Creatinine

scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives

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Tuesday, September 19, 2023
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BURLINGTON, Mass., Sept. 19, 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 that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.

Key Points: 
  • The Company also announced today feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD.
  • In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL.
  • CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.
  • “We are very pleased to have reached alignment with the FDA on the advancement of these two very important long-term growth initiatives for our company,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.

European Commission Approves Menarini Group’s ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

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Wednesday, September 20, 2023
Oncology, Health, Consumer, Women, Clinical Trials, Pharmaceutical, Biotechnology, University, Civil service commission, Progression-free survival, Creatinine, Anemia, Triglyceride, ESR1, Neoplasm, Safety, CDK, Cholesterol, European Medicines Agency, MBC, Indigestion, Advanced Therapy Medicinal Product, Constipation, Woman, Mutation, Multimedia, SOC, Arthralgia, Doctor of Philosophy, Diarrhea, PFS, Abdominal pain, EMA, Committee for Medicinal Products for Human Use, Vomiting, Fatigue, European Institute, Back pain, European Institute of Oncology, IRCCS, HIV disease progression rates, MD, Patient, European, Risk, Division, Drug development, Nausea, Headache, CHMP, Death, Potassium, University of Milano-Bicocca, Disease, European Commission, ER, Breast cancer, Pharmaceutical industry

With this approval, ORSERDU is the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • With this approval, ORSERDU is the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • ESR1 mutations are acquired mutations that develop as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC.
  • ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

HealthVerity releases its expertly curated Chronic Kidney Disease Masterset to synchronize the science

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Tuesday, August 22, 2023
Glycated hemoglobin, Medicaid, Noise, Diabetes, Creatinine, EMR, Microalbuminuria, Research, Risk, RWD, Science, Hypertension, Medicare, Provider, HIV disease progression rates, Data, Patient, Body mass index, Mortality, Death, CKD, ICPE, Disease, Pharmaceutical industry

PHILADELPHIA, Aug. 22, 2023 /PRNewswire/ -- HealthVerity, the leader in synchronizing transformational technologies and real-world data (RWD) to advance the science, today announced the launch of the HealthVerity Chronic Kidney Disease (CKD) Masterset, an expertly curated dataset that synchronizes lab results, commercial, Medicare and Medicaid claims, and electronic medical records (EMRs) from the nation's largest healthcare and consumer data ecosystem. An addition to our growing suite of HealthVerity Mastersets, including the Provider Diversity Index 2023 edition and the Maternal Outcomes Masterset, the CKD Masterset compiles all CKD-relevant clinical attributes into one comprehensive, research-ready masterset, accelerating research by saving valuable time and resources.

Key Points: 
  • HealthVerity experts standardize and deduplicate the data, ensuring all of the most relevant CKD data points are included, without additional noise from RWD, providing a more concise, easy-to-use masterset.
  • "CKD is complicated by several comorbid conditions, such as diabetes, hypertension and heart disease," explained Reyna Klesh, vice president, data products and innovation at HealthVerity.
  • HealthVerity will continue to add to their Masterset Series, providing researchers speed to insights through expertly curated datasets that profile some of the most important diseases.
  • Book your meeting with the HealthVerity team at booth #402 in Halifax, Nova Scotia, August 23-27, 2023.

Eloxx Pharmaceuticals Reports Second Quarter 2023 Financial and Operating Results and Provides Business Update

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Monday, August 14, 2023
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Podocytes are specialized cells that bind to the glomerular basement membrane and form finger-like extensions called foot processes that enable efficient ultrafiltration.

Key Points: 
  • Podocytes are specialized cells that bind to the glomerular basement membrane and form finger-like extensions called foot processes that enable efficient ultrafiltration.
  • Podocyte injury leads to the effacement (loss) of podocyte foot processes and proteinuria in nearly all cases of Alport syndrome.
  • An IND application for ELX-02 is expected to be submitted to the FDA in the third quarter of 2023.
  • Eloxx remains focused on its liquidity position and is committed to raising additional capital in the near term in order to fund its operating plan through the end of 2023 and beyond.

Viracta Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
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“In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.

