Erythroderma

Mallinckrodt Presents Data on Real-World Outcomes with THERAKOS™ CELLEX™ Photopheresis System Treatment at the 2024 Tandem Meetings

Retrieved on: 
Wednesday, February 21, 2024
Thermal, Bangladesh Technical Education Board, Pulmonary embolism, Hypotension, Mallinckrodt, Anemia, Month, NIH, PUVA, Meta-analysis, Erythroderma, Excipient, Safety, PUVA therapy, Pain, Infection, Quality of life (healthcare), Deep vein thrombosis, Photopheresis, Artifact, FFS, ECP, Risk, OS, Graft-versus-host disease, Society, Extracorporeal, Methoxsalen, Patient, Systematic review, Burns, Transplant, Massachusetts General Hospital, Sunlight, Literature, Clutch (eggs), Environment, Pharmaceutical industry

DUBLIN, Feb. 21, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation of findings from a systematic literature review and meta-analysis of the safety, efficacy, and real-world outcomes of extracorporeal photopheresis (ECP) treatment for patients with steroid-refractory chronic graft-versus-host disease (SR-cGvHD).1 An analysis of 47 studies reporting on the THERAKOS™ CELLEX™ Photopheresis System showed that treatment of SR-cGvHD with ECP was associated with improvements in patients' overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).1 The results will be shared in a poster presentation at the 2024 Tandem Meetings, the combined Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) taking place February 21-24, 2024 in San Antonio, TX.

Key Points: 
  • Skin-specific response at Months 2-3 and at Months 4-6 were 34.86% (95% CI: 13.26-65.21) and 54.22% (95% CI: 35.67-71.67), respectively.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to THERAKOS ECP.
  • THERAKOS™ Photopheresis is contraindicated in:
    THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available.
  • Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions and adverse events.

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Friday, February 2, 2024
Partnership, Conjunctivitis, Medicine, Inflammation, Vitamin, Thrombocytopenia, Immune system, Tyrosine, Patient, Light, Nosebleed, Intellectual disability, Itch, Ageing, Diet, Keratitis, Skin, Pharmacy, Tongue, Rash, DSM-IV codes, Allergy, Blood, Leukopenia, Photophobia, Mouth ulcer, Phenylalanine, Erythroderma, Tell, Insurance, Face, Breast milk, Plasma, Nursing

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

New Post Hoc Analysis from MAVORIC Trial Sheds Light on the Burden of Cutaneous T-Cell Lymphoma on Health-Related Quality of Life

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Well, Mycosis fungoides, Organ, Neuropsychological test, CTCL, Cutaneous T-cell lymphoma, Central Statistics Office (India), Disease, Skin, Eastern Cooperative Oncology Group, Modified, Patient, Itch, Bivariate, Lymph, KKI, Neoplasm, Blood, ECOG, Cancer, ANOVA, Erythroderma, Female, Quality of life, Children's Oncology Group, Nursing, Medical imaging

Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • In multivariate analysis, worse HRQL was associated with being younger, female, moderate or severe pruritus and impaired function (as measured by ECOG PS).

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Monday, December 11, 2023
Urine, Reproduction, Skeleton, Headache, PSA, Kidney, Erythroderma, Patient, Pharmacy, Birth, Nephrotic syndrome, MBA, Cancer, Miscarriage, Safety, Incidence, VTE, Bevacizumab, Corneal opacity, Wound healing, VEGFR2, Gastrointestinal perforation, Hemoptysis, Female, Fetus, CHF, Celltrion, Pharming, Necrotizing fasciitis, Heart failure, Fistula, Risk, Tracheoesophageal fistula, Bleeding, Organogenesis, Partnership, Rhinitis, Hypertension, Primary ovarian insufficiency, Back pain, Pregnancy, Glioblastoma, PRES, Nosebleed, Skull, FDA, ATE, VEGF, MBM, Hypertensive encephalopathy, Toxicity, Nursing, Pharmaceutical industry, Birth control, Dietary supplement, Proteinuria

Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.

New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Retrieved on: 
Monday, December 11, 2023
Well, American Society of Hematology, Mycosis fungoides, Organ, Neuropsychological test, CTCL, Cutaneous T-cell lymphoma, Central Statistics Office (India), Disease, Skin, Eastern Cooperative Oncology Group, Modified, Patient, Itch, Bivariate, Lymph, Neoplasm, TSE, Blood, ECOG, Cancer, ANOVA, Erythroderma, Society, Female, Quality of life, Children's Oncology Group, Kyowa Kirin, B-cell lymphoma

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

Retrieved on: 
Wednesday, October 4, 2023
Insurance, Cornea, Keratitis, US Foods, Tyrosine, Diet, Medicine, Tell, Face, Chapter 11, Title 11, United States Code, Erythroderma, Skin, Light, DSM-IV codes, Inflammation, Carglumic acid, Mouth ulcer, Rash, Phenylalanine, Intellectual disability, Eton, Plasma, Vitamin, Hair, Photophobia, Allergy, Patient, Leukopenia, Blood, Itch, Immune system, Cover My Eyes (Pain and Heaven), Ageing, Rare, FDA, Conjunctivitis, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, Tongue, Food, Breast milk, Pharmaceutical industry, Nursing, Dietary supplement, Medical imaging, Birth control, Nitisinone

DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. Food and Drug Administration (FDA) in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition.

