Fasciitis

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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-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone paymentsTHE WOODLANDS, Texas, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Viatris Inc. (Nasdaq: VTRS) has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the United States and Europe in all indications. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the United States and Europe. Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. “We are pleased to be working with Viatris, a company with strong cardiometabolic expertise, global commercial capabilities and a successful track record of launching medicines in new territories. We are confident that this agreement will expand the reach of sotagliflozin to more patients in need,” said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Partnering with high quality companies to support commercialization of our medicines globally is a critical pillar of our Lead to Succeed strategy at Lexicon. We plan to continue to evaluate strategic partnerships for additional assets, territories and indications to augment Lexicon’s development and commercial capabilities, advance our pipeline and expand access of our medicines to more patients around the world.” Viatris chief commercial officer Corinne Le Goff said: “This licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future. We believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin. We look forward to working with Lexicon to make a real difference and expand access for patients.” Under the terms of the agreement, Viatris has acquired rights to sotagliflozin in all global markets outside of the U.S. and Europe in exchange for an upfront payment to Lexicon of $25 million, and the potential for contingent regulatory and sales milestone payments and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin to Viatris at an agreed upon transfer price. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon is commercially launching one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. About ViatrisViatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, Viatris provides access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases. With its exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with Viatris on LinkedIn, Instagram, YouTube and X (formerly Twitter). About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. INDICATION INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:  heart failure or  type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors  IMPORTANT SAFETY INFORMATION  Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA.  INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.  Contraindications: INPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components.  Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM).  Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors.  The risk of ketoacidosis may be greater with higher doses.  There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors.  Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis.  Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.  INPEFA is not indicated for glycemic control.  Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level.  If suspected, discontinue INPEFA, evaluate, and treat promptly.  Monitor patients for resolution of ketoacidosis before restarting INPEFA.  Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine.  There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors.  Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.  Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.  Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections.  Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.  Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia.  INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue.  Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors.  Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.  Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.  Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections.  Monitor and treat as appropriate.  Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors.  Use alternative testing methods to monitor glucose levels.   Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.  Drug Interactions:  Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.   Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.  Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.  Use in Specific Populations:  Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.  Geriatric Use: No INPEFA dosage change is recommended based on age.  No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.  Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR < 60 mL/min/1.73 m2.  The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile.  There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR < 30 mL/min/1.73m2 relative to the overall safety population.  Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis.  After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment. Click here for full Prescribing Information. https://www.lexpharma.com/inpefa-US-PI.pdf Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin (in other indications), LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media and Investor Inquiries: Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

Phase II trial assessing the efficacy of RECCE® 327 topical gel (R327G) against acute bacterial skin and skin structure infectionsR327G demonstrating promising antibacterial effect across a broad range of human infectionsClinical study review board on track for mid-October, with interim results to followTrial study locations expand across New South Wales (NSW) and Victoria, broadening access to this potentially novel approach SYDNEY, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd., (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed 15 patients in a Phase II trial evaluating RECCE® 327 topical gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI). ABSSSI includes diabetic foot infections (DFI) and other wound infections – areas of significant unmet medical need. “We are thrilled to pass the halfway point of this pivotal Phase II study for the unmet clinical need of topical skin infections. Indications of promising antibacterial effect are significant achievements, with patient recruitment to be completed within the year,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “The market for ABSSSI is expanding due to an increase in the frequency of bacterial skin infections, particularly those brought on by drug-resistant strains. The acute lack of effective broad-spectrum antimicrobials contributes significantly to this challenge. With our initial data from the Therapeutic Goods Administrations (TGA) Special Access Scheme, which saw dramatic results in several DFI patients, we are excited to complete this trial and the potential of R327G to impact this growing global healthcare need.” R327G has been shown to be safe and well tolerated across subjects, indicating promising antibacterial responses in patients. These initial data represent a significant opportunity to expand the application of R327G’s formulation. ABSSSIs are a significant healthcare concern, with clinical trials addressing indications such as DFIs, necrotizing fasciitis, and post-operative wound infections. The global ABSSSI market size was estimated to be $1.34 billion in 2023 and is expected to reach $2.31 billion in the next 10 years. The Phase II trial is an open-label, pilot efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 as a topical gel for ABSSSIs, designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. The study is on track to enroll 30 participants by the end of 2024. In addition to the lead site, Barwon Health, the Company has added two new sites with the Australian Clinical Research Network NSW and ACRN Melbourne. About Recce Pharmaceuticals LtdRecce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics. The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development. Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies. Corporate ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com