Sleep Wake Disorders

Takeda Pharmaceutical, Japan's largest drugmaker, reported second-quarter earnings on Thursday that beat market expectations. The company also raised its full-year earnings forecast. Takeda is currently undergoing a restructuring plan aimed at cutting costs and improving efficiency. Takeda posted an operating profit of 184.2 billion yen ($1.21 billion) in the three months through September, compared with a loss of 49.3 billion yen a year earlier, when the company was in the red. According to a survey of four analysts by LSEG, Takeda's results far exceeded the consensus forecast of 93.6 billion yen in earnings. Based on the strong first-half performance and an update to currency assumptions, Takeda raised its full-year operating profit forecast to 265 billion yen from 225 billion yen. In May, Takeda announced it would restructure to improve margins and refocus on drug discovery. The company plans to cut or reposition about 1,200 employees at centers in San Diego and Massachusetts, according to domestic media reports, and last week unveiled an early retirement plan for employees in Japan. While Takeda declined to give details on the specific positions affected, the company told Reuters that the restructuring was aimed at "maximizing the potential of our therapeutic portfolio, product lines and organizational structure for long-term growth." Takeda is trying to rebuild its drug pipeline. Last year, the company suffered failures in clinical trials for lung cancer and Crohn's disease treatments, leading to large impairment losses. However, the company has high hopes for its experimental narcolepsy treatment TAK-861 and psoriasis candidates. The drugs were acquired by Takeda from Us-Based Nimbus Therapeutics in late 2022 for up to $6 billion. While Takeda's shares are up 5.2% this year, that still underperforms the benchmark Nikkei average's 17% gain.

LOS ANGELES, Oct. 30, 2024 /PRNewswire/ -- Dr. Scott McMahon of Whole World Health Care is happy to announce the launch of the MEDICINE AND MIRACLES podcast during the month of October, recognized as Health Literacy Month, an international observance where many health organizations work together to promote health literacy awareness. The podcast, hosted by Dr. McMahon, will integrate medical expertise with spiritual healing, offering a unique look at health and recovery through a faith-based perspective. Each episode will delve into inspiring stories, healing practices, and transformative journeys. Dr. McMahon hopes to create a supportive community that embraces positivity, fosters personal growth and give listeners a sense of hope. Continue Reading MEDICINE AND MIRACLES, hosted by Dr. Scott McMahon, will integrate medical expertise with spiritual healing, offering a unique look at health and recovery through a faith-based perspective. Many of the episodes will address the mystery of Chronic Inflammatory Response Syndrome (CIRS), triggered by mold illness and exposure, which debilitates the health of millions each year. Dr. McMahon is a pediatrician and medical expert, specializing in the field of CIRS in kids and adults. He's considered one of the top CIRS pediatric expert across the country, and one of the top CIRS specialists in the world. "Chronic Inflammatory Response Syndrome (CIRS) is still a mystery to the medical community. Each year, millions of people are misdiagnosed and suffer from a multitude of symptoms, caused by mold illness and exposure," said Dr. McMahon. "I hope the MEDICINE AND MIRACLES podcast will offer listeners some accessible, bite-sized information about the condition; spark some 'aha moments' about their own health; and lead them down a road of healing and recovery." Dr. McMahon added he wants to give listeners, who may be dealing with a chronic health issue, a sense of hope because "miracles still happen every single day!" he said. CIRS is a multisystem illness affecting many areas of the body. Every year, mold exposure affects the health of millions of Americans – kids, teens and adults -- with symptoms that include chronic fatigue and pain, watery eyes, headaches, respiratory issues, brain fog, irritability and sleep problems – just to name a few. Oftentimes, these symptoms can lead to patients being misdiagnosed for other disorders like lupus, rheumatoid arthritis, Sjogren's syndrome, chronic fatigue syndrome, IBS, fibromyalgia, multiple sclerosis (MS), chronic regional pain syndrome and many other illnesses. For more information about CIRS, visit CIRSx.com. Throughout the year, Dr. McMahon speaks on mold-related health concerns and CIRS at many statewide, national and international medical conventions and meetings. Throughout his career, he's evaluated approximately 2,000 patients for CIRS from 48 states and 21 countries. And when he's not working with patients, he's also a medical expert in court cases nationwide for mold-related lawsuits. MEDICINE AND MIRACLES can be found on digital platforms, including Spotify, iHeart Radio and Amazon Podcast. JUST DROPPED!! THE MEDICINE AND MIRACLE PODCAST Now on Spotify: Now on iHeartRadio: Now on Amazon Podcasts: ABOUT SCOTT MCMAHON | pediatrician, medical expert and author Dr. Scott McMahon is a pediatrician, author and medical expert, specializing in the field of Chronic Inflammatory Response Syndrome (CIRS), in kids and adults. He is the author of several books, including "The Art and Science of CIRS Medicine," co-written with Dr. Ritchie Shoemaker and Dr. Andrew Heyman, which addresses mold illness. He's also authored or co-authored more than a dozen scientific papers on mold illness and contributed to a couple of medical textbooks. He's one of the leading voices on advancing the science to treat, educate and serve those suffering with CIRS. And when he's not working with patients, he serves as a medical expert in courts across the country, participating in "mold litigation" for plaintiff and the defense cases. He's recognized as a qualified CIRS medical expert for the judicial system in ten states in the United States as well as Quebec, Canada. He's been involved in more than 100 disability, workers compensation and personal injury cases, testifying in ten states as well as Canada, England and soon in the Bahamas. He received his bachelor's degree in chemistry from Creighton University, located in Omaha, Nebraska, in 1985 and completed his medical degree at Creighton University School of Medicine in 1989. Dr. McMahon went on to finish a prestigious pediatric residency at Duke University Medical Center in Durham, North Carolina in 1992. He has maintained board certification since 1992 and practiced pediatrics in Roswell, New Mexico, for more than 30 years. Four years