Key Points: 
  • Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025.
  • Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients.
  • Nitisinone is a prescription medicine used to treat adults and children with a hereditary disease called tyrosinemia type 1 (HT-1).
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients

Retrieved on: 
Wednesday, September 7, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Fatigue, UC, Hepatotoxicity, Liver, Pfizer, Pleural effusion, Thyroiditis, Grade 3, Maintenance, Hypothyroidism, TEN, Breathe Me, PD-1, Grade 2, Photophobia, Pulmonary embolism, PD-L1, Nausea, Patient, Avelumab, Field line, Stevens–Johnson syndrome, Incidence, Eosinophilia, Pneumonitis, Headache, Insulin, FDA, Diabetes, Hyperthyroidism, Creatinine, Diarrhea, Hyperglycemia, Kidney, Erythroderma, Pneumonia, AST, Hepatitis, Colitis, Rash, Hypophysitis, MCC, Lists of diseases, Fourth grade, Endocrinology, Hypopituitarism, Dermatitis, Degenerative disease, Prednisone, Neoplasm, HIV disease progression rates, RCC, DRESS, Brain Quest Grades 3 & 4, SJS, Infection, ALT, Edema, Merck Group, Drug, Adrenal insufficiency, Diabetic ketoacidosis, Vaccine, Pharmaceutical industry, Cytomegalovirus, Angela Merkel

Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Key Points: 
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • Immune-mediated pneumonitis occurred in 1.2% (21/1738) of patients, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (0.3%) and Grade 2 (0.6%) adverse reactions.
  • Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including Grade 3 (0.4%) and Grade 2 (0.7%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 0.5% (8/1738) of patients, including Grade 3 (0.1%) and Grade 2 (0.3%) adverse reactions.

Kyowa Kirin International: New Real World Evidence Underlines Benefits of POTELIGEO®▼ (mogamulizumab) Treatment for Cutaneous T-cell Lymphoma (CTCL) Patients

Retrieved on: 
Thursday, October 14, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Product, Incidence, Roger Hawkins (drummer), Lymphocytopenia, Degenerative disease, Kyowa Hakko Kirin, Asia, Neurology, FDA, Disease, Itch, Sleep, Lymph, Research, MF, Weakness, Non-Hodgkin lymphoma, Blood, B-cell lymphoma, Engineering, Cutaneous T cell lymphoma, Medication package insert, T-cell lymphoma, Patient, Life, CC, Lymphocyte, Family, Saint Louis Hospital (Bangkok), ORR, Diagnosis, Dermatitis, Erythroderma, Vorinostat, Skin, SS, Histone deacetylase inhibitor, Kirin, Pain, Adult, Rash, NHL, CCR4, Malignancy, Mycosis fungoides, Nephrology, Hair loss, EORTC, Hospital, Safety, Pharmaceutical industry, Vaccine, Medical imaging, Mycosis Fungoides (MF) and Sézary syndrome (SS), POTELIGEO, Kyowa Kirin, MYCOSIS FUNGOIDES (MF) AND SéZARY SYNDROME (SS), POTELIGEO, KYOWA KIRIN

Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced a new study of real world data showing higher response rates than previously seen in people living with cutaneous T-cell lymphoma (CTCL) treated with POTELIGEO (mogamulizumab).

Key Points: 
  • Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced a new study of real world data showing higher response rates than previously seen in people living with cutaneous T-cell lymphoma (CTCL) treated with POTELIGEO (mogamulizumab).
  • The best overall response rate (ORR) seen in the real-life study was 47.0% in MF patients and 68.3% in SS patients.
  • In contrast, the ORRb in MAVORIC was 21% and 37%, respectively.1,2 Of the 124 patients who received POTELIGEO treatment in the study, 44% were MF patients and 56% were SS patients.
  • Its heartening to see this new real world data, which reinforces what weve seen previously in clinical trials.

EMD Serono to Present Latest Highlights From Oncology Portfolio at WCLC and ESMO 2021

Retrieved on: 
Sunday, September 12, 2021
Managed Care, Research, Radiology, Pharmaceutical, Oncology, Hospitals, Clinical Trials, Science, Biotechnology, Nursing, FDA, Health, Other Science, BAVENCIO® (avelumab), Tepotinib, Berzosertib, Bintrafusp Alfa, EMD Serono, Inc., Merck KGaA, Darmstadt, Germany, BAVENCIO® (AVELUMAB), TEPOTINIB, BERZOSERTIB, BINTRAFUSP ALFA, EMD SERONO, INC., MERCK KGAA, DARMSTADT, GERMANY

EMD Serono is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer.

Key Points: 
  • EMD Serono is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer.
  • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.