Cardiomyopathies

HOUSTON, Oct. 30, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Steven Lorch is acknowledged as a Pinnacle Life Member for his contributions to the field of Pediatric Cardiology. Dr. Lorch attended Emory University in Atlanta where he received a Bachelor of Science degree. He earned a medical degree from Emory University, School of Medicine; completed a residency in pediatrics at Baylor College of Medicine/Texas Children's Hospital; a fellowship in pediatric cardiology at Washington University/St. Louis Children's Hospital. Board-certified in pediatric cardiology, Dr. Lorch explained that as a pediatric cardiologist, he sees infants, young children, and adolescents on an outpatient basis. He treats children for cardiac abnormalities, heart murmurs, tachycardia, and palpitations and works closely with the families and parents of these children, educating them on their conditions. A proven professional, Dr. Lorch specializes in caring for fetuses, infants, children and adolescents with cardiovascular or cardiac abnormalities. He is experienced in both inpatient and outpatient settings and explained that the scope of conditions cared for by pediatric cardiologists is large and includes congenital heart defects; heart muscle disorders; rhythm disturbances; and hypertension. He said that pediatric cardiology is a medical specialty that involves the evaluation, diagnosis, and treatment of congenital (present at birth) and acquired cardiovascular (heart and blood vessel) problems of the fetus, infant, child, adolescent, and young adults. Pediatric cardiologists, like Dr. Lorch, diagnose and treat children with heart conditions before they are born; through childhood; and into adulthood. His clinical interests include pediatric and congenital heart disease, fetal echocardiography, and preventive cardiology. Dedicated to professional networking and staying abreast of the latest innovations in his field, Dr. Lorch is affiliated with Woman's Hospital of Texas; Memorial Hermann Memorial City Medical Center; Memorial Hermann Katy Hospital; Memorial Hermann Northeast Hospital; Memorial Hermann Sugar Land Hospital; and St. Joseph Health College Station Hospital. Prior to his post at Pediatrix Cardiology of Houston, Dr. Lorch served as assistant head of the Pediatric Echocardiography Laboratory at the University of Texas Health Science Center in Houston. He is a Diplomate of the American Board of Pediatrics (ABP) and explained that the mission of the ABP is to advance child health by certifying pediatricians who meet standards of excellence and are committed to continuous learning and improvement. The doctor is a member of the American Society of Echocardiography; American College of Cardiology; Harris County Medical Society; Texas Medical Association. When considering his success, Dr. Lorch notes that his mentors include Achiau Ludomirsky, MD who was his mentor and division director in St. Louis. Aside from his professional pursuits, Dr. Lorch is a parent volunteer with the Boy Scouts of America Troop 55 in Houston. He has been married to Mrs. Clare Gentry for 22 years and they have one son and daughter. For more information about Dr. Lorch's practice, please visit his website at . Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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Bayer obtains global license to develop and commercialize disease-modifying treatment specifically for dilated cardiomyopathy (DCM) patients characterized by specific mutationsPost-licensing, companies will continue to collaborate on cardiovascular and renal programsDewpoint will receive an upfront and additional development and commercial milestone payments amounting to an estimated $424 million, excluding royalties BERLIN and BOSTON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Bayer has entered into an exclusive licensing agreement with Dewpoint Therapeutics, Inc. for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. This is the first option exercise under the research collaboration between Bayer and Dewpoint Therapeutics, Inc., which began in November 2019.It leverages Dewpoint’s proprietary platform for biomolecular condensates and Bayer’s small molecule R&D capabilities to develop new treatments for cardiovascular and renal diseases. “One of the biggest challenges in drug discovery lies in tackling the undruggable human proteome,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. “The emerging paradigm of biomolecular condensates is expanding the traditional drug target space for small molecules by unveiling new targets and new approaches to previously intractable targets. We are excited to be part of this new wave of innovation together with Dewpoint Therapeutics as it is our ambition to provide transformative medicines to cardiovascular patients with the highest unmet needs.” Dilated cardiomyopathy (DCM) is a heart muscle disease where the ventricles enlarge and struggle to pump blood effectively. The licensed program focuses on an innovative method to address a specific form of DCM linked to mutations that lead to the formation of disease-associated condensates. This form of DCM is a severe condition with significant unmet medical needs, characterized by early onset heart failure and frequent life-threatening arrhythmias. “We are excited about the novel discoveries made possible by our collaboration with Bayer, which have immense potential to transform the treatment of DCM,” said Ameet Nathwani, CEO of Dewpoint Therapeutics. “The licensing of the first discovery program underscores the scientific validation of our proprietary condensate-based approach, which identifies and targets the underlying condensate drivers of complex diseases. The pre-clinical findings in this program suggest that a condensate-modifying small molecule can reverse the fundamental disease process. We are delighted that Bayer has exercised its option to license this exciting program which will further strengthen our ongoing collaboration to explore innovative treatments for cardiovascular and renal diseases.” Dewpoint Therapeutics will receive an upfront and additional development and commercial milestone payments amounting to an estimated $424 million, excluding royalties. The ongoing collaboration follows Bayer's participation in Dewpoint's January 2019 Series A financing round through Leaps by Bayer, the strategic investment unit of Bayer. About Condensates Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, and neurological disorders. Condensate-modifying drugs (c-mods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. About Dewpoint Therapeutics Dewpoint is the leading biotech company in the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. The realization that a vast range of conditions are regulated by or arise from the dysfunction of condensates has provided new possibilities for modulating the function of high-value targets previously deemed ‘undruggable,’ opening unexplored avenues to identify hundreds of novel therapeutic targets. Dewpoint’s proprietary AI/ML-powered state-of-the-art platform underlies a drug discovery pipeline that spans multiple therapeutic areas, including oncology, neurodegenerative, cardiopulmonary, and metabolic diseases. Through collaborations with Bayer, Novo Nordisk, and Evotec, Dewpoint pushes the boundaries to accelerate the translation of condensate biology into medicine for patients suffering from difficult-to-treat diseases. Learn more at Dewpointx.com. About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com. Bayer Media Contact:Malena Johannes, phone +49 173 5470379Email: malena.johannes@bayer.com Dewpoint Media Contact: Email: media@dewpointx.com Dewpoint Investor Contact: Michael Fenn, Ph.D.Email: mfenn@dewpointx.com Find more information at https://pharma.bayer.com/Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.