Kaposi Sarcoma

STOCKHOLM, Sweden, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX) (“Calliditas”), today announced upcoming presence and data presentations at the American Society of Nephrology Kidney Week 2024 in San Diego, California on October 23 – 27, 2024. Presentations will highlight an open-label extension study of the efficacy and safety of Nefecon (TARPEYO® (budesonide) delayed release capsules)) in patients with primary immunoglobulin A nephropathy (IgAN), results from a real-world case series of IgAN patients, and additional insights from biomarker analysis. “We look forward to attending ASN Kidney Week and sharing additional data that reinforce Nefecon as a cornerstone treatment in IgAN,” said Richard Philipson, Chief Medical Officer at Calliditas. "This conference offers a great opportunity to exchange scientific knowledge with leading experts in nephrology and contribute to discussions around innovative treatments, including our potentially disease-modifying option." The oral presentation and poster presentation details are below. Following the meeting, they will be available on the Presentations and Publications page on Calliditas’ corporate website. Oral Presentation Details: Title: “NeflgArd Open-Label Extension: Efficacy and Safety of Nefecon in Patients with IgAN Who Completed the 2-Year Phase 3 Trial”Date and Time: October 25, 2024 from 4:40 PM to 4:50 PM PTLocation: Room 6D, Convention Center Poster Presentation Details: Title: “Results from a real-world case series of IgAN patients who received at least 9 months of Tarpeyo”Date and Time:Location: October 25, 2024 from 10:00 AM to 12:00 PM PT Title: Specificity of Nefecon in Targeting Pathogenic IgA in IgA Nephropathy While Preserving Systemic Humoral ImmunityDate and Time: October 25, 2024 from 10:00 AM to 12:00 PM PT Title: Impact of Nefecon on Complement Pathways in IgA Nephropathy: An Analysis of Lectin, Alternative, and Terminal PathwaysDate and Time: October 25, 2024 from 10:00 AM to 12:00 PM PT For more information, visit booth 1920 or visit the ASN Kidney Week 2024 website here. INDICATION TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations. WARNINGS AND PRECAUTIONSHypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Immunosuppression and Increased Risk of Infection: Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed. Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, measles). Corticosteroid therapy may decrease the immune response to some vaccines. Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects. ADVERSE REACTIONS In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). DRUG INTERACTIONS Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide. USE IN SPECIFIC POPULATIONSPregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information. About TARPEYOTARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. About Primary Immunoglobulin A NephropathyPrimary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. For further information, please contact:Emma Santosegsantos@lifescicomms.com The information was sent for publication, through the agency of the contact persons set out above, on October 16, 2024, at 14.00 p.m. CET.

THURSDAY, Aug. 1, 2024 -- Cancer rates are rising among Gen Xers and millennials, a new study reports. Successively younger generations are more frequently being diagnosed half of the 34 known cancer types, researchers found. For example, people born in 1990 have two to three times higher rates of pancreatic, kidney and small intestinal cancer than people born in 1955, results show. “These findings add to growing evidence of increased cancer risk in post-Baby Boomer generations, expanding on previous findings of early-onset colorectal cancer and a few obesity-associated cancers to encompass a broader range of cancer types,” said lead researcher Hyuna Sung , a senior principal scientist of surveillance and health equity science at the American Cancer Society. For the study, researchers analyzed cancer data from 23.6 million patients diagnosed between 2000 and 2019. The analysis also included data on 7.3 million patients who died of cancer. Researchers broke the data down into five-year birth intervals from 1920 to 1990, and analyzed how cancer risk changed between birth cohorts. Incidence rates increased with each successive birth cohort since 1920 for 17 of 34 cancers, researchers found. Other cancers that have increased in younger generations include liver, breast, uterine, colorectal, gastric, gallbladder, ovarian, testicular and anal cancers, as well as Kaposi sarcoma, results show. “The increase in cancer rates among this younger group of people indicate generational shifts in cancer risk and often serve as an early indicator of future cancer burden in the country,” said senior researcher Dr. Ahmedin Jemal , senior vice president of surveillance and health equity science at the American Cancer Society. Cancer death rates increased in successively younger generations for liver, uterine, gallbladder, testicular and colorectal cancer, results show. Unfortunately, Sung said there’s no clear explanation for why these rates are rising among younger generations. “The data highlights the critical need to identify and address underlying risk factors in Gen X and Millennial populations to inform prevention strategies,” Jemal said. The results, published July 31 in the Lancet Public Health journal, also highlight the need for comprehensive health care among middle-aged and younger Americans, said Lisa Lacasse , president of the American Cancer Society Cancer Action Network (ACS CAN). "The increasing cancer burden among younger generations underscores the importance of ensuring people of all ages have access to affordable, comprehensive health insurance, a key factor in cancer outcomes," Lacasse said in cancer society news release. "To that end, ACS CAN will continue our longstanding work to urge lawmakers to expand Medicaid in states that have yet to do so, as well as continue to advocate for making permanent the enhanced Affordable Care Act tax subsidies that have opened the door to access to care for millions,” Lacasse added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

EAST WINDSOR, N.J., July 23, 2024 /PRNewswire/ -- ForDoz Pharma Corp., a private specialty pharmaceutical company focused on product development, manufacturing and commercialization of complex injectables, like liposomes, microspheres, nano-suspensions, etc., today announced the ANDA approval of DOXOrubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) from the United States Food and Drug Administration (US FDA). DOXOrubicin Hydrochloride Liposome Injection is indicated for the treatment of patients with ovarian cancer and AIDS-related Kaposi's sarcoma. Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma. "The approval of DOXOrubicin Hydrochloride Liposome Injection marks a major milestone for ForDoz Pharma as our 1st liposomal injectable pharmaceutical product to enter the US market. It will be distributed by Lupin Pharmaceuticals, Inc.," said James He, Founder and CEO of ForDoz Pharma. About ForDoz Pharma Corp. ForDoz Pharma Corporation is a privately-owned specialty pharmaceutical company focusing on development, manufacturing, and commercialization of value-added sterile and complex injectable products. Based on its proprietary technology platform and unique cGMP sterile manufacturing facility, the company's corporate strategy is to accelerate the development and manufacturing of complex injectables for its own and help others through CDMO service. Please visit for more information LinkedIn: Media Contact: James He, CEO 609-469-5949 SOURCE ForDoz Pharma Corp.