Hyperlipidemia

Click Therapeutics Accelerates Expansion into Obesity and Cardiometabolic Disease With Acquisition of the Assets of Better Therapeutics, Inc.

Retrieved on: 
onsdag, maj 22, 2024
Technology, Medical Devices, Diabetes, Cardiology, Software, Other Health, Biotechnology, Pharmaceutical, Health, Artificial Intelligence, Blood pressure, Neuro, LDL, Patient, MASH, Hyperlipidemia, Obesity, FDA, Therapy, Digital, Disease, Migraine, Opioid use disorder, Boehringer Ingelheim, Hypertension, Psychiatry, Research, CNS, Acquisition, DSM-IV codes, Environment, Schizophrenia, Psychology, Pharmaceutical industry

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced plans to accelerate its development initiatives in obesity and cardiometabolic disease through the acquisition of the assets of Better Therapeutics, Inc.

Key Points: 
  • Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced plans to accelerate its development initiatives in obesity and cardiometabolic disease through the acquisition of the assets of Better Therapeutics, Inc.
  • This acquisition strengthens Click’s portfolio of innovative digital treatments for patients by immediately advancing its pipeline in obesity, diabetes and cardiometabolic diseases, complementing existing assets in psychiatry, CNS and pain disorders.
  • Click’s advancement into obesity and cardiometabolic disease is a culmination of progress over the past few years including the initiation of CT-181, a prescription digital therapeutic candidate for obesity.
  • “There is immense potential in the cardiometabolic space for next-generation ‘smart’ therapeutics that enhance patient care and provider capabilities,” said Rich DeNunzio, Chief Commercial Officer of Click Therapeutics.

Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024

Retrieved on: 
tisdag, maj 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Blood pressure, Diabetes, Patient, Steroid, Hyperlipidemia, Kidney disease, ICER, National Kidney Foundation, Disease, QALY, Glucocorticoid, Cyclophosphamide, MMF, Safety, Physician, Proteinuria, Lupus nephritis, CNI, NKF, Pharmaceutical industry

Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN).

Key Points: 
  • Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN).
  • An updated cost-effectiveness analysis demonstrated that LUPKYNIS continues to be a cost-effective treatment for lupus nephritis (LN).
  • Cost-effectiveness was assessed with the ICER AnalyticsTM LN model and the majority of model assumptions from the original analysis were consistent with the 2021 analysis.
  • “People living with lupus nephritis must be able to access clinically meaningful treatment options to manage the severity of the disease.

Neurocrine Biosciences Presents CAHtalyst™ Adult Study Baseline Characteristics and Data on Impact of Supraphysiologic Glucocorticoid Therapy at AACE 2024

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torsdag, maj 9, 2024
Disorder, Common, Risk, GC, Overweight, Trial of the century, Adrenocorticotropic hormone, Hyperlipidemia, Associate, Deficit spending, Hydrocortisone, Neurocrine Biosciences, White matter, Food, Oklahoma State University–Stillwater, Cognition, Psychology, Testosterone, Male, Literature, Brain, DSM-IV codes, A4, SAN, GCS, CAH, Acne, Safety, Glucocorticoid, Research, Depression, Congenital adrenal hyperplasia, Osteopenia, Anxiety, Division, Hirsutism, Androstenedione, Psychiatry, Psychosis, Hypertension, Metabolism, Poster, Pharmaceutical industry

The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.

Key Points: 
  • The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.
  • These new data were presented at oral presentations and poster sessions at the American Association of Clinical Endocrinology 2024 Annual Meeting in New Orleans.
  • Despite supraphysiologic GC dosing, levels of adrenocorticotropic hormone, 17-hydroxyprogesterone and androstenedione (A4) were elevated at baseline, with levels of testosterone (females) and A4/testosterone (males) also elevated.
  • The data from both studies supported two New Drug Applications submitted to the U.S. Food and Drug Administration in April 2024.

