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ST. LOUIS, Mo.--( BUSINESS WIRE )-- Optime Care , a member of the AscellaHealth Family of Companies , today announced a contractual partnership with Rigel Pharmaceuticals, Inc., bringing its full suite patient support/HUB service capabilities to support Rezlidhia™(olutasidenib), a recent FDA-approved treatment for adult patients with relapse or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Optime Care’s services for life sciences manufacturers include pre-commercialization and market access expertise, exclusive distribution partnerships, national medication fulfillment and high-touch patient support and HUB services for enhanced patient outcomes. Brandon Salke, general manager and pharmacist-in-charge, says, “Our dedicated team of highly experienced nurse navigators and case managers looks forward to implementing a custom, branded program for Rigel Pharmaceuticals, enabling Rezlidhia™ patients to experience optimal therapeutic outcomes and the best possible treatment journey.” Rigel Pharmaceuticals, Inc. has a long-standing relationship with Optime Care and has selected them for the management of Rezlidhia™ patients based upon its rare disease expertise and comprehensive suite of integrated patient management and HUB services including distribution, patient intake, prescription fulfillment, prior authorization support, custom clinical programs, reimbursement services and financial assistance. Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, “We are excited to work with Optime Care in the complete management of our Rezlidhia™ patients. Optime Care’s patient-first and collaborative approach to patient management of rare disease patients enables us to take advantage of their comprehensive expertise and knowledge which are critical to ensuring that Rezlidhia™ patients receive the best care possible for an optimal treatment journey and enhanced clinical outcomes.” About REZLIDHIA™ INDICATION REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. IMPORTANT SAFETY INFORMATION WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, Kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution. WARNINGS AND PRECAUTIONS Differentiation Syndrome REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence. Hepatotoxicity REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin. Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity. ADVERSE REACTIONS The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis. DRUG INTERACTIONS Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers. Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs. LACTATION Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose. GERIATRIC USE No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase inincidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age. HEPATIC IMPAIRMENT In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome. Click here for Full Prescribing Information, including Boxed WARNING. To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088). REZLIDHIA is a trademark of Rigel Pharmaceuticals, Inc. About Optime Care Optime Care, Inc. is a nationally recognized specialty pharmacy, distribution and patient management organization offering a suite of comprehensive services tailored to maximize the therapeutic opportunities for the treatment of orphan and rare disorders. Our executive team has partnered in the launch and management of over 40 orphan products and programs while consistently implementing the best brand services for the community. Our experience with small patient populations, coupled with our strategic partnership with AscellaHealth , enhances our services and ability to serve the specialty pharmacy market. Optime Care has dual-accreditation from the Utilization Review Accreditation Commission (URAC) for compliance with specialty pharmacy and the Accreditation Commission for Health Care (ACHC) for specialty pharmacy services that demonstrate a commitment to providing quality care and services to consumers. https://www.optimecare.com/ About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer, and rare immune diseases. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com .

New guidelines include updates to recommendations around obesity, hypertension, heart failure medication, social determinants of health, and lipid management ARLINGTON, Va., Dec. 12, 2022 /PRNewswire/ -- Today, the American Diabetes Association® (ADA) published Standards of Care in Diabetes—2023 (Standards of Care), comprehensive, evidence-based guidelines for the prevention, diagnosis, and treatment of diabetes. Based on the latest scientific research and clinical trials, the Standards of Care includes vital new and updated practice guidelines to care for people with diabetes and prediabetes, including for the diagnosis and treatment of youth and adults with type 1, type 2, or gestational diabetes; strategies for the prevention or delay of type 2 diabetes and associated comorbidities; and therapeutic approaches that can reduce complications, mitigate cardiovascular and renal risk, and improve health outcomes. "ADA's mission is to prevent and cure diabetes, a chronic illness that requires continuous medical care, and the release of ADA's Standards of Care is a critical part of that mission," said Chuck Henderson, chief executive officer for the ADA. "This year's annual report provides necessary guidance that considers the role health inequities play in the development of diabetes, particularly for