PDE5

Can-Fite Received Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602

Retrieved on: 
Monday, May 6, 2024
Professional Services, Oncology, Patent Law, Health, Pharmaceutical, Biotechnology, Use, IP, European Patent Convention, Diabetes, A3, Erectile dysfunction, ICM, Patent, Patient, Vardenafil, Inflammation, Sildenafil, Tadalafil, ED, CANF, PDE5, Pharmaceutical industry

Can-Fite recently published an article in Andrologia , suggesting that CF602 could potentially offer an alternative to the current drugs on market.

Key Points: 
  • Can-Fite recently published an article in Andrologia , suggesting that CF602 could potentially offer an alternative to the current drugs on market.
  • A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function.
  • “This additional European patent for erectile dysfunction adds to our growing IP estate for this high-value indication of the CF602 drug candidate.
  • The Erectile Dysfunction market is expected to reach approximately $6.6 billion by 2030, according to Market Research Future.

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Friday, March 22, 2024
Diagnosis, ESC, Toxicity, ERA, Tadalafil, Internal medicine, European Respiratory Society, Disease, Risk, Pulmonary hypertension, Patient, PVR, Mitigation, Female, Nitric oxide, Connective tissue disease, Orthostatic hypertension, World Health Organization, PDE5, Johnson & Johnson, REMS, WHO, Pulmonary circulation, PAH, FDA, Constriction, ERS, Food, Pharmaceutical industry

RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

Nicox announces presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024

Retrieved on: 
Tuesday, February 6, 2024
Mont Blanc, IOP, Intraocular pressure, Research, PDE5, Glaucoma, Patient, Dog, Nitric oxide, NCX, Laser, Rabbit, Retina, Ocular hypertension, ARVO

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced presentations on NCX 470 and NCX 1728 at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, a key ophthalmology conference which will be held from May 5 to May 9, 2024 in Seattle, WA, United States.

Key Points: 
  • Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced presentations on NCX 470 and NCX 1728 at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, a key ophthalmology conference which will be held from May 5 to May 9, 2024 in Seattle, WA, United States.
  • Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been announced in October 2022.
  • The second Phase 3 clinical trial, Denali, is currently ongoing, and the results are expected in 2025, based on current recruitment rates.
  • The Company estimates it is financed until June 2024, based exclusively on the development of NCX 470.

Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024

Retrieved on: 
Monday, January 8, 2024
DED, HSDD, Probability, Sale, PDE5, Weight loss, UC, Trial of the century, PTN, Calendar, Obesity, Patient, Therapy, Female, Diabetic nephropathy, Erectile dysfunction, Pharmaceutical industry

"We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.

Key Points: 
  • "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.
  • Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024.
  • We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024.
  • The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline.

New Guidelines on Men with Erectile Dysfunction and Cardiac Health Published in the Journal of Sexual Medicine Concludes PDE-5 Inhibitors are Still Safe for the Cardiovascular System

Retrieved on: 
Thursday, January 4, 2024
Research, Seniors, Men, Cardiology, Biotechnology, Health, Consumer, Pharmaceutical, Science, Patient, Exercise, HMRI, ED, Risk, Nitrate, Woman, PDE5, Hypotension, Moyamoya disease, B cell, Mortality, Regenerative medicine, Pharmacist, Platelet-rich plasma, MBA, MD, Doctor of Philosophy, Huntington Medical Research Institutes, Pulmonary hypertension, Tadalafil, University, CVD, Death, CAC, System, CT scan, Oxygen, American College, Contra, Overalls, Dietary supplement, Princeton University, Ischemia, Journal, Female, Johns Hopkins, Erectile dysfunction, Pharmaceutical industry

Their summary and guidelines have now been published in the Journal of Sexual Medicine.

Key Points: 
  • Their summary and guidelines have now been published in the Journal of Sexual Medicine.
  • They determined that PDE-5 inhibitors are still safe for the cardiovascular system.
  • The conference was funded by an unrestricted grant from Sanofi to readdress the cardiovascular workup of men presenting with ED and the cardiovascular safety of the phosphodiesterase-5 (PDE-5) inhibitors for treating ED.
  • Patients with ED should be characterized as low-risk, intermediate (or indeterminable), or high-risk of developing a cardiac event with sexual activity.

Human medicines European public assessment report (EPAR): Levitra, vardenafil, Date of authorisation: 06/03/2003, Revision: 33, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Fungal infection, Medical Subject Headings, Marketing, European Commission, Liver, INN, Nitrate, Woman, Allergy, PDE5, Pelvic floor dysfunction, ATC, Hypotension, Itraconazole, International, Man, European, Headache, Ageing, Language, Blood, CGMP, Mouth, Eye, Pulmonary hypertension, Erectile dysfunction, Stroke, Kidney, Kidney disease, Angina, Ketoconazole, HIV, Ritonavir, Tablet, Indinavir, Select, Committee, Patient, Penis, Liver disease, Risk management, Anatomy, Medicine, Dialysis, IIA, Diabetes, CHMP, Medical device

Human medicines European public assessment report (EPAR): Levitra, vardenafil, Date of authorisation: 06/03/2003, Revision: 33, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Levitra, vardenafil, Date of authorisation: 06/03/2003, Revision: 33, Status: Authorised

