Cerebral edema

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

Retrieved on: 
Thursday, March 28, 2024
OS, Savolitinib, Conference, NMPA, AstraZeneca, NSCLC, Grade 3, DCR, New Drug Application, WCLC, Patient, Neoplasm, Cerebral edema, Gamma-glutamyltransferase, MET, Lung cancer, HKEX, Dor, Safety, PFS, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Avenacy Announces Launch of Furosemide for Injection in the U.S. Market

Retrieved on: 
Wednesday, March 20, 2024
Hospitals, Pharmaceutical, Health, Cardiology, Furosemide, Cerebral edema, Kidney, Nephrotic syndrome, Route of administration, Entrepreneurship, Diuresis, DCAT, Patient, Boxed warning, Heart, Water, Multimedia, Food, FDA, Liver, Edema, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix® for Injection (furosemide) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix® for Injection (furosemide) approved by the U.S. Food and Drug Administration.
  • View the full release here: https://www.businesswire.com/news/home/20240320953949/en/
    “The launch of Furosemide for Injection builds on the two launches announced earlier this week and further demonstrates the speed at which we are progressing the business,” said Jeff Yordon, Co-Founder and CEO of Avenacy.
  • Avenacy will begin shipping Furosemide for Injection to wholesale partners next week.
  • The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.

Mustang Bio Announces Publication in Nature Medicine of Data from Phase 1 Trial Evaluating MB-101 IL13Rα2-targeted CAR T-Cells in High-Grade Glioma

Retrieved on: 
Thursday, March 7, 2024
T cell, Glioblastoma, Arms, ICT, ICV, Traffic barrier, Toxicity, Headache, Biopsy, DSM-IV codes, Cerebrospinal fluid, City, Cancer, Central nervous system, CXCL10, TME, Cerebral edema, Dual, Hope, GBM, Safety, CXCL9, Fatigue, Hypertension, Translation, CNS, Tumor microenvironment, Patient, Arm, Spinal cord, Survival, Brain, Nature Medicine, Infrared spectroscopy correlation table, Vaccine

WORCESTER, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced Phase 1 clinical data were published in Nature Medicine that demonstrated the promising safety and clinical activity of Mustang’s MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of patients with recurrent and refractory malignant glioma, including glioblastoma.

Key Points: 
  • MB-101 was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Mustang.
  • Central nervous system (CNS) increases in inflammatory cytokines, including IFNγ, CXCL9, and CXCL10, were associated with CAR T-cell administration and bioactivity.
  • Primary endpoints were safety and feasibility, with secondary endpoints measuring therapy-related cytokine dynamics, CAR T-cell persistence and clinical outcomes.
  • Dr. Brown has a financial interest in Mustang and has previously been a paid consultant for the company.

Oculis Provides Updates at R&D Day on Late-Stage Clinical Trials and Announces Key Leadership Appointments

Retrieved on: 
Wednesday, February 28, 2024
ASRS, Senior, Paris Diderot University, SAB, Reno 1868 FC, Growth, Visual acuity, University, DED, Telecanthus, Organization, Principal, Teaching hospital, Retina, Anthropology, Diabetic retinopathy, Therapy, OCS, Inflammation, CSO, DME, American Academy, Simmons University, M.A, Clinical research, ASCRS, Society, Cerebral edema, Eastern Virginia Medical School, Patient, Partner (business rank), Medicine, Pharmaceutical industry

In-person and virtual R&D Day today from 9:00 AM to 11:00 AM EST at the InterContinental New York Barclay.

Key Points: 
  • In-person and virtual R&D Day today from 9:00 AM to 11:00 AM EST at the InterContinental New York Barclay.
  • “2024 promises to be another exciting year for Oculis as we advance our late-stage clinical development programs.
  • I am certain that the extensive experience each of them brings will be invaluable to Oculis,” said Riad Sherif, M.D., Chief Executive Officer of Oculis.
  • Oculis also announced today key executive appointments to bolster its leadership and scientific advisory teams.

Alzheon to Present Biomarker, Brain Preservation, and Clinical Results from Pivotal Program of Oral ALZ-801/Valiltramiprosate at International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders

Retrieved on: 
Tuesday, February 27, 2024
Research, Neurology, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Shift, Wuxi, Doctor of Philosophy, WuXi AppTec, MD, Risk, Conference, Unit, Cerebral edema, Biomarker, Patient, Drug, NDA, DSM-IV codes

“The new treatment landscape for Alzheimer’s disease is beginning to take shape, and Alzheon’s simplified approach has an opportunity to transform the standard of care and improve access to treatment for Alzheimer’s patients.

Key Points: 
  • “The new treatment landscape for Alzheimer’s disease is beginning to take shape, and Alzheon’s simplified approach has an opportunity to transform the standard of care and improve access to treatment for Alzheimer’s patients.
  • ALZ-801’s efficacy data and favorable safety profile, showing no increased risk of vasogenic edema, underscore the differentiated clinical profile of our treatment,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • Results from our pivotal APOLLOE4 Phase 3 trial will set the stage for the potential NDA filing this year and commercial launch in 2025.”
    Alzheon presentations include two posters and two symposium presentations.
  • If the results of our study are positive, we will be moving quickly to bring an oral option to Alzheimer’s patients and their families,” said John Hey, PhD, Chief Scientific Officer.

