Adverse event

First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

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水曜日, 5月 22, 2024
ATP, ACL, Risk, Molina Healthcare, Ageing, Agent handling, Adverse event, CVD, Esperion Therapeutics, Back pain, Angioedema, Cholesterol, Gout, Kidney, Constipation, Treatment, Civil service commission, European Commission, Fetus, Anaphylaxis, Hypersensitivity, Moyamoya disease, Bempedoic acid, Urinary tract infection, Anemia, Hypercholesterolemia, Upper respiratory tract infection, Safety, Ezetimibe, CLEAR, Incidence, Bronchitis, Excipient, Diet, Gallstone, Rash, Patient, Cardiovascular disease, Diarrhea, Abdominal pain, Uric acid, Spasm, University, University of Milan, Therapy, Arthralgia, Sinusitis, Pregnancy, European, Stroke, Health, Common, Death, FDC, Fatigue, Myocardial infarction, Tablet, Rupture, Pain, CHMP, Dietary supplement

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

Key Points: 
  • Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
  • Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
  • “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

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

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日曜日, 4月 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.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

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金曜日, 3月 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

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金曜日, 3月 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Rampart Health Bursts Out of Stealth Mode to Report 77% Disease Control in Metastatic Cancer from First-in-Human Phase 2 Trial ("Abscopal 5001") of Multiplex Intra-tumoral Immunotherapy (MITI)

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月曜日, 11月 6, 2023
Society for Immunotherapy of Cancer, Cyclophosphamide, Partial, PD-1, Lung, Bladder cancer, MBA, Adverse event, Immune system, Abscopal effect, Liver disease, MITI, GM-CSF, Society, Preventive healthcare, Patient, SAN, Sarcoma, Vaccine, Immunotherapy, Cancer

Thirteen patients received at least one intra-tumoral treatment of Multiplex Intra-Tumoral Immunotherapy (MITI) consisting of cryo-ablation followed by intra-tumoral injection of PD-1 and CTLA-4 inhibitors and cyclophosphamide; GM-CSF was administered subcutaneously.

Key Points: 
  • Thirteen patients received at least one intra-tumoral treatment of Multiplex Intra-Tumoral Immunotherapy (MITI) consisting of cryo-ablation followed by intra-tumoral injection of PD-1 and CTLA-4 inhibitors and cyclophosphamide; GM-CSF was administered subcutaneously.
  • Partial response was observed in 5 patients (38.5%) and stable disease in 5 (38.5%), for a disease control rate of 77%.
  • We were gratified by the high rates of Disease Control and Abscopal Effect, as well as the favorable Adverse Event profile compared with systemic immunotherapy.
  • Remarkably, this therapy appeared to be applicable to many types of solid cancer."

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

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木曜日, 6月 23, 2022
Antibody, Adverse event, National Institute of Virology, Cancer, Fever, Serious adverse event, HCC, Epitope, Death, NMPA, Infection, AST, ILC, Institute, HSA, National Medical Products Administration, Helicobacter pylori, Bloating, CccDNA, Biotechnology, Liver cancer, Bilirubin, Hospital, Engineering, SAE, Peking Union Medical College, Hepatitis B, HBsAg, Disease, TCR, Clinical trial, SCG, Hepatocellular carcinoma, Institute of technology, Neurotoxicity, CRS, AE, Patient, Serum, Diagnosis, Cell, Annual general meeting, HBV, Pharmaceutical industry, Medical device, Vaccine, Virology, MD

SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

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木曜日, 6月 23, 2022
Antibody, Adverse event, National Institute of Virology, Cancer, Fever, Serious adverse event, HCC, Epitope, Death, NMPA, Infection, AST, ILC, Institute, HSA, National Medical Products Administration, Helicobacter pylori, Bloating, CccDNA, Biotechnology, Liver cancer, Bilirubin, Hospital, Engineering, SAE, Peking Union Medical College, Hepatitis B, HBsAg, Disease, TCR, Clinical trial, SCG, Hepatocellular carcinoma, Institute of technology, Neurotoxicity, CRS, AE, Patient, Serum, Diagnosis, Cell, Annual general meeting, HBV, Pharmaceutical industry, Medical device, Vaccine, Virology, MD

SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

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火曜日, 7月 20, 2021
Biotechnology, AIDS, Health, Pharmaceutical, Clinical trials, Clinical research, Health sciences, Health, Adverse event, Placebo, Advanced Encryption Standard, Medicine, Upadacitinib, Islatravir (MK-8591), Merck, ISLATRAVIR (MK-8591), MERCK

After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.

Key Points: 
  • After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.
  • Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir.
  • Unblinded safety data showed that both doses of islatravir were generally well tolerated versus placebo over 24 weeks and most AEs were mild (73.5%).
  • The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Canadian researchers to study best approaches to possible adverse events following COVID-19 vaccination

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火曜日, 7月 13, 2021
Health sciences, Health, Drug Safety, Medicine, Vaccination, Clinical research, Biotechnology, Vaccine adverse event, Clinical trials, COVID-19 vaccine, Vaccine, Adverse event

This study is an extension of an existing vaccine safety program that provides important public health information about adverse events following immunization (AEFI) for all vaccines authorized for use in adults and children.

Key Points: 
  • This study is an extension of an existing vaccine safety program that provides important public health information about adverse events following immunization (AEFI) for all vaccines authorized for use in adults and children.
  • The network also has international links to align with international standards, and to incorporate global evidence into the Canadian context.
  • To be included in the study, patients who experience an adverse event following COVID-19 vaccination can be referred to the SIC Network by a healthcare provider for further assessment.
  • We must systematically document and follow up with patients who experience a medically significant or unexpected adverse event.

Galderma Receives FDA Approval for Restylane® Contour for Cheek Augmentation and Correction of Midface Contour Deficiencies

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火曜日, 6月 29, 2021
Medical specialties, Oral and maxillofacial surgery, Surgery, Clinical medicine, Oral surgery, Glycosaminoglycans, Otorhinolaryngology, Restylane, Cheek augmentation, Lidocaine, Adverse event

Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies.

Key Points: 
  • Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies.
  • Most patients* (85%) did not experience any adverse events (AEs) related to treatment with Restylane Contour.
  • The Restylane family of products are indicated for patients over the age of 21, and includes Restylane, Restylane-L, RestylaneLyft with Lidocaine, Restylane Silk, Restylane Kysse, Restylane Refyne, Restylane Defyne, and Restylane Contour.
  • Restylane Contour is for cheek augmentation and for the correction of midface contour deficiencies.