New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023

Retrieved on: 
Wednesday, April 26, 2023
Mont Blanc, NCX, Retina, Glaucoma, Erosion (morphology), ARVO, IOP, Nitric oxide, PDE5, Ischemia-reperfusion injury of the appendicular musculoskeletal system, NDA, Ocular hypertension, Euronext Paris, NO, HIV disease progression rates, Patient, Sickle cell retinopathy, Annual general meeting, Rabbit, Association for Research in Vision and Ophthalmology, Research, COX, Safety, Telescopic sight, Pharmaceutical industry, Ophthalmology, New Data Seal

New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023

Key Points: 
  • New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023
    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that studies highlighting nonclinical data on NCX 470 and NCX 1728 have been presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2023 being held April 23-27, 2023 in New Orleans, LA, United States.
  • Effectively managing the ocular blood flow may slow the progressive worsening of retinal cell function seen in glaucoma patients.
  • This work shows compelling new evidence of retinal cell protective activity with NCX 470 in addition to its IOP lowering ability.
  • Specifically, NCX 470 is found to reverse both hemodynamic and retinal cell impairments consequent to ET-1 induced ischemia/reperfusion injury in rabbits.

AriBio Co., Ltd. to Present Biomarker Data for AR1001 from the Mild to Moderate Alzheimer’s Disease Phase 2 Study at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2023)

Retrieved on: 
Friday, March 31, 2023
Biotechnology, Neurology, Mental Health, Health, Pharmaceutical, Cognition, GFAP, Autophagy, PDE5, Neurogenesis, AFL, Plasma, Patient, Apoptosis, Simoa, CSF, Safety, Pharmaceutical industry

The phase 2 study was a double-blind, randomized, placebo-controlled, multi-center trial to evaluate the safety and preliminary efficacy of AR1001 over 26 and 52 weeks of treatment in patients with mild to moderate Alzheimer’s disease.

Key Points: 
  • The phase 2 study was a double-blind, randomized, placebo-controlled, multi-center trial to evaluate the safety and preliminary efficacy of AR1001 over 26 and 52 weeks of treatment in patients with mild to moderate Alzheimer’s disease.
  • AriBio initiated a phase 3 pivotal trial with 30mg of AR1001 to be administered daily to early and mild Alzheimer’s disease patients in December of 2022.
  • “This biomarker data helps bolster the positive effects seen in cognition with the high dose of AR1001 in the Phase 2 study in mild AD patients.
  • We will continue to collect both CSF and plasma as part of the phase 3 study to analyze as supportive data,” stated Dr. Greeley.

AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Strategic Partnership to Advance Biomarker Development for Alzheimer’s Disease and Neurodegeneration

Retrieved on: 
Wednesday, March 8, 2023
Neurology, Biotechnology, Pharmaceutical, General Health, Health, Mental Health, Clinical Trials, Other Health, DSM-IV codes, Diagnosis, Neurodegenerative disease, Biomarker, Autophagy, Partnership, Patient, Apoptosis, Multimedia, Diversified Specialty Institute Holdings, Inc., PDE5, FDA, Organization, Fujirebio, Neurogenesis, CSF, Pharmaceutical industry

Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced a strategic partnership to advance the development of biomarkers for Alzheimer’s disease and other neurodegenerative conditions.

Key Points: 
  • Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced a strategic partnership to advance the development of biomarkers for Alzheimer’s disease and other neurodegenerative conditions.
  • The agreement provides Fujirebio access to clinical samples and data collected as part of the ongoing Phase 3 Alzheimer’s disease study launched by AriBio in Dec. 2022.
  • Fujirebio, a trusted partner for high-quality IVD testing solutions and a pioneer in neurodegenerative disease diagnostics is committed to the advancement of biomarkers to improve diagnosis of Alzheimer’s disease.
  • Fujirebio continues to make advances in the field to provide fully automated blood-based tests for Alzheimer’s disease and other neurological disorders.

Nicox to Present at Upcoming Scientific Conferences

Retrieved on: 
Friday, March 3, 2023
Mont Blanc, Safety, Glaucoma, Annual general meeting, AGS, American Glaucoma Society, Nitric oxide, Ischemia-reperfusion injury of the appendicular musculoskeletal system, Association for Research in Vision and Ophthalmology, Intraocular pressure, Patient, Research, Rabbit, Retina, PDE5, Erosion (morphology), COX, IOP, NO, NCX, Denali, Euronext Paris, State University of New York Upstate Medical University, Ocular hypertension, ARVO, Pharmaceutical industry, Clothing, Telescopic sight, Ophthalmology, Latanoprost

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a number of presentations at key ophthalmology conferences including the American Glaucoma Society (AGS) Annual Meeting 2023 and the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2023.

Key Points: 
  • Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a number of presentations at key ophthalmology conferences including the American Glaucoma Society (AGS) Annual Meeting 2023 and the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2023.
  • The first randomized, double-masked, multi-center, parallel group trial conducted in the United States (Mont Blanc) comparing NCX 470 (0.1%) to latanoprost (0.005%) was completed in October 2022.
  • The second Phase 3 trial Denali, similarly designed to Mont Blanc, and which includes a long-term safety extension, is ongoing.
  • NCX 1728 is an NO-donating phosphodiasterase type-5 (PDE5) inhibitor under preclinical evaluation for development in retinal conditions.