Cerebral edema

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

Retrieved on: 
torsdag, januari 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: 
onsdag, januari 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.

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024
Medical Subject Headings, Floater, Cataract, Marketing, Protein, BRVO, INN, Neovascularization, Complication, ATC, DME, Endophthalmitis, Retinal detachment, Blood, Bleeding, International, Ranibizumab, AMD, Injection, Disease, Diabetes, Language, CRVO, Eye, Pressure, Swelling, Inflammation, Intraocular pressure, RVO, European Medicines Agency, Infection, Cerebral edema, CNV, Growth, Select, Macular edema, Patient, Safety, Anatomy, Paratriathlon, Retina, IIA, Retinal haemorrhage, Three-body problem, Medical device

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024
Patient, Medical Subject Headings, Marketing, Prednisolone, European Commission, Liver, Agency, Survival, CYP17, INN, Woman, Docetaxel, Fracture, ATC, Male, Hormone, Hypersensitivity, International, Cough, Man, European, Prednisone, Disease, Language, Prostate cancer, Cerebral edema, Eating, Castration, Cancer, Urinary tract infection, Neoplasm, Testosterone, Prostate, Abiraterone acetate, European Medicines Agency, Food, Tablet, Growth, Select, Anatomy, Medicine, IIA, Hypokalemia

Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Retrieved on: 
tisdag, januari 2, 2024
Marketing, INN, Risk, Constipation, Needle, Body surface area, Nausea, DNA, Cancer, T-ALL, Anatomy, Paresthesia, Cough, IIA, Hypoesthesia, Diarrhea, Fever, Fatigue, Infection, Bone marrow, ATC, Pain, Disease, Ageing, Somnolence, Periodic breathing, Cerebral edema, Edema, Enzyme, Safety, Anemia, Tumor lysis syndrome, Patient, Medical Subject Headings, Febrile neutropenia, Agency, Guanine, International, Paralysis, LBL, Neutropenia, Blood, Language, Myalgia, Dizziness, Thrombocytopenia, Nervous system, Thymus, Select, Vomiting, Peripheral neuropathy, Survival, Lymph, Extremities, System, Weakness, Headache, Brain, Swelling, European Medicines Agency, Convulsion, Growth, Cell, Lymphatic system, Medical device

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

NanoPhoria Bioscience Publishes Groundbreaking Study in Major Cardiology Journal

Retrieved on: 
tisdag, januari 2, 2024
Research, Medical Devices, Surgery, Clinical Trials, Cardiology, Other Health, Biotechnology, General Health, Health, Science, Blood pressure, Heart rate, FESC, JACC, Injection, Disease, FACC, Massachusetts General Hospital, MD, Doctor of Philosophy, Heart failure, Inhalation, Animal, Cerebral edema, LTCC, American College, Patient, Facial muscles, Harvard Medical School, Journal, Medical device

NanoPhoria srl, a pre-clinical stage biotech company, is pleased to announce today the publication of a groundbreaking study in the field of cardiology, conducted using a clinically relevant pig model of heart failure.

Key Points: 
  • NanoPhoria srl, a pre-clinical stage biotech company, is pleased to announce today the publication of a groundbreaking study in the field of cardiology, conducted using a clinically relevant pig model of heart failure.
  • This significant piece of preclinical research, titled “Lung-to-Heart Nano-in-Micro Peptide Promotes Cardiac Recovery in a Pig Model of Chronic Heart Failure,” was published by our co-founders in the Journal of the American College of Cardiology (JACC), a prominent peer-reviewed medical journal.
  • Results confirming the therapeutic effect recapitulated ex vivo in cardiac myofibrils and biopsies from treated heart failure animals.
  • “Additionally, our research showcases a major advancement in the field of heart disease treatment.

Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)

Retrieved on: 
måndag, november 20, 2023
DSM-IV codes, Senior, Authorization, Alzheimer's disease, Dementia, MRI, MLS, Amyloid-related imaging abnormalities, Marketing, EMA, WHO, European, Brain, Doctor of Philosophy, World Health Organization, Cerebral edema, ARIA, European Medicines Agency, Regulatory affairs, Marketing authorisation, Pathology, Amyloid, Patient, Therapy, Medical imaging

