Peripheral edema

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

WhiteSwell Announces Six-month Outcomes After eLym System Treatment for Acute Decompensated Heart Failure Patients in its DELTA-HF Study

Retrieved on: 
Wednesday, March 6, 2024
Medical Devices, Health, Surgery, Clinical Trials, Cardiology, Biotechnology, Peripheral edema, Thoracic duct, Acute decompensated heart failure, Ohio State University, Physiology, Drainage, Congestion, Heart failure, ADHF, Cell biology, Death, Patient, Lymphatic system, Medicine, THT, Tissue, Pharmaceutical industry

WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.

Key Points: 
  • WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.
  • Nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy and were followed for six months.
  • Reduced rehospitalizations: Comparing patients’ clinical course before and after eLym therapy, in the six months prior to eLym therapy there were 13 heart failure related hospitalizations, while in the six months after eLym therapy there were just two heart failure hospitalizations and one heart failure related death, for a 77% reduction.
  • The minimally invasive catheter system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours.

Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

Retrieved on: 
Wednesday, February 14, 2024
Investigational New Drug, Peripheral edema, Anemia, Gastroenteritis, Medicine, Periodic breathing, Leukopenia, Diarrhea, Quality of life, Cough, Dizziness, Deep vein thrombosis, Nausea, Vomiting, DVT, Common, Tremor, Back pain, Constipation, Safety, Dexamethasone, First grade, Lower respiratory tract infection, URTI, Bronchitis, Therapy, Fatigue, Bortezomib, Pharmacokinetics, Thrombocytopenia, Rash, Patient, Neutropenia, Acceleration, Multiple myeloma, RMOC, IND, Insomnia, Lenalidomide, Appetite, Abdominal pain, Weakness, Pharmaceutical industry

The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).

Key Points: 
  • The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).
  • Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024.
  • I’m excited about the potential opportunity STAR-LLD can bring to multiple myeloma patients.”
    Earlier last month, Starton disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.
  • Notably, no hematologic toxicities greater than Grade 1 have been observed following up to 3 cycles of treatment thus far.

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, January 3, 2024
Quality of life, Leukopenia, URTI, Constipation, Lower respiratory tract infection, IND, Insomnia, CD8, Diarrhea, PD-1, DVT, Anemia, Gastroenteritis, Tremor, Fatigue, Common, CD4, Nausea, Multiple myeloma, Neutropenia, Abdominal pain, Therapy, Lenalidomide, Pharmacokinetics, Weakness, Dizziness, Thrombocytopenia, Cytotoxic T cell, Dexamethasone, Appetite, Periodic breathing, Bortezomib, Toxicity, Back pain, Patient, Safety, Peripheral edema, Deep vein thrombosis, Vomiting, Cough, Rash, Bronchitis

Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.

Key Points: 
  • Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
  • Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date.
  • Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks.
  • Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects.

ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH

Retrieved on: 
Sunday, December 10, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Molecular Pharmacology, Fever, Associate, Azacitidine, Hypotension, Safety, CCR, Spacecraft, Pneumonia, ASH, University, Cytopenia, Disease, Cellular, Constipation, Fatigue, Mortality, Penile ultrasonography, Patient, IMGN, DNA, MRD, Medical Affairs Bureau, Pharmacokinetics, Peripheral edema, Flow cytometry, Capillary leak syndrome, MD, Diarrhea, Cancer, Nausea, Survival, Drug resistance, Transplant, AML, Apoptosis, MD Anderson Cancer Center, Society, ImmunoGen, Hypokalemia, Hypophosphatemia, Venetoclax, Rare-earth element, Pharmaceutical industry, Birth control, Vaccine, Medicinal plants, Research

These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.

Key Points: 
  • These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.
  • “The MRD negativity rates, which are indicative of a deep remission, are particularly promising in the treated patient population.
  • Response rates and MRD negativity were numerically comparable between cohorts 1 and 2, despite differences in the venetoclax schedule.
  • We look forward to continuing to expand our cohort of newly diagnosed unfit patients to inform the development path for pivekimab in AML.”
    ImmunoGen is also presenting two preclinical posters at ASH.

Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules

Retrieved on: 
Friday, December 1, 2023
FDA, Health, General Health, Research, Pharmaceutical, Science, Diet, DSM-IV codes, EPA, NYSE, Business development, Organization, 1G, Constipation, Patient, Atrial fibrillation, Peripheral edema, Partnership, Eicosapentaenoic acid, Medication, Gout, Hypertriglyceridemia, Stride, Ethyl eicosapentaenoic acid

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®.
  • The product has been in-licensed from Strides, a global pharmaceutical manufacturer, and will be commercialized by Amneal starting in the fourth quarter of 2023.
  • Icosapent ethyl acid soft gel capsules 0.5g and 1g is an ethyl ester of eicosapentaenoic acid (EPA) that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
  • “The launch of Icosapent ethyl is another essential medicine that we’ve added to our portfolio.”
    “We are thrilled to announce our partnership with Amneal Pharmaceuticals for Icosapent ethyl acid soft gelatin capsules.

NeuroMetrix Reports Q3 2023 Business Highlights

Retrieved on: 
Thursday, October 26, 2023
Dentistry, MA, FDA, Growth, Peripheral edema, PIN, Medicare, Financial result, Quell, Telephone, Fibromyalgia, Quality of life, Q3, Disease, Prescription, COVID, Clinical trial, Risk, CIPN, Partnership, National Fibromyalgia Association, Center for Medicare and Medicaid Innovation, DSM-IV codes, University, Patient, Centers for Medicare & Medicaid Services, CMS, Peripheral neuropathy, Pharmaceutical industry, Cryptocurrency

WOBURN, Mass., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported business and financial highlights for the quarter and nine month period ended September 30, 2023.

Key Points: 
  • WOBURN, Mass., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported business and financial highlights for the quarter and nine month period ended September 30, 2023.
  • Financial results in Q3 2023 were consistent with Company expectations and reflect the substantial changes to Medicare Advantage risk-adjustment reimbursement implemented by CMS in Q1 2023.
  • Revenue in Q3 2023 of $1.2 million was lower by $0.8 million or 39% from Q3 2022 primarily due to reduced sales volume for DPNCheck.
  • The Q3 2023 net loss was $1.8 million ($0.21 per share) versus a net loss of $1.6 million ($0.23 per share) in Q3 2022.

ABION Presents New Efficacy Data for ABN401, a Novel MET TKI for Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Friday, October 13, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Male, KRAS, KOSDAQ, Vomiting, NSCLC, Peripheral edema, AACR, Cancer, EGFR, Safety, SAE, Lung cancer, Mutation, Diarrhea, Nausea, Smokers v Non-Smokers, Therapy, Smoker, Patient, Progression-free survival, Conference, MET, Pharmaceutical industry

Patients were dosed 800 mg QD and the median duration of response was 5.4 months as of the data cut-off on July 25, 2023.

Key Points: 
  • Patients were dosed 800 mg QD and the median duration of response was 5.4 months as of the data cut-off on July 25, 2023.
  • The data are not mature enough to measure progression-free survival and duration of response.
  • Overall efficacy was comparable to currently marketed drugs and demonstrate superior efficacy in treatment-naïve patients.
  • The cut-off data reaffirm ABN401’s excellent safety profile as shown in an earlier Phase 1 trial.