug pricing, and research partnerships.

In this episode, Chris Benecchi, Chief Business Officer of Sage Therapeutics, joins Hannah McGillivray to discuss how Sage is tackling postpartum depression through the recent oral treatment launched in December '23, Zurzuvae. They chat about addressing the stigma behind PPD, educating providers, partnering with stakeholders, and finding mentors. The Healthcare Community at Kellogg is always looking to collaborate with industry leaders. To learn more about Healthscape or the Kellogg Healthcare Club, please contact Hannah McGillivray.

In this CME episode, Dr. Andrew Cutler interviews Dr. Dani Cabral about current and novel diagnostic tools and treatments for Alzheimer's disease. Optional CE Credits and Certificate Instructions: After listening to the podcast, to take the optional posttest and receive CE credit, click nei.global/POD23-MDD Learning Objectives: After completing this educational activity, you should be better able to: Describe the potential role of multimodal imaging and biomarker strategies in the diagnostic process for Alzheimer's disease Assess the safety and efficacy of novel disease-modifying pharmacological treatments for Alzheimer's disease Describe potential future advancements in the diagnosis and treatment of Alzheimer's disease Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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. NEI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A posttest score of 70% or higher is required to receive CE credit. The content in this activity pertains to pharmacology and is worth 1.0 continuing education hour of pharmacotherapeutics. Credit Types: The following are being offered for this activity: Nurse Practitioner: ANCC contact hours Pharmacy: ACPE application-based contact hours Physician: ACCME AMA PRA Category 1 Credits ™ Physician Associate: AAPA Category 1 CME credits Psychology: APA CE credits Social Work: ASWB-ACE CE credits Non-Physician Member of the Healthcare Team: Certificate of Participation stating the program is designated for AMA PRA Category 1 Credits™ Peer Review: The content was peer-reviewed by an MD specializing in psychiatry to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes responsibility for the content, quality, and scientific integrity of this CE activity. Disclosures: All individuals in a position to influence or control content are required to disclose any relevant financial relationships. Potential conflicts of interest are identified and mitigated prior to the activity being planned, developed, or presented. Interviewer 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, NY Chief Medical Officer, Neuroscience Education Institute, Carlsbad, CA Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cerevel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Neumora, Neurocrine, Noven, Otsuka, Relmada, Sage Therapeutics, Sunovion, Supernus, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alkermes, Axsome, BioXcel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, Supernus, Takeda, Teva, Tris Pharma Interviewee Dani Cabral, MD Assistant Clinical Professor, Departments of Neurology and of Psychiatry, University of Arizona College of Medicine, Phoenix, AZ Dementia Specialist, Banner Sun Health Research Institute, Sun City, AZ Consultant/Advisor: Eisai, Lilly, Roche/Genentech Interview Questions Author Caroline L. O'Brien, MS Assistant Manager, Grant Development, Neuroscience Education Institute, Carlsbad, CA No financial relationships to disclose. The Planning Committee, Content Editor, and Peer Reviewers have no financial relationships to disclose. 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 Competencies 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. Support: This activity is supported by an unrestricted educational grant from Eisai. Released: December 27, 2023      CE credit expires: December 27, 2026

In this CME episode, Dr. Andrew Cutler interviews Dr. Jeffrey Strawn about the role of pharmacogenomic testing in guiding treatment of major depressive disorder (MDD). They discuss how pharmacogenomic testing works, the impact of failed treatments and side effects on patients with MDD, and the clinical applications and future directions of pharmacogenomic testing. Optional 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/POD23-GEN Learning Objectives: After completing this educational activity, you should be better able to: Recognize the role of a patient's genetics in informing the efficacy and tolerability of antidepressants Consider opportunities to use pharmacogenomics as an evidence-based tool that can be employed to inform clinical decision making Implement pharmacogenomic testing to optimize patient outcomes, including symptom improvement, medication response, and remission rate Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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. NEI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A posttest score of 70% or higher is required to receive CME/CE credit. The content in this activity pertains to pharmacology and is worth 1.0 continuing education hour of pharmacotherapeutics. Credit Types: The following are being offered for this activity: Nurse Practitioner: ANCC contact hours Pharmacy: ACPE application-based contact hours Physician: ACCME AMA PRA Category 1 Credits ™ Physician Associate: AAPA Category 1 CME credits Psychology: APA CE credits Social Work: ASWB-ACE CE credits Non-Physician Member of the Healthcare Team: Certificate of Participation stating the program is designated for AMA PRA Category 1 Credits™ Peer Review: The content was peer-reviewed by an MD specializing in psychiatry to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. Potential conflicts of interest are identified and mitigated prior to the activity being planned, developed, or presented. Interviewer Andrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, NY Chief Medical Officer, Neuroscience Education Institute, Carlsbad, CA Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cerevel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Neumora, Neurocrine, Noven, Otsuka, Relmada, Sage Therapeutics, Sunovion, Supernus, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alkermes, Axsome, BioXcel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, Supernus, Takeda, Teva, Tris Pharma Interviewee Jeffrey R. Strawn, MD Professor, Department of Psychiatry and Behavioral Neuroscience and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH Grant/Research: Allergan/AbbVie Consultant/Advisor: Cerevel, Intra-Cellular, Otsuka Pre-Interview Author Gabriela Alarcón, PhD Senior Medical Writer, Neuroscience Education Institute, Carlsbad, CA No financial relationships to disclose. The Planning Committee, Content Editor, and Peer Reviewer have no financial relationships to disclose. 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 Competencies 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. Support: This activity is supported by an unrestricted educational grant from Myriad Genetics. Released: December 13, 2023      CME/CE credit expires: December 13, 2026

In this CME episode, Dr. Andrew Cutler interviews Dr. Vladimir Maletic about the impact of residual symptoms on patients with major depressive disorder, as well as treatment modifications to address residual symptoms in these individuals. Optional 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/POD23-MDD Learning Objectives: After completing this educational activity, you should be better able to: Describe the burden of residual symptoms in patients with major depressive disorder (MDD) Implement measurement-based care to assess residual MDD symptoms Modify treatment strategies to address residual MDD symptoms, including cognitive impairment, anhedonia, emotional blunting, and sexual dysfunction Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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. NEI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A posttest score of 70% or higher is required to receive CME/CE credit. The content in this activity pertains to pharmacology and is worth 1.0 continuing education hour of pharmacotherapeutics. Credit Types: The following are being offered for this activity: Nurse Practitioner: ANCC contact hours Pharmacy: ACPE application-based contact hours Physician: ACCME AMA PRA Category 1 Credits ™ Physician Associate: AAPA Category 1 CME credits Psychology: APA CE credits Social Work: ASWB-ACE CE credits Non-Physician Member of the Healthcare Team: Certificate of Participation stating the program is designated for AMA PRA Category 1 Credits™ Peer Review: The content was peer-reviewed by an MD specializing in psychiatry to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes 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. Potential conflicts of interest are identified and mitigated prior to the activity being planned, developed, or presented. Interviewer Andrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, NY Chief Medical Officer, Neuroscience Education Institute, Carlsbad, CA Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cerevel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Neumora, Neurocrine, Noven, Otsuka, Relmada, Sage Therapeutics, Sunovion, Supernus, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alkermes, Axsome, BioXcel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, Supernus, Takeda, Teva, Tris Pharma Interviewee Vladimir Maletic, MD, MS Clinical Professor, Department of Psychiatry and Behavioral Science, University of South Carolina School of Medicine Greenville, SC Consultant/ Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Biogen/Sage, Boehringer Ingelheim, Cervel, Intra-Cellular, Janssen, Jazz, Lundbeck, Neurelis, Neumora, Noven, Otsuka, Pax Medica, Relmada, Sunovion, Supernus, Takeda Speakers Bureau: AbbVie, Alfasigma, Alkermes, Axsome, Corium, Intracellular, Janssen, Lundbeck, Otsuka, Sunovion, Supernus, Takeda Pre-Interview Author Caroline L. O'Brien, MS Assistant Manager, Grant Development, Neuroscience Education Institute, Carlsbad, CA No financial relationships to disclose. The Planning Committee, Content Editor, and Peer Reviewer have no financial relationships to disclose. 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 Competencies 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. Support: This activity is supported by an unrestricted educational grant from Takeda. Released: November 29, 2023      CME/CE credit expires: November 29, 2026

Texas is getting hotter. Beat the heat Healthy Adult Popsicle  - 1 part alcohol to 5 parts non-alcohol. Rum, Coconut milk, frozen berries Can't grow tomatoes in this heat… corn is growing well! Joe Biden… is he too old to get the job done?  Actor  Comedian Paul Rueben's best known for his character Pee Wee Herman passed away.   The incandescent light bulb ban https://apple.news/AGgIpbksbQnKVkiwK5jpPgw Former Lizzo dancers were weight-shamed and pressured while at strip club, lawsuit says https://apple.news/A3zUMYeUgQECTQrSt1cNtT Nine men rob Gucci in Century City in latest brazen daytime attack on the brand https://apple.news/APFM1I3WVSLCI5DkBcZSKcw  FDA approves first postpartum depression pill in the US https://www.cnn.com/2023/08/04/health/fda-approves-first-postpartum-depression-pill-in-the-us Zurzuvae, is designed to be taken once a day for two weeks after pregnancy—a much shorter period than currently deployed treatments, such as antidepressants or talk therapy, that are not specific to postpartum depression. Zurzuvae was developed by Sage Therapeutics when Indio freezes over and the trip from hell - Amie  Support the OTDM Podcast by shopping with our affiliates: ⁠INSTACART⁠... Enjoy every moment of summer with free delivery on first 3 orders. Get cookout ingredients, picnic snacks, & more. Min $10+ req/order.  Now - 9/10 ⁠⁠https://instacart.pxf.io/c/2856585/1731530/7412⁠⁠ ⁠PURE SPECTRUM CBD⁠... Sean finds PAIN RELIEF for his arthritis (hallux rigidus). Over the past year, the pain has become somewhat debilitating and in an effort to ease the pain, he is using CBD oil from Pure Spectrum. Sean's morning routine: I dropper of Pure Spectrum Black Label. Use the discount code   OTDM    for 15% Off All your CBD needs @ ⁠⁠https://www.purespectrumcbd.com/⁠⁠ ⁠AMAZON⁠... Do you buy stuff from Amazon? Visit Amazon through our link and any purchases you make (even if it's not in our store) will count towards the Podcast. How cool is that? Simply use Amazon how you normally would but go to it through our link...  ⁠⁠https://www.amazon.com/shop/katimorton⁠⁠ CONNECT Discord community https://discord.gg/4gPTrGBM9z OTDM census form https://forms.gle/qFZM3ywPzrpKMkKfA Email OTDMpod@gmail.com Speakpipe 90 second voice message: https://www.speakpipe.com/OTDM Kati Morton TikTok @Katimorton Instagram @katimorton Sean St. Louis TikTok @hatori_seanzo Instagram @seansaintlouis This description contains affiliate links, and we may be compensated if you make a purchase after clicking on my links.   --- Send in a voice message: https://podcasters.spotify.com/pod/show/otdm/message Support this podcast: https://podcasters.spotify.com/pod/show/otdm/support