ago, he retired from active pediatric practice; but continues to serve as a pediatric hospitalist. Dr. McMahon currently resides in Roswell, New Mexico with his wife, Mary, and their eight children. He's also an ordained minister through Joan Hunter Ministries. For more about Dr. McMahon and the podcast, visit MedicineAndMiracles.co. SOURCE Dr. Scott McMahon of Whole World Health Care WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Evidence demonstrates that SUBLOCADE supports long-term recovery from opioid use disorder (OUD) and is effective and safe. Publications highlight the importance of overcoming access barriers to long-acting injectable treatments for OUD RICHMOND, Va., Oct. 30, 2024 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV), in recognizing Substance Abuse Prevention Month, provides an update on key findings from the last year that demonstrate the importance of access to medications for the treatment of opioid use disorder (MOUD) and the effectiveness and safety of SUBLOCADE® in the treatment of OUD. These data add to the growing body of evidence that SUBLOCADE can improve outcomes, such as abstinence, retention, and recovery in persons with OUD. Publications In a post hoc analysis of the SUBLOCADE randomized, double-blind, placebo-controlled phase 3 clinical trial, published in Harm Reduction Journal, SUBLOCADE 300 mg maintenance dose resulted in a statistically significant increase in abstinence from opioids among study participants with OUD who injected opioids compared to 100 mg maintenance dose. However, both were equally effective in non-injecting participants. Results from the Community Long-Acting Buprenorphine (CoLAB) Study, a prospective single-arm, multicenter, open label trial in Australia, were published in the International Journal of Drug Policy, and demonstrated that participants could be maintained on SUBLOCADE treatment for 96 weeks with continuous improvements in abstinence, depression, quality of life and medication satisfaction. In a qualitative research survey of 20 participants representing various practice settings, published in American Health & Drug Benefits, it was determined that telemedicine was the most common solution adopted during the COVID-19 pandemic to overcome access barriers. However, today there are still significant challenges in ensuring appropriate access to medications for those living with OUD and continued support, effective solutions and policies in the United States, need to be continually addressed. In a narrowly focused literature, policy, and legal proceedings review, published in Corrections Today, a clear disparity in access to MOUD was found between the general public and incarcerated individuals. Stigma and informed consent were the most discussed barriers used to justify policies limiting MOUD for incarcerated individuals. Presentations Multiple real-world evidence poster presentations highlight challenges and opportunities in treating persons with OUD. 2024 American Association of Psychiatric Pharmacists, April 7-10, Orlando FL Title: Emergency Room (ER) Visits Among Opioid Use Disorder (OUD) Patients Title: Opioid Treatment Programs, Healthcare Resource Utilization, and Healthcare Costs among Patients Initiating Treatment with Buprenorphine Extended-Release 2024 American Telemedicine Association Nexus, May 5-7, Phoenix AZ Title: Impact of Telemedicine on Medication for Opioid Use Disorder Retention during the SARS-CoV-2 Pandemic Period Among Patients with OUD 2024 College on Problems of Drug Dependence, June 15-19, Montreal Quebec Canada Title: Buprenorphine Treatment After an Emergency Department Visit for Non-Fatal Opioid Overdose Title: Pain Predicts Abstinence During Treatment of Opioid Use Disorder for Individuals Reporting Moderate to Severe Pain Title: A Randomized Open-Label Study Comparing Rapid and Standard Inductions to Injectable Buprenorphine Extended-Release (BUP-XR) Treatment Title: A Mechanistic Pharmacological Model to Predict and Inform Effective Buprenorphine Treatment Induction Strategies in the Era of Synthetic Opioids 2024 U.S. Public Health Service Scientific & Training Symposium, June 24-27, Jacksonville FL Title: Clinical and Treatment Characteristics of American Indian/Alaska Native Patients Managing Opioid Use Disorder Compared to the General US Population BUPE2024 – Buprenorphine in Medicine: Clinical and Public Policy Implications, August 5, Virtual conference Title: Healthcare Utilization and Costs Associated with Management of Opioid Use Disorder (OUD) within Residential Treatment Programs (RTP) and Office-Based Opioid Treatment Programs (OBOT) 2024 National Commission on Correctional Health Care (NCCHC) Annual, October 19-23, Las Vegas, NV Title: Outcomes Associated with Medications for Opioid Use Disorder in the Carceral System: A Systematic Literature Review Title: Diversion of Medications for OUD in the Criminal Justice System Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior, emphasized, "The collective evidence highlights the importance of access to Medications for OUD, such as SUBLOCADE, in reducing barriers to adherence and improving outcomes for individuals in recovery. Indivior is committed to continuing to advance the understanding of patients with OUD, educate on evidence-based practices, overcome stigma, and focus on recovery outcomes." Among the almost 6 million people aged 12 or older with a past year opioid use disorder in 2023, only 18% (or one million people) received treatment through MOUD.1 About SUBLOCADE® SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of Indivior's proprietary buprenorphine gel depot delivery system. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs. Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed. Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid. Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit . About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences.2 OUD may affect the parts of the brain that are necessary for life-sustaining functions.2,3 About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting . References Substance Abuse and Mental Health Services Administration. (2024). Key substance use and mental health indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (HHS Publication No. PEP24-07-021, NSDUH Series H-59). Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (samhsa.gov) National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Medication-Assisted Treatment for Opioid Use Disorder, Mancher, M., & Leshner, A. I. (Eds.). (2019). Medications for Opioid Use Disorder Save Lives. National Academies Press (US). Accessed October 30, 2023, from NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED