Creatinine

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

Retrieved on: 
Thursday, January 4, 2024
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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.

TRUQAP™ (capivasertib) Now Available from Onco360

Retrieved on: 
Wednesday, November 29, 2023
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Vomiting, AstraZeneca, Neutrophil, Toxicity, Stomatitis, Incidence, National Cancer Institute, Fulvestrant, White, Specialty pharmacy, Lymphocyte, PIK3CA, Breast cancer, Fatigue, Patient, Pharmacy, PFS, PTEN, FDA, Neoplasm, Creatinine, HER2, Diarrhea, Nausea, Cancer, Diagnosis, Death, AKT1, Recurrence, HIV disease progression rates, Triglyceride, Pharmaceutical industry

Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by AstraZeneca for Truqap™ (capivasertib).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by AstraZeneca for Truqap™ (capivasertib).
  • FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.
  • “Onco360 is excited to partner with the team at AstraZeneca and become a specialty pharmacy provider for Truqap™,” said Benito Fernandez, Chief Commercial Officer.
  • “We continue to see therapeutic advancements that support our mission; to improve the lives of patients battling cancer, rare, and orphan disease.

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

Retrieved on: 
Wednesday, November 8, 2023
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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.

Jana Care, Inc. Announces Initial Closing of a $6 Million Financing Round to Complete Commercialization of its Self-administered Blood Tests for Kidney and Heart Disease

Retrieved on: 
Wednesday, November 8, 2023
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The Company's self-administered, quantitative blood testing platform enables remote risk stratification of chronic kidney disease and heart failure patients.

Key Points: 
  • The Company's self-administered, quantitative blood testing platform enables remote risk stratification of chronic kidney disease and heart failure patients.
  • In addition to its ongoing partnerships with global leaders in diagnostic technologies and pharmaceutical development, Jana Care welcomes lead investor IAG Capital Partners.
  • Jana Care will use the funds to expand the development of Jana Care's quantitative blood testing platform.
  • The platform is designed to enable self-administered blood tests at-home and allows clinicians to review the test results remotely as needed.

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
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Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialize ORSERDU upon its regulatory approval in China.
  • “Patients living with metastatic breast cancer need effective and tolerable options,” said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Neoplasm, Patient, Abdominal pain, Constipation, SOC, Headache, Food, Progression-free survival, Fatigue, European Commission, Vomiting, Diarrhea, PFS, Safety, DSM-IV codes, HIV disease progression rates, Holding, Nausea, Republic, Civil service commission, ESR1, Risk, Triglyceride, MBC, ER, Breast cancer, Anemia, Woman, Oncology, Indigestion, Cancer, Therapy, Arthralgia, Creatinine, Potassium, Death, Back pain, Cholesterol, Mutation, Menarini, Medical imaging, Pharmaceutical industry

Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialise ORSERDU upon its regulatory approval in China.
  • "Patients living with metastatic breast cancer need effective and tolerable options," said Elcin Barker Ergun, CEO of the Menarini Group.
  • "We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can offer efficacy in a once-daily pill."

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Neoplasm, Patient, Abdominal pain, Constipation, SOC, Headache, Food, Progression-free survival, Fatigue, European Commission, Vomiting, Diarrhea, PFS, Safety, DSM-IV codes, HIV disease progression rates, Holding, Nausea, Republic, Civil service commission, ESR1, Risk, Triglyceride, MBC, ER, Breast cancer, Anemia, Woman, Oncology, Indigestion, Cancer, Therapy, Arthralgia, Creatinine, Potassium, Death, Back pain, Cholesterol, Mutation, Menarini, Medical imaging, Pharmaceutical industry

Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialise ORSERDU upon its regulatory approval in China.
  • "Patients living with metastatic breast cancer need effective and tolerable options," said Elcin Barker Ergun, CEO of the Menarini Group.
  • "We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can offer efficacy in a once-daily pill."