Liver

Sangamo Therapeutics Announces Data From Novel Proprietary Neurotropic AAV Capsid Demonstrating Industry-leading Blood-brain Barrier Penetration and Brain Transduction in NHPs

Retrieved on: 
Wednesday, March 13, 2024
Research, Neurology, Genetics, Clinical Trials, Health, Pharmaceutical, General Health, Other Science, Science, STAC, AAV, Sangamo Therapeutics, Gene, Brain, Capsid, Gene expression, ALS, BBB, Central nervous system, Novartis, CNS, CTA, DRG, Traffic barrier, Prion, NHP, Tropism, IND, Nav1.7, Neuron, Biogen, Tauopathy, Excipient, Therapy, DSM-IV codes, Spinal cord, Liver, Animal, Vaccine

Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.

Key Points: 
  • Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.
  • In NHP studies when administered intravenously at clinically relevant doses, STAC-BBB demonstrated its potential to be a leading neurotropic capsid.
  • Exhibited 700-fold higher transgene expression in neurons compared to the benchmark capsid AAV9 and outperformed all other known published neurotropic capsid variants evaluated in the study.
  • STAC-BBB was well tolerated in NHPs, with no notable treatment related pathological findings in brain, spinal cord or peripheral tissues.

FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance

Retrieved on: 
Wednesday, April 3, 2024
Patient, Trauma, Hospital, Acquisition, Coagulopathy, Cartridge, Operating, Hemostasis, American Red Cross, Bleeding, Intensive care medicine, FDA, Liver, Journal of Cardiothoracic Surgery, Food, Medical device

DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge. HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples. Today's announcement enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus® Cartridge.

Key Points: 
  • HemoSonics' Quantra® Hemostasis Analyzer provides comprehensive blood analysis that details critical bleeding disorders and helps clinicians manage patients back into hemostasis.
  • DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics , a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge.
  • HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples.
  • "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system.

IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes

Retrieved on: 
Tuesday, April 2, 2024
De novo, Freezing, Neoplasm, FDA, Liver, Neurology, Breast cancer, Kidney, Medical imaging

CAESAREA, Israel, April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.

Key Points: 
  • CAESAREA, Israel, April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes.
  • The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.
  • This new application for IceCure's next-generation single probe XSense™ with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication.
  • "As our ProSense® single probe cryoablation system builds market traction globally, we continue to develop our technology pipeline with innovative single and multi-probe systems," stated IceCure CEO Eyal Shamir.

PANTHERx®Rare Selected by Edenbridge Pharmaceuticals as Specialty Pharmacy for Yargesa® (miglustat 100 mg capsules)

Retrieved on: 
Monday, April 1, 2024
Disease, Capsule, Patient, Pharmacy, Bone pain, Hepatomegaly, Enzyme replacement therapy, Anemia, Gaucher, Thrombocytopenia, Liver, Spleen, Pharmaceutical industry

Yargesa® is a glucosylceramide synthase inhibitor that exerts its effects through a process called substrate reduction therapy.

Key Points: 
  • Yargesa® is a glucosylceramide synthase inhibitor that exerts its effects through a process called substrate reduction therapy.
  • Through this process, Yargesa® reduces the buildup of harmful glycosphingolipids and symptoms of the disease.
  • This accumulation leads to manifestations including but not limited to enlarged spleen or liver, hepatomegaly, anemia, thrombocytopenia, and bone pain.
  • "We appreciate Edenbridge Pharmaceuticals' commitment to making a difference in the lives of patients with Type 1 Gaucher disease.

American Liver Foundation Celebrates Donate Life Month with New Patient Resources, Programs and Support

Retrieved on: 
Monday, April 1, 2024
American Liver Foundation, Journey, Celebration, Liver disease, Environment, Caregiver, Patient, Social media, News, Liver transplantation, MD, ALF, North Shore University Hospital, Liver, Partner, Fatigue, Sadness, Dentistry

April is Donate Life Month and American Liver Foundation (ALF) has new patient resources, programs and support available to all liver transplant patients and the caregivers supporting them.

Key Points: 
  • April is Donate Life Month and American Liver Foundation (ALF) has new patient resources, programs and support available to all liver transplant patients and the caregivers supporting them.
  • "An informed patient is critically important to making the best decisions about care and ensuring the most favorable outcomes," said Lorraine Stiehl, Chief Executive Officer, American Liver Foundation and caregiver to a transplant recipient.
  • Liver patients, families and loved ones are invited to celebrate the gift of life and the importance of liver transplantation.
  • Throughout Donate Life Month ALF encourages patients, caregivers and organ donors to be part of the national conversation!