vulnerable communities and communities of color disproportionately impacted by the disease. This guidance will ensure health care teams, clinicians and researchers treat the whole person." Notable updates to the Standards of Care in Diabetes─2023 include: Emphasis on supporting higher weight loss (up to 15%) based on the efficacy of and access to newer medications when appropriate New recommendations related to sleep health and physical activity in people with diabetes Broad consideration of social determinants of health in guiding the design and delivery of care New hypertension diagnosis cut-offs (hypertension is now defined as a systolic blood pressure ≥130 mmHg or a diastolic blood pressure ≥80 mmHg) The expanded role of SGLT2 inhibitor use in preserved and reduced heart failure ejection fraction The role of finerenone in individuals with diabetes and chronic kidney disease with albuminuria New lipid management recommendations suggesting lower LDL goals for high-risk individuals "Evidence-based recommendations drive better care for all people with diabetes, including vulnerable communities and those at high risk. ADA's Standards of Care are the gold standard for diabetes care and prevention that allows clinicians around the world to remain abreast of the rapidly changing healthcare landscape," said Dr. Robert Gabbay, chief scientific and medical officer for the ADA. Other noteworthy changes to the 2023 Standards of Care include: Details on digital health, telehealth, and telemedicine and the benefits of these modalities of care delivery The utility of point-of-care A1C testing for diabetes screening and diagnosis An expanded " Nonalcoholic Fatty Liver Disease" (NAFLD) subsection Screening for food insecurity by any member of the diabetes healthcare team Updates in alignment with the Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) The use of technology in older adults with diabetes The use of person-first and inclusive language Updates in vaccination for people with diabetes Updates in COVID-19 and diabetes The Standards of Care are reviewed and updated annually by the ADA's Professional Practice Committee (PPC). "The field of diabetes is changing fast. ADA's Standards of Care strives to provide up-to-date guidance using the best available evidence rigorously and comprehensively," said Nuha ElSayed, MD, MMSc, PPC chair. The committee is a multidisciplinary team of 20 leading U.S. experts in the field of diabetes care and includes physicians, nurse practitioners, certified diabetes care and education specialists, registered dietitians, pharmacists, methodologists, and others with experience in adult and pediatric endocrinology, epidemiology, public health, cardiovascular risk management, microvascular complications, preconception and pregnancy care, weight management, diabetes prevention, behavioral and mental health, inpatient care, and use of technology in diabetes management. Two designated representatives of the American College of Cardiology (ACC) participated in the subcommittee on the "Cardiovascular Disease and Risk Management" section. This section received endorsement from the ACC for the sixth consecutive year. New this year, the ADA garnered the expertise of specialized subject matter experts by adding them as committee members to the subsections on neuropathy, retinopathy, foot care, and non-alcoholic fatty liver disease. Today, the Standards of Care in Diabetes—2023 is available online and is published as a supplement to the January 2023 issue of Diabetes Care®. The online version will be annotated in real-time with necessary updates if new evidence or regulatory changes merit immediate incorporation through the "living" Standards of Care process. The ADA fosters broad dissemination through a shortened version of the guidelines, known as the Abridged Standards of Care, for primary care providers in its journal Clinical Diabetes® and offers a convenient Standards of Care app as well as a Standards of Care pocket chart. Other Standards of Care resources, including a webcast with continuing education credit and a full slide deck, can be found on the ADA's professional website, DiabetesPro®. About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 82 years, the ADA has driven discovery and research to treat, manage, and prevent diabetes while working relentlessly for a cure. Through advocacy, program development, and education we aim to improve the quality of life for the over 133 million Americans living with diabetes or prediabetes. Diabetes has brought us together, what we do next will make us Connected for Life®. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), Twitter (@AmDiabetesAssn), and Instagram (@AmDiabetesAssn). Contact: Rebecca Fisher, (703) 253-4918 [email protected] SOURCE American Diabetes Association

