Plasma protein binding

Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis

Retrieved on: 
Tuesday, April 9, 2024
Data monitoring committee, Cirrhosis, Metabolism, Disease, Risk, Patient, Hope, MASH, Final Analysis, Therapy, GALT, Safety, DSMB, Interim, Plasma protein binding, Esophageal varices, Liver, Pharmaceutical industry

The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.

Key Points: 
  • The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.
  • Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications.
  • The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial.
  • Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo.

NurExone Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, April 2, 2024
ODD, Research, Growth, Drug discovery, Exercise, NRX, CFO, RNA, Laboratory, Contract research organization, Regenerative medicine, Investigational New Drug, Safety, Spinal cord injury, Intellectual property, Plasma protein binding, Small RNA, FDA, Food, Cryptocurrency

TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.

Key Points: 
  • TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.
  • For the fourth quarter of 2023, expenses were US$0.31 million, compared to US$0.39 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.40 million, compared to US$0.46 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.02 million, compared to US$0.17 million in the previous year.

Avicanna Announces the Canadian Launch of 10% CBD (THC Free) Proprietary Formulation

Retrieved on: 
Wednesday, March 27, 2024
Cannabinoid, Absorption, Dravet syndrome, Seizure, Lennox–Gastaut syndrome, Patient, Research, CBD, Health Canada, TSX, THC, Plasma protein binding, RHO

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada. RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology. RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.

Key Points: 
  • TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada.
  • RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology.
  • RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.
  • RHO Phyto Micro Drop 100 contains the same proprietary oral formulation as the product Trunerox™.

Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2023 and Business Highlights

Retrieved on: 
Tuesday, March 26, 2024
Research, Toxicity, Central nervous system, PIN, Administration, Immunotherapy, Emax, Science, Patient, AstraZeneca, Food and Drug Administration, Biomarker, G&A, Plaque, Chemistry, Therapy, Neurogranin, Safety, ABOS, Research and development, Plasma protein binding, Food, Pharmaceutical industry

We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.

Key Points: 
  • We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.
  • We also expect to initiate a subcutaneous bioavailability study in mid-2024, to extend the product profile and offer administration optionality for patients.
  • Dr. Doherty brings decades of neuroscience-focused research and clinical development expertise to Acumen, from discovery through drug approval.
  • Net loss for the year ended December 31, 2023 was $52.4 million, compared to a net loss of $42.9 million for the year ended December 31, 2022.

Amidst Medicaid Unwinding, 80% of Free Clinics are Experiencing an Increase in Demand

Retrieved on: 
Tuesday, March 26, 2024
Patient, Pharmacy, Volunteering, Insurance, NAFC, Poverty, Plasma protein binding, Safety, National Association, Pharmaceutical industry

In total, 80% of free clinics experienced an increase in patient demand in 2023, a steady increase from 73% in 2022 and 68% in 2021.

Key Points: 
  • In total, 80% of free clinics experienced an increase in patient demand in 2023, a steady increase from 73% in 2022 and 68% in 2021.
  • Free and charitable clinics are the safety net for those who slip through the coverage gap, with 82% of their patient populations being uninsured.
  • 190,000 individuals volunteered at free and charitable clinics and pharmacies across the country last year, but the need for specialized care is only increasing.
  • Survey results showed that most free clinics and pharmacies across the country purchase medications on behalf of their patients using their own budgets.

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

Retrieved on: 
Monday, April 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

Muscular Dystrophy Association’s Funding of Foundational Research Leads to New FDA Approved Treatment Duvyzat (givinostat) for Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, March 21, 2024
HDAC, Gene expression, Cell, Disease, MDA, Associate, Patient, Research, DNA, Public policy, University, Muscular dystrophy, Doctor of Philosophy, Muscular Dystrophy Association, Duchenne muscular dystrophy, Clinical trial, Therapy, Histone deacetylase inhibitor, Stair climbing, Plasma protein binding, FDA, Steroid, DMD, Parent, Lancet, Pediatrics, Human, Food, Pharmaceutical industry

"The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA.

Key Points: 
  • "The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA.
  • “Muscular Dystrophy Association’s funding was fundamental for the discovery of HDACi in the treatment of Duchenne muscular dystrophy.
  • “We’re excited to celebrate this additional treatment option for people living with Duchenne muscular dystrophy.
  • My son is an example,” said Jessica Curran, MDA family member and mother of Conner who lives with Duchenne muscular dystrophy.

Lively HSA Account Holders Boast 2x Investing and 17% Higher Account Balances Than Industry Average

Retrieved on: 
Thursday, April 4, 2024
Technology, Professional Services, Managed Care, Other Health, Health, Health Insurance, Asset Management, Software, Fintech, Human Resources, Finance, Health savings account, Mental health, Customer, Human services, Investment, Plasma protein binding, Habit, HSA, Multimedia

Lively, Inc., a top-rated health and lifestyle benefits platform* known for creating the modern Health Savings Account (HSA), today announces the release of its sixth annual HSA Snapshot report, which tracks HSA account holders’ saving, spending, and investing.

Key Points: 
  • Lively, Inc., a top-rated health and lifestyle benefits platform* known for creating the modern Health Savings Account (HSA), today announces the release of its sixth annual HSA Snapshot report, which tracks HSA account holders’ saving, spending, and investing.
  • Lively’s annual account balance of funded accounts is $4,885, which is 17% higher than the industry average of $4,177.
  • Investments drive HSA balance growth and Lively account holders invest nearly 2x the industry average.
  • Despite increased withdrawal activity, Lively account holders retain more of their HSA assets than the industry average at 25% compared to 23% industry wide.

Drug Prices Decline Thanks to President Biden, Notes AHF

Retrieved on: 
Saturday, March 30, 2024
Advocacy Group Opinion, Public Policy, Government, Healthcare Reform, Philanthropy, White House, Federal Government, AIDS, Pharmaceutical, Health, Foundation, Other Policy Issues, IRA, AIDS Healthcare Foundation, Federation, Plasma protein binding, AHF, Medicare, Inflation, Pharmaceutical industry

AIDS Healthcare Foundation (AHF) applauds the Biden administration’s continued efforts to lower prescription drug prices for all Americans.

Key Points: 
  • AIDS Healthcare Foundation (AHF) applauds the Biden administration’s continued efforts to lower prescription drug prices for all Americans.
  • Multiple provisions in the law bend the prescription drug cost curve down.
  • The U.S. Department of Health and Human Services announced that over 763,000 Medicare beneficiaries will start seeing lower drug prices beginning April 1.
  • “The Medicare Prescription Drug Inflation Rebate Program, the provision responsible for the much-needed savings, slows the rise of prescription drug price increases and shores up the Medicare trust fund.

Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder

Retrieved on: 
Wednesday, March 13, 2024
Alternative Medicine, Mental Health, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, JAMA, Depression, Disability, Conference, BTD, Breakthrough therapy, Massachusetts General Hospital, Inc., Psychiatry, Clinical, Grammatical mood, Appetite, MDD, Data analysis, Patient, Knowledge, Disease, Causality, Sleep, Anhedonia, DNB, DSM-IV codes, MBBS, Suicidal ideation, Behavior, Cognition, Event, Hospital, Drug development, Safety, Injury, Multimedia, Plasma protein binding, Sadness, Lancet, BMJ, Pharmaceutical industry

If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.

Key Points: 
  • If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
  • The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies.
  • With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously.
  • (2022) Response to acute monotherapy for major depressive disorder in randomized, placebo-controlled trials submitted to the US Food and Drug Administration: individual participant data analysis.