MPH

Pharming announces completion of enrollment in pediatric clinical trial of leniolisib

Retrieved on: 
Monday, April 8, 2024
Disease, Ageing, Patient, Euronext Amsterdam, Clinical trial, MPH, Index, Safety, FDA, APDS, Food, Pharmaceutical industry

Pharming plans to include data from this 4–11-year-old trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS, beginning in 2025.

Key Points: 
  • Pharming plans to include data from this 4–11-year-old trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS, beginning in 2025.
  • Anurag Relan, MD, MPH, Chief Medical Officer of Pharming, commented:
    “This is the first clinical trial for younger pediatric patients with APDS, who have a significant unmet need for a disease modifying treatment.
  • I am pleased with the progress made in our Phase III pediatric clinical program evaluating leniolisib in children with APDS.
  • Eligible patients enrolled in either of the pediatric trials will continue to receive leniolisib for a year after the initial 12-week treatment period through an open-label extension trial.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy

Retrieved on: 
Friday, April 5, 2024
Retina, Disease, Inflammation, Patient, Data, Cohort, Șaeș, Life, Clinical trial, Armada, MPH, Injection, Safety, DSMB, FACS, Vaccine, Lipid metabolism, Geographic atrophy, Oxidative stress, Pharmaceutical industry

Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
  • An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial.
  • Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)].

American Oncology Network Expands to Hawaii, Welcomes New Practice to Network

Retrieved on: 
Wednesday, April 3, 2024
Yee, Diagnosis, RN, AON, Immunotherapy, Environment, Patient, APRN, MSN, MPH, Cancer, Physician, Health, Nursing

HONOLULU, April 03, 2024 (GLOBE NEWSWIRE) -- American Oncology Network (AON) (Nasdaq: AONC), one of the nation’s fastest-growing community oncology networks, is pleased to announce its expansion into Hawaii and welcomes Hawaii Cancer Care to the network.

Key Points: 
  • HONOLULU, April 03, 2024 (GLOBE NEWSWIRE) -- American Oncology Network (AON) (Nasdaq: AONC), one of the nation’s fastest-growing community oncology networks, is pleased to announce its expansion into Hawaii and welcomes Hawaii Cancer Care to the network.
  • “Our goal at AON is to partner with independent community oncology practices to further close the cancer care gap,” said Todd Schonherz , AON’s chief executive officer.
  • “We are happy to be partnering with American Oncology Network,” said the physicians at Hawaii Cancer Care.
  • The practice already has a comprehensive menu of cancer care services that are valuable to patients at every stage in their diagnosis.

TearSolutions, Inc. Appoints Louis M Alpern, MD, MPH, FACS, FICS to its Board of Directors

Retrieved on: 
Wednesday, April 3, 2024
Principal, Harvard Medical School, Alpern, Public, Public health, FICS, Private practice, Telecanthus, Patient, DED, MPH, Therapy, FACS, Frustration, Ophthalmology, Pharmaceutical industry

“Dr.

Key Points: 
  • “Dr.
  • Alpern brings extensive real-world clinical experience treating patients with ocular surface disease, having prescribed or trialed virtually every dry eye treatment available,” said Anil Asrani, President and CEO of TearSolutions.
  • “Dr.
  • He received his Doctor of Medicine from Harvard Medical School and his Master of Public Health from the Harvard School of Public Health.

Nxera Pharma Appoints Experienced Senior Strategy Consultant Patrick Branch as Head of Business Development for Japan and APAC

Retrieved on: 
Wednesday, April 3, 2024
University of London, University, Public health, Growth, Health, Patient, Business development, Columbia University, Head, L.E.K. Consulting, MBA, Medtech, Master, MPH, Partner, SOAS

Tokyo, Japan and Cambridge, UK, 3 April 2024 - Nxera Pharma (“Nxera” or “the Company”; TSE: 4565) – formerly known as Sosei Group or Sosei Heptares – today announces the appointment of Japan pharmaceutical sector expert, Mr. Patrick Branch, as Head of Business Development for Japan and the APAC region.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 3 April 2024 - Nxera Pharma (“Nxera” or “the Company”; TSE: 4565) – formerly known as Sosei Group or Sosei Heptares – today announces the appointment of Japan pharmaceutical sector expert, Mr. Patrick Branch, as Head of Business Development for Japan and the APAC region.
  • Branch will join Nxera’s global Business Development team that is led by Dr. Marcus Messenger.
  • He will be based in Nxera’s Tokyo office and will oversee Japan and regional disease area strategy, search and evaluation, and transaction activities.
  • Chris Cargill, CEO and President of Nxera Pharma, commented: “I’m delighted to welcome Patrick to the business development team at Nxera.

New survey reveals top employee behaviors to improve health-related quality of life

Retrieved on: 
Tuesday, April 2, 2024
Health, Obesity, Job satisfaction, PHD, Risk, Diabetes, Weight loss, Stroke, Research, Sleep, University, Quality of life, MPH, Ageing

These survey findings are in line with the University of North Carolina study that recognized enhanced quality of life as a benefit of and motivator for physical activity.

Key Points: 
  • These survey findings are in line with the University of North Carolina study that recognized enhanced quality of life as a benefit of and motivator for physical activity.
  • Wondr Health conducted the survey in February 2024 and asked individuals to share what they do to improve their quality of life as they age.
  • Wondr Health partners with employers and health plans to deliver programs for full-spectrum weight and obesity management.
  • Beginning with proven, world-class behavioral support participants improve their quality of life, physical movement, sleep, and more while sustaining long-term weight loss.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410ST—a Modifier Gene Therapy—in GARDian Study for Stargardt Disease

Retrieved on: 
Monday, April 1, 2024
Stargardt disease, Gardian, Patient, Cohort, Șaeș, Clinical trial, MPH, Safety, DSMB, FACS, Vaccine, FDA, Pharmaceutical industry

Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three patients with Stargardt disease were dosed in the Phase 1/2 clinical trial to date.
  • An additional three patients will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410ST in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with Stargardt disease,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial.
  • Phase 1 is a multicenter, open-label, dose ranging study consisting of three dose levels [low dose (3.75×1010 vg/mL), medium dose (7.5×1010 vg/mL), and high dose (2.25×1011 vg/mL)].

JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

Retrieved on: 
Thursday, March 28, 2024
Hemodynamics, Disease, TCT, Bernard Marcus, Aortic stenosis, Aortic regurgitation, Patient, Mortality, IDE, Columbia University, Manuscript, MPH, Safety, TAVR, Trial of the century, Trilogy, THV, FDA, Food, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .

Key Points: 
  • IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .
  • As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
  • The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
  • LINK TO REGISTER
    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.