Closed Loop Medicine Demonstrates Application of Novel Drug Plus Software Product for Personalized Treatment of Hypertension

Retrieved on: 
Thursday, February 8, 2024
Medical Devices, Health, Health Technology, Clinical Trials, Pharmaceutical, Biotechnology, COVID-19, Innovation, American College, Senior, Orthostatic hypertension, Medicine, Invention, Death, Amlodipine, Therapy, Disease, Drug intolerance, Patient, Cerebral edema, COVID, Triage, Trust, Hypertension, BP, Journal, American Heart Association, Journal of Human Hypertension, JAHA, Innovate UK, Blood pressure, Pharmaceutical industry

Closed Loop Medicine Ltd., a leading TechBio company developing combination prescription drug plus software therapy products that deliver personalized dose optimization, today announced the publication of a peer-reviewed study in the Journal of the American Heart Association (JAHA) (1).

Key Points: 
  • Closed Loop Medicine Ltd., a leading TechBio company developing combination prescription drug plus software therapy products that deliver personalized dose optimization, today announced the publication of a peer-reviewed study in the Journal of the American Heart Association (JAHA) (1).
  • Hypertension is the leading preventable cause of morbidity and premature death worldwide.
  • High adherence rates were reported (both app usage and medication) and patient retention was exceptionally high with no discontinuations due to drug intolerance.
  • Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “These findings are invaluable in demonstrating the power of personalizing the dose of existing therapeutics in areas as widely impactful as hypertension.

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, Hypothyroidism, INN, Woman, Progression-free survival, Nausea, Syndrome, Heart, Cancer, Inflammation, Skull, Proteinuria, Anatomy, Cell division, IIA, Diarrhea, Fatigue, ATC, Capsule, Bleeding, Pancreas, RET, VEGF, FGFR, Cerebral edema, Neoplasm, Stroke, Enzyme, Liver failure, Safety, Kidney cancer, Arthralgia, Heart failure, Patient, Urine, Medical Subject Headings, Stomatitis, Immune system, Everolimus, International, Encephalopathy, Language, Somatic symptom disorder, Blood, Mouth, Catherine Disher, Select, Medicine, Vomiting, Pembrolizumab, Cholesterol, PDGF, Kidney failure, Weight loss, Headache, KIT, Brain, Acral lentiginous melanoma, Swelling, Hypoesthesia, Splenic infarction, Confusion, European Medicines Agency, RCC, Kidney, Growth, Sunitinib, Hypercholesterolemia, Rash, Medical device

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

scPharmaceuticals Announces Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue

Retrieved on: 
Thursday, January 4, 2024
Coma, Urine, Hepatic encephalopathy, Ascites, Kidney, Oliguria, Physician, Benign prostatic hyperplasia, Blood volume, Uric acid, Organic acid, Anuria, Urinary retention, NYHA, Furosemide, Cerebral edema, Hypersensitivity, Diuresis, Thrombosis, Deafness, Glucose, Azotemia, Ototoxicity, Creatinine, Tinnitus, Traction, BUN, Hypoproteinemia, Edema, Growth, Investment, Congestion, Huber loss, Patient, Bruise, Dehydration, CO2, Heart failure, Cirrhosis, Embolism, History, Erythema, Pharmaceutical industry

BURLINGTON, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced preliminary unaudited fourth quarter 2023 net FUROSCIX revenue in a range of $5.9 million to $6.1 million, representing sequential growth of 55% to 61% over $3.8 million net FUROSCIX revenue reported for the third quarter of 2023.

Key Points: 
  • For the full year 2023, the Company anticipates net revenue to be in a range of $13.4 million to $13.6 million.
  • The gross-to-net discount decreased to approximately 18% from launch through the end of Q4 versus 21% from launch through the end of Q3.
  • Inventory levels at the end of Q4 2023 were consistent with levels at the end of Q3 2023.
  • scPharmaceuticals will report its final and complete fourth quarter and full-year 2023 financial results in March.

Alzheon CEO Dr. Martin Tolar to Present ALZ-801/Valiltramiprosate Investigational Oral Alzheimer’s Treatment Program at Nobel Forum at Karolinska Institute in Stockholm, Sweden

Retrieved on: 
Wednesday, January 3, 2024
Science, Neurology, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Karolinska Institute, Cognition, Cerebrospinal fluid, Implementation, Risk, Cerebral edema, MD, Doctor of Philosophy, Nerve, Early, Neurotoxicity, Amyloid, Patient, Safety, Therapy, Pharmaceutical industry

Alzheon Founder, President, and CEO, Martin Tolar, MD, PhD, will present an overview of investigational oral ALZ-801/valiltramiprosate anti-amyloid oligomer treatment program in the section “Optimal Treatment for Future – Combination Therapy?” moderated by Kaj Blennow, MD, PhD, on January 19 at 1:30 PM CET (7:30 AM EST).

Key Points: 
  • Alzheon Founder, President, and CEO, Martin Tolar, MD, PhD, will present an overview of investigational oral ALZ-801/valiltramiprosate anti-amyloid oligomer treatment program in the section “Optimal Treatment for Future – Combination Therapy?” moderated by Kaj Blennow, MD, PhD, on January 19 at 1:30 PM CET (7:30 AM EST).
  • “We are honored to have received an invitation to present at the prestigious Nobel Forum and discuss how ALZ-801 tablet could help shape the future therapeutic landscape for Alzheimer’s disease.
  • Alzheon's simplified approach with an oral tablet has an opportunity to transform the standard of care for millions of patients,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • “ALZ-801 efficacy data and a favorable safety profile, showing no increased risk of vasogenic edema, underscore the differentiated clinical profile of the treatment.