Key Points: 
  • “In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.
  • Prioritization also enables the allocation of resources to those indications with the greatest probability of success and market opportunity in key geographies.
  • Patients with extranodal NK/T-cell lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma will continue to be enrolled.
  • In July 2023, Viracta received a Notice of Allowance from the US Patent and Trademark Office on Viracta’s patent claims directed to a next-generation formulation of nanatinostat.

TheracosBio and SmithRx Collaborate to Offer Newly Approved Diabetes Drug Brenzavvy™ (bexagliflozin) to Members with Type 2 Diabetes

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Thursday, August 17, 2023
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Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.

Key Points: 
  • Working with TheracosBio and Cost Plus Drugs, SmithRx now provides BRENZAVVY as an option following its launch in July 2023.
  • BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
  • Diabetes is the most expensive chronic condition in the U.S. and accounts for 1 of every 4 dollars spent on healthcare.
  • In patients with type 1 diabetes mellitus, BRENZAVVY significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond background rate.

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

Retrieved on: 
Thursday, August 10, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, Medicaid, Hypoproteinemia, Organic acid, Heart failure, Urine, Creatinine, Patient satisfaction, Cirrhosis, Dehydration, Tinnitus, Glucose, Deafness, Huber loss, Edema, Hepatic encephalopathy, Prescription, Research, Part, Oliguria, History, Government, Russell 3000 Index, Trial of the century, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Investment, Patient, Russell, Urinary retention, Cardiology, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Anuria, Security (finance), Cryptocurrency, Pharmaceutical industry, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Aug. 10, 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 second quarter ended June 30, 2023, and provided a business update. 

Key Points: 
  • For the second quarter ended June 30, 2023, scPharmaceuticals reports:
    Obtained national Medicaid coverage of FUROSCIX effective July 1, 2023.
  • Ended the second quarter of 2023 with cash, cash equivalents and short-term investments of $102.9 million.
  • Research and development expenses were $2.9 million for the second quarter of 2023, compared to $5.1 million for the second quarter of 2022.
  • Selling, general and administrative expenses were $12.1 million for the second quarter of 2023, compared to $4.3 million for the second quarter of 2022.

Viracta Therapeutics Announces Publication in Blood Advances Demonstrating Promising and Durable Signal of Nana-val Efficacy in Patients with Relapsed or Refractory (R/R) Epstein-Barr Virus-Positive (EBV+) Lymphoma

Retrieved on: 
Tuesday, August 8, 2023
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SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced the publication of clinical data from an open-label, multicenter, Phase 1b/2 study of Nana-val in 55 patients with R/R EBV+ lymphoma in Blood Advances. Results showed complete responses (CRs) achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers: peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), and post-transplant lymphoproliferative disease (PTLD). This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here.

Key Points: 
  • This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here .
  • The published paper includes an additional 10-month follow-up period, which demonstrated durable response durations across multiple EBV+ lymphoma subtypes.
  • Overall, trial participants received a median of two prior therapies before entering the trial, with 75% (41/55) being refractory to their last therapy.
  • Initial data from the Nana-val Phase 1b/2 clinical trial were previously presented at the 2021 American Society of Hematology (ASH) Annual Meeting .

SYNSOL Launches Second-Generation Smart Toilet with Medical Grade Electrolyte Detection and ECG Monitoring: A Leap in Proactive Health Management

Retrieved on: 
Thursday, August 3, 2023
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"These tests were previously only possible in medical grade labs and hospitals," said Dr. Wenchong Wang, SYNSOL's Chief Scientist.

Key Points: 
  • "These tests were previously only possible in medical grade labs and hospitals," said Dr. Wenchong Wang, SYNSOL's Chief Scientist.
  • "But with our latest technology, medical level data can now be obtained through everyday activities like using the toilet."
  • The 6-lead ECG technology released by SYNSOL operates similarly to hospital ECG machines by collecting heart electrical activity for medical analysis.
  • "Our understanding of the smart toilet has always revolved around personal health," emphasized Chen, Founder of Geometry Healthtech.

scPharmaceuticals Announces Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion

Retrieved on: 
Tuesday, August 1, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, US Foods, Hypoproteinemia, Organic acid, Heart failure, Chronic kidney disease, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Patent, Patient, Physician, Urinary retention, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Kidney disease, Anuria, Pharmaceutical industry, Medical device

FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

Key Points: 
  • FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.
  • “We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the FUROSCIX indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.
  • “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from FUROSCIX.
  • FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.