Edema

Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121)

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четверг, мая 30, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Patient, Headache, Patient satisfaction, Urinary tract infection, Endocrine Society, Erythema, TSH, Prevalence, FDA, Doctor of Pharmacy, Safety, Edema, Medication, Absorption, Hypothyroidism, Injection, Șaeș, Journal, Fatigue, Pharmaceutical industry

XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.

Key Points: 
  • XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.
  • The Phase 2 study included the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks).
  • Participants entered the study on a stable oral dose (≥ 3 months) with normal TSH and free T4 laboratory values.
  • Participants were receiving a daily oral levothyroxine dose of 83.7 ± 31.14 mcg (mean ± SD) at study entry.

Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression

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пятница, мая 31, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Traffic barrier, Lung, Principal, Progression-free survival, Patient, Diarrhea, Anaplastic lymphoma kinase, Headache, Cough, Weight gain, Learning, Hypercholesterolemia, Risk, Hypertriglyceridemia, Inc., Lung cancer, Doctor of Philosophy, Arthralgia, PFS, Disease, Edema, NSCLC, APLS, Death, Peripheral neuropathy, HR, Abstract, Periodic breathing, Hypertension, PFE, ASCO, Journal, Brain, Society, ALK, Confidence interval, Aes, MBBS, Crizotinib, Pharmaceutical industry

Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.

Key Points: 
  • Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.
  • “These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
  • “This updated analysis shows that LORBRENA helped patients live longer without disease progression, with the majority of patients experiencing sustained benefit for over five years, including nearly all patients having protection from progression of disease in the brain.
  • At the time of analysis, 50% of patients in the CROWN trial were still receiving LORBRENA compared to 5% of patients receiving XALKORI.

scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

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вторник, мая 14, 2024
Hypersensitivity, New Drug Application, Patient, Creatinine, Ototoxicity, Uric acid, Azotemia, Huber loss, Coma, Anuria, Cerebral edema, Urinary retention, Erythema, NYHA, Furosemide, Heart failure, Ascites, Hepatic encephalopathy, Kidney, Bruise, Shanda, Urine, FDA, Glucose, Trial of the century, GTN, Edema, PDUFA, Chronic kidney disease, Cirrhosis, Change Healthcare, Growth, Research, Diuresis, BUN, Dehydration, Thrombosis, Deafness, Congestion, CO2, Oliguria, Benign prostatic hyperplasia, Organic acid, History, Blood volume, Hypoproteinemia, Embolism, Tinnitus, Pharmaceutical industry

BURLINGTON, Mass., May 14, 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 first quarter ended March 31, 2024, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • Costs of product revenues were $1.8 million for the first quarter of 2024, compared to $0.6 million for the first quarter of 2023.
  • Research and development expenses were $2.7 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • scPharmaceuticals reported a net loss of $14.1 million for the first quarter of 2024, compared to $11.2 million for the first quarter of 2023.

Cogent Biosciences Reports First Quarter 2024 Financial Results

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вторник, мая 7, 2024
AAAAI, American Academy, Brain, Safety, Stromal cell, Mouse, PEAK, Cash, Research, HER2, GIST, ASCO, Patient, Society, AACR, APEX, Edema, G&A, Growth, Pharmaceutical industry

WALTHAM, Mass. and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2024.

Key Points: 
  • and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2024.
  • Cogent remains on track to complete enrollment in PEAK by the end of 2024 and report top-line results by the end of 2025.
  • G&A expenses include non-cash stock compensation expense of $5.0 million for the first quarter of 2024 as compared to $2.9 million for the first quarter of 2023.
  • Net Loss: Net loss was $58.3 million for the first quarter of 2024 compared to a net loss of $38.6 million for the first quarter of 2023.

