Creatinine

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

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火曜日, 5月 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.

Apellis Pharmaceuticals Reports First Quarter 2024 Financial Results

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火曜日, 5月 7, 2024
DTC, Safety, Creatinine, VALIANT, Swedish Orphan Biovitrum, MAA, CHMP, Justice, Insurance, Webcast, Administration, Patient, CJEU, CAD, EMA, Cold agglutinin disease, Judgement, Standard of care, PNH, APLS, European Medicines Agency, Injection, Ageing, Pharmaceutical industry

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Key Points: 
  • ET
    WALTHAM, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), today announced its first quarter 2024 financial results and business highlights.
  • EMPAVELI for the treatment of PNH:
    Generated $25.6 million in EMPAVELI U.S. net product revenue in the first quarter of 2024.
  • Apellis reported a net loss of $66.4 million for the first quarter 2024, compared to a net loss of $177.8 million for the same period in 2023.
  • Apellis will host a conference call and webcast to discuss its first quarter 2024 financial results and business highlights today, May 7, 2024, at 8:30 a.m.

CYNTHIA DELGADO AND NEIL POWE NAMED TO TIME100 HEALTH LIST FOR FIGHTING KIDNEY TRANSPLANT BIAS

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木曜日, 5月 2, 2024
Task force, FASN, National Kidney Foundation, Filtration, Risk, Kidney failure, Health, Kidney, Cystatin C, GFR, Black, TIME, Creatinine, CKD, Organ, Patient, American Society of Nephrology, Society, MPH, Kidney transplantation, ASN, MBA, NKF, Chronic kidney disease, Pioneer, Global health, Nursing

The magazine recognized Cynthia Delgado, MD, FASN and Neil Powe, MD, MPH, MBA for their efforts to correct racial bias in the algorithm used to diagnose kidney diseases, an algorithm that often determines access to a kidney transplant.

Key Points: 
  • The magazine recognized Cynthia Delgado, MD, FASN and Neil Powe, MD, MPH, MBA for their efforts to correct racial bias in the algorithm used to diagnose kidney diseases, an algorithm that often determines access to a kidney transplant.
  • TIME included NKF/ASN Task Force co-chairs in its first-ever list of the 100 most influential people in global health.
  • Under the updated, race-free algorithm, some Black patients recently received modified times on the wait list for a kidney transplant.
  • The TIME100 Health List recognizes the world's most influential individuals in health across five categories: Innovators, Titans, Pioneers, Leaders, and Catalysts.

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

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水曜日, 4月 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.

IMFINZI® (durvalumab) plus chemotherapy doubled overall survival rate at three years for patients with advanced biliary tract cancer in TOPAZ-1 Phase III trial

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火曜日, 4月 16, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Warning, Administration, Creatinine, Pneumonitis, Radiation, Prednisone, Patient, Incidence, Infection

Results showed 15.4% of patients experienced treatment-related serious adverse events with IMFINZI plus chemotherapy versus 17.3% with chemotherapy alone.

Key Points: 
  • Results showed 15.4% of patients experienced treatment-related serious adverse events with IMFINZI plus chemotherapy versus 17.3% with chemotherapy alone.
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
  • The primary endpoint is overall survival and key secondary endpoints included progression-free survival, objective response rate and safety.

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

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水曜日, 3月 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.

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

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金曜日, 4月 5, 2024
Research, FDA, Clinical Trials, Biometrics, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Chemoradiotherapy, CRT, Small-cell carcinoma, Radiation, AstraZeneca, Survival, NSCLC, Immunotherapy, Disease, Infection, Carcinoma, Incidence, Progression-free survival, Patient, Warning, Doctor of Philosophy, Prednisone, Adrenocorticotropic hormone, Creatinine, Prognosis, PFS, Recurrence, ACTH, Administration, Pneumonitis, SCLC, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

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火曜日, 3月 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
火曜日, 3月 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

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金曜日, 1月 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.