Quality of life (healthcare)

Merck to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024

Retrieved on: 
Donnerstag, Mai 23, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Dana–Farber Cancer Institute, Neck, Risk, Liver, Avelumab, DDR, Carcinoma, University of California, Health care, Abstract (summary), Survival, Cough, BSC, CEACAM5, Head, Atri, ADC, Abstract, Phase II, ATM, Quality of life (healthcare), CRT, Phase, Neoplasm, Safety, Institute of Cancer Research, Cancer, ASCO, Society, IAP, BIRC, Antigen, Patient, Pharmacokinetics, ADP, DNA, PARP, Phases of clinical research, University, Death, Clinical trial, Brain, Chemoradiotherapy, Annual general meeting, Pharmaceutical industry

Merck, a leading science and technology company, today announced new research from the company’s diverse oncology portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4, Chicago.

Key Points: 
  • Merck, a leading science and technology company, today announced new research from the company’s diverse oncology portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4, Chicago.
  • Data from 40 patients treated across seven dose levels in Part 1A of the study showed encouraging clinical activity and a manageable and predictable safety profile in this population.
  • New findings for tuvusertib, the lead oral ATRi asset from the company’s portfolio of DNA damage response (DDR) inhibitors (Abstracts 3018, 2612, 2614).
  • Data show a manageable safety profile and preliminary efficacy in patients with advanced solid tumors, confirming suitability of this combination for further evaluation.

EMD Serono to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024

Retrieved on: 
Donnerstag, Mai 23, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Dana–Farber Cancer Institute, Neck, Risk, Liver, Avelumab, DDR, Carcinoma, University of California, Health care, Abstract (summary), Survival, Cough, BSC, Merck Serono, CEACAM5, Head, Atri, ADC, Abstract, Phase II, Merck, ATM, Quality of life (healthcare), CRT, Phase, Neoplasm, Safety, Institute of Cancer Research, Cancer, ASCO, Society, IAP, BIRC, Antigen, Patient, Pharmacokinetics, ADP, DNA, PARP, Phases of clinical research, University, Merck Group, Death, Clinical trial, Brain, Chemoradiotherapy, Annual general meeting, Pharmaceutical industry

Data from 40 patients treated across seven dose levels in Part 1A of the study showed encouraging clinical activity and a manageable and predictable safety profile in this population.

Key Points: 
  • Data from 40 patients treated across seven dose levels in Part 1A of the study showed encouraging clinical activity and a manageable and predictable safety profile in this population.
  • New findings for tuvusertib, the lead oral ATRi asset from the company’s portfolio of DNA damage response (DDR) inhibitors (Abstracts 3018, 2612, 2614).
  • Data from the DDRiver™ Clinical Trials program highlight the potential of the investigational oral ataxia telangiectasia and RAD3-related inhibitor (ATRi) tuvusertib in various combinations across solid tumors.
  • Data show a manageable safety profile and preliminary efficacy in patients with advanced solid tumors, confirming suitability of this combination for further evaluation.

Merck to Present New Data at 2024 ASCO Annual Meeting Demonstrating Advancements in Novel Oncology Treatment Approaches Across Broad Portfolio and Diverse Pipeline

Retrieved on: 
Mittwoch, Mai 15, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, HER2, BTC, Cisplatin, PBC, Brentuximab vedotin, HCC, INT, Merck & Co., Pros, Endometrial cancer, ADC, Abstract, Melanoma, Hepatocellular carcinoma, Physician, PD-L1, Quality of life (healthcare), TNBC, Pembrolizumab, Safety, NSCLC, Cancer, Carcinoma, ASCO, Society, Patient, AHCC, Lung cancer, Therapy, Radiation, Daiichi Sankyo, MRK, Conjugation, Webcast, Quality of life, Annual general meeting, Georgetown University, Pharmaceutical industry

New data being shared at the meeting showcase the company’s continued progress to advance clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates.

Key Points: 
  • New data being shared at the meeting showcase the company’s continued progress to advance clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates.
  • “This year’s ASCO is also particularly meaningful as we approach 10 years since KEYTRUDA was first approved in the U.S.
  • As Merck continues to build its broad oncology portfolio, the company will also present data at ASCO from its diverse pipeline of investigational candidates, many being evaluated in combination with KEYTRUDA.
  • Merck will hold an Oncology Investor Event to coincide with the 2024 ASCO Annual Meeting on Monday, June 3, 2024, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program.

Travere Therapeutics Reports First Quarter 2024 Financial Results

Retrieved on: 
Montag, Mai 6, 2024
FDA, Total, Risk, Ligand Pharmaceuticals, European Commission, Research, UPCR, Webcast, HCU, IND, EGFR, PDUFA, SIMD, Civil service commission, Diagnosis, PMDA, GAAP, CMA, Congress, Table, PROTECT, Priority review, Food, Abstract, FSGS, Income tax, CSL Vifor, Quarter, Medication, Therapy, SAN, Plasma, Urine, International, Safety, Proteinuria, ANNA, Immunoglobulin A, Homocysteine, Investigational New Drug, Society, Shanda, New Drug Application, Genetic, European, Disease, Patient, Quality of life (healthcare), IPR, Bank statement, Growth, Pharmaceutical industry

Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.

Key Points: 
  • Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.
  • Travere Therapeutics will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET to discuss company updates as well as first quarter 2024 financial results.
  • The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results.

First Interim Analysis of PROSPER Study Details Patient-Reported Symptom Burden of Mycosis Fungoides and Sézary Syndrome

Retrieved on: 
Montag, April 15, 2024
Oncology, Health, General Health, Research, Pharmaceutical, Science, TSA, University, Patient, MF, Cutaneous T-cell lymphoma, Skin, Blood, Kyowa Kirin, Thermoregulation, CTCL, Disease, Lymphoma, Quality of life (healthcare), Lymph, Mycosis fungoides, University of Birmingham, Neoplasm

In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs.

Key Points: 
  • In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs.
  • In the current interim analysis, symptom scores (mean) were reported for 20 adult patients with relapsed or refractory disease (8 MF; 12 SS) over their first 16 weeks of mogamulizumab treatment.
  • Prior to treatment initiation, patients reported their symptom burden using a 1 – 10 numeric scale.
  • At baseline, skin itch scored highest (6.6) followed by skin redness (6.2), flaking skin (5.9) and skin pain (4.0).

Travere Therapeutics to Present Abstracts on FILSPARI® (sparsentan) in IgA Nephropathy at World Congress of Nephrology and the American Nephrology Nurses Association

Retrieved on: 
Mittwoch, April 3, 2024
ART, IgA nephropathy, Congress, Quality of life (healthcare), Patient, SAN, Kidney failure, Immunoglobulin A, RAAS, FSGS, PROTECT, Focal segmental glomerulosclerosis, Abstract, Kidney disease, Therapy, WCN, Proteinuria, ANNA, Communications satellite

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.

Key Points: 
  • SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.
  • At WCN, the Company will present subgroup analyses of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) showing the treatment effect across participants with different levels of baseline proteinuria.
  • At ANNA, the Company will present additional insights from the HONUS trial, including health-related quality of life (HRQoL) data and the humanistic burden experienced by patients with IgAN and focal segmental glomerulosclerosis (FSGS).
  • “The data we are presenting at WCN and ANNA reinforce the wealth of evidence supporting FILSPARI’s profile to become an effective foundational treatment replacing RAAS inhibition, with the potential to reduce the lifetime risk of kidney failure for patients with IgAN,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

Pharvaris Announces Phase 3 Clinical Study Design for Recently Initiated RAPIDe-3 Study, and Presents Quality-of-Life Improvement and Caregiver Behavior Data at Two Recent HAE Congresses

Retrieved on: 
Montag, März 18, 2024
Angioedema, Conference, EOP, Attack, Quality of life (healthcare), Network, Safety, HAE, Hereditary angioedema, Patient, Adolescence, Heredity, Country, National Congress, Physician, Medicine, Pharmaceutical industry

“We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Key Points: 
  • “We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.
  • The RAPIDe-3 study is designed to assess the effectiveness of deucrictibant in addressing that unmet need.
  • RAPIDe-3 is a randomized, double-blind, placebo-controlled, crossover study, which is designed to enroll approximately 120 adolescent and adult participants globally.
  • The data illustrates that HRQoL is negatively impacted, including functional and psychological impairment, in people with HAE.

EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?, Online, European Medicines Agency, Amsterdam, t[...]

Retrieved on: 
Sonntag, März 10, 2024
Pros, EMA, PRO, Research, Facilitation, Quality of life (healthcare), Treatment, Location, European Medicines Agency, Patient, HRQOL, Medical device

This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.

Key Points: 
  • This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.
  • The aims of the workshop are to:
    - Understand the current global landscape on the use of PROs and HRQOL for evaluation of anti-cancer treatments across different stakeholder groups.
  • - Understand the use of validated PRO questionnaires to measure core HRQOL outcomes and disease-related symptoms; and PRO Item Libraries in the development of trial-specific/treatment-specific item lists.
  • The recording of this meeting will be made available after the event.

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

Retrieved on: 
Mittwoch, Februar 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.

LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE)

Retrieved on: 
Mittwoch, Januar 24, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, IGA, Hope, Delgocitinib, Patient, DLQI, CHE, Alitretinoin, Aes, Safety, Dermatology Life Quality Index, LEO, Leo Pharma, Quality of life (healthcare), Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.
  • Delgocitinib cream achieved the primary outcome measure of the trial by demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules.
  • Furthermore, patients receiving delgocitinib cream had a lower number of treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules.
  • Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.