Creatinine

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.

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

Retrieved on: 
Friday, April 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®

Retrieved on: 
Tuesday, March 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: 
Tuesday, March 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

Retrieved on: 
Friday, January 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.

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Lithium, UGT, Risk, Digoxin, Shanda, Hypotension, FDA, SGLT1, Type 2 diabetes, Acute kidney injury, Congress, Pyelonephritis, Conference, Fever, Ketoacidosis, Pregabalin, Pregnancy, Pain, Assessment, Gabapentin, Tenderness, New Drug Application, Amber Grid, HCM, Common, SGLT2, PROGRESS, Hypertrophic cardiomyopathy, Diabetes, Kidney, Heart failure, Dialysis, History, Patient, Prescription, Type, Neuropathic pain, Webcast, Insulin, T2DM, EGFR, Erythema, T1DM, Hypoglycemia, Partnership, Contraindication, Diarrhea, NDA, Incidence, Swelling, Urinary tract infection, Hospital, Chronic kidney disease, Internationalized domain name, Metabolic acidosis, Creatinine, Growth, Lactation, Pharmaceutical industry

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

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.

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

Retrieved on: 
Friday, December 15, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, MSD, Medicine, DSM-IV codes, PD-L1, NYSE, Potassium, Food, Progression-free survival, RECIST, Merck & Co., Head, Pneumonia, Blood transfusion, Dana–Farber Cancer Institute, Risk, Lymphocyte, Hypoxia, Everolimus, Bleeding, IMDC, Fatigue, Sepsis, Patient, Pregnancy, PFS, Effectiveness, Belzutifan, Week, VHL, VEGF, RCC, COVID-19, PD-1, Creatinine, TKI, ORR, Harvard Medical School, Death, Anemia, Fatal, Sodium, Hospital, Pleural effusion, HIV disease progression rates, MRK, Pharmaceutical industry, Birth control, Merck

Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.

Key Points: 
  • Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.
  • Patients could have received up to three prior treatment regimens and were required to have measurable disease per RECIST v1.1.
  • Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
  • Adverse reactions that required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%).

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

Retrieved on: 
Friday, December 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, DSM-IV codes, Vomiting, Woman, Safety, CDK, Potassium, Therapy, Letrozole, Progression-free survival, Back pain, Fulvestrant, Abdominal pain, Doctor of Science, Headache, Risk, Liver, Disease, Cholesterol, PIK3CA, Constipation, Fatigue, Indigestion, Anastrozole, Patient, Multimedia, PFS, Metastasis, MD Anderson Cancer Center, ESR1, FDA, MBC, Neoplasm, Creatinine, Standard of care, Diarrhea, MD, Nausea, Cancer, Trial of the century, Death, Exemestane, Menarini, Anemia, SOC, TP53, Knowledge, Arthralgia, HIV disease progression rates, Triglyceride, Medical imaging, Pharmaceutical industry

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.

DoseMe Adds Cefepime to Its Model-informed Precision Dosing Platform

Retrieved on: 
Monday, December 4, 2023
Technology, Biotechnology, FDA, Health, Pharmaceutical, Other Science, University, Research, Software, Infectious Diseases, Education, Health Technology, Science, Data Management, Hospice and palliative medicine, Neutropenia, Genetically modified bacteria, Cefepime, BCPS, TDM, Pneumonia, Doctor of Pharmacy, Risk, Fungal infection, Serum, Patient, Infection, Midwestern University, Pharmacokinetics, University of Illinois Chicago, Kidney, Owen Scheetz, Bacteria, Creatinine, Neurotoxicity, EGFR, Bias, Postgraduate education, Skin, Therapeutic drug monitoring, Pharmaceutical industry, Pharmacology, Dosem

DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.

Key Points: 
  • DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.
  • His research continues to highlight three keys to infectious disease monitoring - real time beta lactam monitoring, therapeutic drug monitoring and precision dosing.
  • “Similar to many beta lactam treatments, Cefepime displays a large amount of variability between patients and having DoseMeRx enables precision dosing,” stated Scheetz.
  • Greater recognition of the benefits of Model-informed Precision Dosing (MIPD) software for enhancing TDM and dosing precision necessitates thorough validation of models and reassessment of current workflows.