BioCryst Reports First Quarter 2024 Financial Results and Provides Business Update

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понедельник, мая 6, 2024
Net, Skin, Investment, Solubility, Research, Diabetes, BioCryst Pharmaceuticals, Plasma, Injection, Webcast, Kallikrein, Prescription, Disease, Dehydration, Patient, Eye, Operating cost, Physician, Paratriathlon, EPS, Workforce, Infection, DME, Clinical trial, HAE, Diabetic retinopathy, Edema, Genetic disorder, GAAP, Netherton syndrome, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • These two successes helped us exceed our revenue projections for the quarter and, as a result, we are increasing our revenue guidance for 2024,” said Charlie Gayer, chief commercial officer of BioCryst.
  • Interest expense was $24.5 million in the first quarter of 2024, compared to $27.4 million in the first quarter of 2023 (-10.6 percent y-o-y).
  • Our references to our first quarter 2024 “non-GAAP pro forma” financial measures of adjusted net loss and adjusted earnings per share constitute non-GAAP financial measures.
  • ET today to discuss the financial results and provide a corporate update.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

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среда, апреля 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 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 that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Excision BioTherapeutics to Present Positive Data from its HSV-1 Keratitis Program, EBT-104, at the ASGCT 2024 Annual Meeting

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понедельник, апреля 22, 2024
Corneal opacity, AAV2, Nanopore, Rabbit, Immortalised cell line, Genomics, LTR, CRISPR, Genetic engineering, Abraxis BioScience, Infection, Gene, RNA, Recurrence, HeLa, Paratriathlon, Cell, HSK, AAV, Vero cell, Research, Pterygopalatine ganglion, FACS, PCR, Disease, DNA, Therapy, Viral load, HIV-1, Society, CDS, Gag, ICP0, Genome, Herpes simplex keratitis, LAT, Orientation, Annual general meeting, Edema, Valaciclovir, SAN, Vaccine

Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.

Key Points: 
  • Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.
  • Although current anti-HSV-1 therapies interfere with viral DNA replication, they do not eliminate HSV-1 reservoirs or prevent recurrence.
  • CRISPR/Cas-mediated gene editing can potentially address the underlying causes of the disease by directly eliminating the latent HSV-1 reservoirs.
  • The 440 guide RNA pairs formed with these 42 PlmCasX guide RNAs were tested in tissue culture for DNA excision efficiency.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

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пятница, апреля 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

Rakuten Medical's Poster Presentation at AACR 2024 Demonstrates Reduction in Photoimmunotherapy-induced Edema in Mice with COX-2 Inhibition

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пятница, апреля 12, 2024
Ephrin A2, Mouse, Nonsteroidal anti-inflammatory drug, Necrosis, Blood, Poster, Thromboxane A2, Research, Edema, Neutrophil, Light, Patient, Neoplasm, Head, AACR, Meloxicam, SAN, Vaccine

In the study presented in this poster, Rakuten Medical developed a mouse tumor model to assess edema following photoimmunotherapy and evaluated various steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) for edema reduction using the model.

Key Points: 
  • In the study presented in this poster, Rakuten Medical developed a mouse tumor model to assess edema following photoimmunotherapy and evaluated various steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) for edema reduction using the model.
  • It was also confirmed that the reduction in edema with meloxicam was not associated with a loss of therapeutic benefit based on measurement of tumor growth.
  • Control mice did not generate edema, but mice treated with conjugate plus light showed a light-dose dependent increase in edema volume which peaked at 6h post light delivery.
  • The reduction in edema with meloxicam did not have negative impact on tumor growth inhibition.

Endonovo Closes Asset Purchase Agreement for a Minimum of $50M With SofPulse, Inc

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четверг, марта 28, 2024
Growth, Inflammation, Sale, Acquisition, Pain management, IPO, Athlete, IP, OTC, Therapy, Wellness, Intellectual property, Pain, APA, Marketing, FDA, Edema, PEMF, Security (finance)

With completion of the APA, both Endonovo and SofPulse, Inc. share a strategic vision and a commitment for long term growth.

Key Points: 
  • With completion of the APA, both Endonovo and SofPulse, Inc. share a strategic vision and a commitment for long term growth.
  • The APA transaction for the purchase of Endonovo assets and IP by SofPulse, Inc. is now closed, pending the customary regulatory approvals.
  • Key points of the APA include:
    Agreement to engage Adeptus, a qualified third party's asset valuation firm.
  • Agreement for SofPulse Inc. to issue $50 million in freely traded stock through an S-1 registration, priced at $5.00 per share to Endonovo.