Stubborn Digestion Issues? PLAMECA Can Help

Retrieved on: 
Wednesday, March 27, 2024
Diagnosis, Ginger, Esophagus, Gastrointestinal tract, Extrapyramidal system, GERD, Gallbladder, Cancer, Irritable bowel syndrome, Crohn's disease, Quality of life, Great Way Government, Hiatal hernia, Pancreas, IBS, Lactose intolerance, Stomach, Liver, Digestion, Animal feed

FORT LAUDERDALE, Fla., March 27, 2024 /PRNewswire/ -- There are many kinds of digestional disorders. Some are severe, while others are minor (yet uncomfortable) inconveniences. For those managing ongoing digestional discomfort, PLAMECA's Digestissimoh! offers clean, safe, and effective relief.

Key Points: 
  • Is a Great Way to Lighten Digestion Across the Board
    FORT LAUDERDALE, Fla., March 27, 2024 /PRNewswire/ -- There are many kinds of digestional disorders.
  • supplement is a perfect example of a safe, natural, and effective way to manage stubborn digestive issues over time," Fernández explains.
  • uses natural ingredients such as ginger, digestive enzymes, and marine coral to lighten digestion.
  • offers a safe, effective, natural way to lighten their digestion and keep things functioning on a day-to-day basis.

Delcath Systems to Host Fourth Quarter and Full Year 2023 Results and Business Update Call

Retrieved on: 
Tuesday, March 19, 2024
Delcath Systems, Liver

NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update.

Key Points: 
  • NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update.
  • To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Delcath Systems Appoints Martha S. Rook as Chief Operating Officer

Retrieved on: 
Monday, March 18, 2024
DSM-IV codes, Harvard Medical School, Employment, MIT, Delcath Systems, Knowledge, Gene, Gene editing, Molecular biology, Senior, Doctor of Philosophy, Biochemistry, Chemistry, Texas A&M University, Compensated emancipation, Liver, Sigma-Aldrich, Pharmaceutical industry

NEW YORK, March 18, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Martha S. Rook as its new Chief Operating Officer (COO).

Key Points: 
  • NEW YORK, March 18, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Martha S. Rook as its new Chief Operating Officer (COO).
  • Martha S. Rook, Ph.D., is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process development and biologics manufacturing.
  • She joins Delcath from insitro where she served as a Chief Technical Operations Officer and was responsible for core research services, facilities and laboratory operations, quality and project and portfolio management.
  • "We are thrilled to welcome Martha, a Senior business leader with more than 25 years of experience, to the leadership team," said Gerard Michel, Chief Executive Officer of Delcath.

FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy

Retrieved on: 
Monday, March 18, 2024
Encephalitis, Locomotion, Brain, B cell, Bone marrow, Cell, Dietary supplement, Nervous system, Risk, Patient, Public, Urinary tract infection, Animal, Metachromasia, DSM-IV codes, Peripheral nervous system, Viral, Human services, Hope, Death, Quality of life, Atidarsagene autotemcel, Rash, Therapy, Metachromatic leukodystrophy, Natural history, Fever, MLD, Heated tobacco product, Safety, Disability studies, Cosmetics, Health, Vaccine, Food, Swelling, FDA, Liver, Multimedia, ARSA, Pharmaceutical industry

Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system.

Key Points: 
  • Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system.
  • The stem cells are collected from the patient and modified by adding a functional copy of the ARSA gene.
  • In children with MLD, treatment with Lenmeldy significantly reduced the risk of severe motor impairment or death compared with untreated children.
  • Eighty five percent of the children treated had normal language and performance IQ scores, which has not been reported in untreated children.

Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand

Retrieved on: 
Monday, March 18, 2024
Civil service commission, Neuroblastoma, Ototoxicity, Partnership, Central nervous system, ANZ, Risk, FENC, Patient, Hepatoblastoma, Neoplasm, Cancer, MHRA, TSX, Hearing loss, European, Cisplatin, Safety, European Commission, Liver, Arnold & Porter, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, England, March 18, 2024 /PRNewswire/ -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to

Key Points: 
  • Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories.
  • It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe.
  • The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients.
  • Moelis & Company LLC acted as financial advisor, and LaBarge Weinstein LLP acted as legal advisor to Fennec.