SAN FRANCISCO--( BUSINESS WIRE )--In response to the mental health epidemic, Brightside Health today announced Crisis Care , a first-of-its-kind national telehealth program for treating individuals with elevated suicide risk. Brightside Health delivers life-changing mental health care to individuals with mild-to-severe clinical depression, anxiety, and other mood disorders. With the addition of Crisis Care, the company will expand its services to individuals experiencing acute suicidal thoughts and behaviors. According to the CDC, 130 Americans die every day by suicide – about one death every 11 minutes. Over the course of a year, more than 12 million people seriously consider suicide, 3.2 million make a plan, and 1.2 million people attempt suicide. The suicide crisis has been building for over 20 years, and with a growing provider shortage and a shrinking number of clinicians willing to risk treating high-severity and acuity patients, it’s getting worse. While telehealth has improved access to mental health care, the majority of virtual mental health services only treat patients with low-to-moderately severe conditions. This critical gap in care leaves lives at risk and increases healthcare costs due to avoidable ER visits and hospitalizations. Crisis Care was developed to fill this widening gap, providing timely access to specialized care for individuals with acute suicide risk. “Simply put, we built Crisis Care to save lives,” said Brad Kittredge, CEO and co-founder of Brightside Health. “We have a responsibility to do more for this vulnerable population, and it's critical to our mission of delivering life-changing mental health care to everyone who needs it. We look forward to helping as many people as possible.” Based on the clinically-proven Collaborative Assessment and Management of Suicidality (CAMS) framework, Crisis Care is available to patients who are actively suicidal and/or have had a recent suicide attempt, as well as those in need of follow-up care after hospitalization. The high-touch, tech-enabled (4-12 week) program is staffed by a select group of CAMS-trained clinicians and includes 1:1 weekly video sessions, online check-ins, anytime messaging, and 24/7 call support. It also employs a structured, collaborative approach with documented in-session assessments, treatment planning, and safety plans. Crisis Care ensures safety and efficacy through the use of research-backed clinical protocols, rigorous oversight, and care coordination if the patient requires a higher level of treatment or is ready to step down to routine services. “Patients with active suicide risk are often seen in settings where they cannot access the right kind of care,” said Mimi Winsberg, MD, Chief Medical Officer and co-founder of Brightside Health. “With Crisis Care, patients are quickly connected with CAMS-trained clinicians to get the most appropriate care. In doing so, we will change how our healthcare system operates and begin to reverse the staggering national statistics on suicide.” To date, Brightside Health’s proven care model has demonstrated significant treatment response in patients presenting with severe symptoms and passive thoughts of suicide. Upon entering care, 75% of patients have severe or moderately severe depression, 71% need help with three or more conditions, and 47% are experiencing suicidal ideation. Across the entire patient population, 86% experience clinically significant improvement within 12 weeks, and 71% achieve remission. Furthermore, a study published in JMIR Formative Research determined participants receiving care through Brightside Health’s telehealth platform were 4.3 times more likely to experience remission of suicidal ideation than the control group, with 77% experiencing elimination of suicidal ideation within 12 weeks. Crisis Care is the natural progression for the organization as it aims to meet the unmet demand from individuals with elevated suicide risk. Clinicians will apply the same level of clinical rigor and expertise in treating this high-need population and will save lives with the support of key referral partners like NeuroFlow, a behavioral health platform that specializes in identifying and triaging individuals to the right level of care. “Demand for behavioral healthcare has never been more acute, and we have an opportunity and responsibility to connect people who are suffering with the right resources,” said Tom Zaubler, MD, MPH and Chief Medical Officer of NeuroFlow . “We're excited to support strategic initiatives from our partners like Crisis Care from Brightside Health and fundamentally believe in the life-saving work it will achieve.” Crisis Care is available effective immediately in select states, with a full national roll out coming soon. To learn more about Crisis Care, including how to access the program, visit www.brightside.com/crisis-care . To learn more about Brightside Health, visit www.brightside.com . About Brightside Health Brightside Health delivers life-changing mental health care to people with mild to severe clinical depression, anxiety, and other mood disorders, including those with elevated suicide risk. Powered by proprietary AI, purpose-built technology, and a world-class clinician network, Brightside combines precision psychiatry and leading-edge therapeutic techniques to improve patient outcomes across the entire clinical spectrum, affordably and at scale. Brightside Health can be paid for with insurance in all 50 states and DC, with appointments available in 48 hours or less. Learn more at www.brightside.com . About NeuroFlow NeuroFlow integrates behavioral health across the care continuum by assessing and triaging people to get them to the right level of care, providing high-tech and high-touch support for populations that would typically fall through the cracks in today’s healthcare system. Proven to drive better clinical and financial outcomes for leading health systems, payors, and the Department of Defense covering 15 million lives, NeuroFlow’s platform combines consumer engagement with enterprise-level care management software and clinical support services to support integrated behavioral health at scale. To learn more, visit www.neuroflow.com .