Alcanza Strengthens Midwest Presence with Acquisition of Kansas City Research Institute

Retrieved on: 
onsdag, maj 1, 2024
Hyperlipidemia, Acquisition, KCRI, Obesity, Health, Type 2 diabetes, Gastroenterology, Patient, Liver, DSM-IV codes, Nursing

ORLANDO, Fla., May 1, 2024 /PRNewswire/ -- Alcanza Clinical Research, a mission-focused investigator site network, announces the acquisition of Kansas City Research Institute (KCRI), a Phase II-IV clinical research site based in Kansas City, MO, with therapeutic specializations focused in gastroenterology, gastrointestinal oncology, hepatology, and a host of metabolic diseases (metabolic associated steatohepatitis [MASH], obesity, type 2 diabetes, hyperlipidemia).

Key Points: 
  • ORLANDO, Fla., May 1, 2024 /PRNewswire/ -- Alcanza Clinical Research, a mission-focused investigator site network, announces the acquisition of Kansas City Research Institute (KCRI), a Phase II-IV clinical research site based in Kansas City, MO, with therapeutic specializations focused in gastroenterology, gastrointestinal oncology, hepatology, and a host of metabolic diseases (metabolic associated steatohepatitis [MASH], obesity, type 2 diabetes, hyperlipidemia).
  • "KCRI's specialty in liver and metabolic diseases, coupled with a track record of enrolling diverse patient populations strengthens the geographic and therapeutic breadth of the Alcanza site network."
  • "Joining Alcanza will ensure KCRI continues delivering on this commitment for the long-term future, as clinical research conduct increasingly requires sophisticated technology infrastructures, advanced operational management, and micro-targeted digital outreach.
  • We look forward to advancing the burgeoning research pipeline while providing the Kansas City metropolitan area with access to novel treatments."

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

Retrieved on: 
måndag, april 15, 2024
FDA, Pain, Mortality, Nephrology, Inflammation, Monocyte, Cell, Anemia, Alternative complement pathway, Safety, Ophthalmology, Red blood cell, Food, Hematology, Chelsea Handler, Dermatology, Half-life, Atypical hemolytic uremic syndrome, Blood, AP, Hyperlipidemia, Hemoglobinuria, Disease, Patient, Neurology, Fatigue, Platelet, Diagnosis, Infection, Hemolysis, Immune system, PNH, ODD, Quality of life, Chronic pain, LDH, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

Response Pharmaceuticals’ Drug Candidate for the Treatment of Antipsychotic-Induced Weight Gain (AIWG) Achieves Primary Endpoint in Phase 1b Clinical Trial

Retrieved on: 
tisdag, april 23, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Fitness & Nutrition, Clinical Trials, Hyperglycemia, Weight gain, Safety, Bipolar disorder, DSM-IV codes, Neuroscience, MD, Human, Depression, Life, Triglyceride, Schizophrenia, Hyperlipidemia, Obesity, Psychiatry, Patient, Olanzapine, Harvard Medical School, AUC, Medication, Quality of life, Pharmaceutical industry

“Antipsychotic medications are essential treatments that help millions of patients live better lives, but can be associated with rapid weight gain and obesity.

Key Points: 
  • “Antipsychotic medications are essential treatments that help millions of patients live better lives, but can be associated with rapid weight gain and obesity.
  • Subjects in the RDX-002 cohort met the primary endpoint for efficacy, lowering postprandial triglycerides (ppTGs).
  • While exploratory, these findings support results seen in other trials where RDX-002 has demonstrated an impact on body weight, hyperlipidemia and hyperglycemia.
  • “Treatment with the iMTP-inhibitor RDX-002 significantly reduced ppTGs and blunted the weight gain in OLAN-treated subjects indicating a potential role in the treatment and prevention of AIWG.

Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response

Retrieved on: 
fredag, mars 22, 2024
Nephrotoxicity, Urinary tract infection, Fungal infection, Culture, Ventilator-associated pneumonia, Burns, Internal medicine, Amphotericin B, Emphysema, Azole, Coronary artery disease, Debridement, Carcinoma, Risk, Hyperlipidemia, Patient, Lung, LNC, Fusarium, Female, Malignancy, University, Doctor of Philosophy, MD, Aspergillosis, Echinocandin, Fever, Immune system, Division, Hypertension, Voriconazole, Physician, Infection, Pharmaceutical industry

The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.

Key Points: 
  • The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.
  • She was transitioned to oral MAT2203 for two weeks, which led to clinical resolution of her fungal infection.
  • She began to show clinical improvement following two weeks of oral MAT2203 treatment and her skin wounds completely healed following six months of MAT2203 treatment.
  • “MAT2203 continues to demonstrate its potential to effectively treat invasive fungal infections and help patients achieve complete clinical resolution.

Innovating "Treadmill Exercise Test AI-Assisted Interpretation System," CMUH(Taiwan) Timely Saves More Patients with Severe Myocardial Infarction

Retrieved on: 
tisdag, april 2, 2024
Depression, Thrombosis, Myocardial infarction, Sudden death, Cardiovascular disease, Exercise, Survival, Coronary artery disease, ECG, Hyperlipidemia, Patient, Palpitations, Angina, Cancer, AI, Death, Moyamoya disease, Chronic pain, Plaque, Diet, Receiver, Smoking, Cardiac catheterization, Stenosis, Oxygen, Heart, Atherosclerosis, Rupture, Ministry, Duke, Vascular occlusion, CAD

To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.

Key Points: 
  • To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.
  • The program also utilizes ten measured features and two derived features including maximal work output and peak heart rate to determine the severity of coronary artery stenosis.
  • Generally, coronary heart disease in patients of middle or senior age is presented as angina or myocardial infarction and is one of the primary causes of sudden death."
  • Dr. Wu stated, "Coronary artery stenosis is a multi-factorial condition related to smoking, advanced age, diabetes hypertension and hyperlipidemia.

Molecular Templates, Inc. Provides Interim Update

Retrieved on: 
måndag, mars 4, 2024
Therapy, Head, Neoplasm, Neck, CLS, AML, Part, TME, Sale, Pembrolizumab, Multiple myeloma, Bristol Myers Squibb, Symantec Endpoint Protection, TPS, Hyponatremia, Cytokine, Hypertension, Tumor microenvironment, Patient, Immunoglobulin A, MD Anderson Cancer Center, Hyperlipidemia, Disease, Biology, HNSCC, Hypercholesterolemia, CPS, PD-L1, Cancer, Pharmaceutical industry

Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.

Key Points: 
  • Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.
  • MTEM intends to initiate a study of MT-0169 in CD38+ acute leukemias in collaboration with MD Anderson Cancer Center.
  • Additional details on each of these participant’s clinical profile and response to the investigational treatment are provided below.
  • MTEM plans on initiating an investigator sponsored trial with MD Anderson Cancer Center to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment

Retrieved on: 
måndag, februari 12, 2024
LDH, Infection, FDA, Food, Hemoglobinuria, Paroxysmal nocturnal hemoglobinuria, Alternative complement pathway, ODD, Safety, Atypical hemolytic uremic syndrome, ANCA, Death, Patient, Hyperlipidemia, AP, Diagnosis, AAV, PNH, Chelsea Handler, Hemolysis, Pharmaceutical industry

FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.

Key Points: 
  • FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.
  • The FDA has approved phase 1b/Phase II clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), Atypical Hemolytic Uremic Syndrome (aHUS), and most recently, ANCA vasculitis (AAV).
  • CLEVELAND, Feb. 12, 2024 (GLOBE NEWSWIRE) --  NovelMed today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • FDA's recognition of Ruxoprubart as an orphan drug for PNH underscores its potential to fulfill a crucial need for individuals grappling with this disease condition.