These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

Key Points: 
  • These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.
  • Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
  • Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

scPharmaceuticals Inc. Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
onsdag, november 8, 2023
NYHA, Cirrhosis, FDA, Research, Uric acid, Trial of the century, Deafness, Furosemide, Thrombosis, Erythema, Benign prostatic hyperplasia, Embolism, Internationalized domain name, Government, Hypoproteinemia, History, Kidney, Physician, Cerebral edema, Anuria, Bruise, Edema, Hepatic encephalopathy, Huber loss, Ototoxicity, Chronic kidney disease, Urinary retention, Congestion, Blood volume, Growth, Urine, Dehydration, Shanda, Diuresis, Pharmacy, Tinnitus, Medicaid, Azotemia, BUN, CO2, Oliguria, Organic acid, CKD, Investment, Patient, Creatinine, Heart failure, Hypersensitivity, Glucose, Coma, New York Heart Association Functional Classification, Ascites, Security (finance), Cryptocurrency, Pharmaceutical industry, Rare-earth element, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Nov. 08, 2023 (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 third quarter ended September 30, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $3.8 million, and cost of product revenues were $1.1 million for the third quarter of 2023.
  • Research and development expenses were $3.4 million for the third quarter of 2023, compared to $3.7 million for the third quarter of 2022.
  • Selling, general and administrative expenses were $14.1 million for the third quarter of 2023, compared to $6.3 million for the third quarter of 2022.
  • As of September 30, 2023, scPharmaceuticals’ total shares outstanding was 35,859,045.
    scPharmaceuticals’ management will host a conference call and webcast to review the Company’s third quarter 2023 results today, Wednesday, November 8, at 4:30 p.m.

Oculis to Present a Late-Breaking Abstract at the American Academy of Ophthalmology 2023 Annual Meeting on the Positive Stage 1 Results from Phase 3 DIAMOND Trial for Diabetic Macular Edema

Retrieved on: 
onsdag, november 1, 2023
Cerebral edema, CME, Intravitreal injection, Diabetic retinopathy, DME, AAO, Dexamethasone, Diabetes, Inflammation, OCS, American Academy, 2008 Giro d'Italia, Stage 1 to Stage 11, American Academy of Ophthalmology, Annual general meeting, Paratriathlon, Pain, Patient, Trial of the century, Retina, Pharmaceutical industry

A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 Eye Drops in Diabetic Macular Edema (DME)

Key Points: 
  • A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 Eye Drops in Diabetic Macular Edema (DME)
    OCS-01 is Oculis’ lead product candidate and the first investigational eye drop for both front and back of the eye indications, with positive results in Stage 1 of the Phase 3 DIAMOND trial for DME announced in May 2023, and positive Phase 3 OPTIMIZE trial results for inflammation and pain following cataract surgery announced in August 2023.
  • Furthermore, the investigator-initiated LEOPARD study evaluating OCS-01 for the treatment of cystoid macular edema (CME) enrolled its first patient in August 2023.
  • Leveraging Oculis’ proprietary OPTIREACH® technology, OCS-01 is a novel, high concentration (15 mg/ml), topical formulation of dexamethasone.
  • If approved, OCS-01 has the potential to become the first topical preservative-free eye drop for the treatment of DME, the leading cause of vision loss and legal blindness in patients with diabetes.

Lecanemab named one of the world's best inventions in 2023 by TIME

Retrieved on: 
tisdag, oktober 24, 2023
Risk, Aneurysm, Vomiting, Cerebral edema, Focal neurologic signs, Incidence, Dementia, Nausea, Disease, Intraparenchymal hemorrhage, Intracerebral hemorrhage, CET, Chills, AI, Paracetamol, Hypersensitivity, Memory, Lecanemab, Vascular malformation, MRI, Excipient, Neuroimaging, Fatal, Thought, Dizziness, Aspirin, Edema, Anticoagulant, Cerebral amyloid angiopathy, Magnetic resonance imaging, Patient, Bronchospasm, Alzheimer's disease, Anaphylaxis, Genetic testing, TIME, ARIA, Arthralgia, Research, Eisai, Fever, Hypotension, Amyloid, Headache, Siderosis, Behavior, Invention, Observation, Hypertension, Confusion, Seizure, Angioedema, Status epilepticus, Tissue plasminogen activator, Pharmaceutical industry, Lace, Medical imaging, Copper

"It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.

Key Points: 
  • "It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.
  • TIME's annual list of the best inventions includes "200 extraordinary innovations changing lives."
  • The information was released for public disclosure, through the agency of the contact persons below, on October 24, 2023, at 4.50 p.m. CET.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.