Fibromyalgia

Tonix Pharmaceuticals Announces Proposed Public Offering

Retrieved on: 
Thursday, July 27, 2023
Long COVID, Prader–Willi syndrome, Sumatriptan, Failure, Telephone, Drug Master File, Autoimmunity, Pain, Acquisition, Madison Avenue, Psychiatry, Therapy, Capital market, SL, Research, Infection, Risk, Orphan drug, Security (finance), FDA, COVID-19, Cancer, Smallpox, Disease, Government, Breakthrough therapy, Hydrogen chloride, MDD, Annual report, Neurology, Form, CD40L, Central nervous system, CNS, Sale, Prospectus, S-3, DSM-IV codes, Nature, Fibromyalgia, Pharmaceutical industry, CD154, Tonix Pharmaceuticals

CHATHAM, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.

Key Points: 
  • CHATHAM, N.J., July 27, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.
  • All of the securities to be sold in the offering are to be offered by Tonix.
  • The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
  • Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-placement agent for the offering.

Tonix Pharmaceuticals Announces Accelerating Completion of Enrollment in Phase 2 UPLIFT Study of TNX-601 ER (Racemic Tianeptine) for Major Depressive Disorder: Topline Data Now Expected in Fourth Quarter 2023

Retrieved on: 
Wednesday, July 26, 2023
Tianeptine, Cognition, Psychiatry, Neuron, Tonix Pharmaceuticals, NOR, DSM-IV codes, Bipolar disorder, PPAR, SL, Brain, MDD, Patient, Patent, Norepinephrine, RDC, Fibromyalgia, Mouse, Serotonin, Research, IND, Memory, Atrophy, Asian Pacific Development Center, Pharmaceutical industry, Depression

CHATHAM, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced that development of TNX-4300* (estianeptine), the single (S)-isomer of tianeptine will be prioritized over TNX-601 ER*, which is being studied in the Phase 2 UPLIFT1 trial for the treatment of major depressive disorder (MDD). TNX-4300 is in preclinical development for mood disorders, Alzheimer’s disease and Parkinson’s disease. Recent findings have shown estianeptine possesses the ability to improve memory and cognition in vivo as measured in the rat Novel Object Recognition (NOR) test, and the ability to restore neuroplasticity to neurons in cell culture. The finding that estianeptine is responsible for improving memory and cognition in vivo suggests a role for peroxisome proliferator-activated receptor PPAR-β/δ activation in memory. For these reasons, Tonix intends to accelerate completion of enrollment for the Phase 2 UPLIFT1 trial to reallocate resources to the preclinical development of TNX-4300 and now expects to report topline data from this study in the fourth quarter of 2023. Tonix is also accelerating completion of enrollment in the RESILIENT study of TNX-102 SL for the management of fibromyalgia so that approximately 450 patients will be enrolled, and topline results are expected in the fourth quarter of 2023.

Key Points: 
  • The finding that estianeptine is responsible for improving memory and cognition in vivo suggests a role for peroxisome proliferator-activated receptor PPAR-β/δ activation in memory.
  • For these reasons, Tonix intends to accelerate completion of enrollment for the Phase 2 UPLIFT1 trial to reallocate resources to the preclinical development of TNX-4300 and now expects to report topline data from this study in the fourth quarter of 2023.
  • Tonix is also accelerating completion of enrollment in the RESILIENT study of TNX-102 SL for the management of fibromyalgia so that approximately 450 patients will be enrolled, and topline results are expected in the fourth quarter of 2023.
  • Racemic tianeptine is an antidepressant that has been marketed outside the U.S. for more than 30 years.

Former Severe Fibromyalgia Patient Challenges Others to Empowerment with New Data Service

Retrieved on: 
Tuesday, July 25, 2023
Fibromyalgia, Data science, Human, The Hardship Diaries, GxP, Annual report, Freedom, Management, Online shopping

The mission of the experiment is to provide members with insights into their day to day.

Key Points: 
  • The mission of the experiment is to provide members with insights into their day to day.
  • Thomasino was diagnosed with severe fibromyalgia after an unexpected accident falling down 15 feet of stairs.
  • She has since become a twenty-two-time author, 2x CEO, worked on a congressionally recognized healthcare campaign, and is an inspiring public speaker.
  • Through these initiatives, she hopes that more people will be inspired by her story of resilience and determination while gaining access to valuable market research insights through her data service.

Center for Disease Analysis Foundation Announces Receipt of an $8 Million Grant from Gilead Sciences to Relink Hepatitis B and C Patients to Care in the United States

Retrieved on: 
Thursday, July 20, 2023
Lymphoma, Infection, Insulin resistance, Gilead Sciences, Medicaid, Medical Affairs Bureau, Depression, Partnership, Office of Inspector General, U.S. Department of Health and Human Services, Diabetes, HIV, Vaccination, Arthritis, Liver disease, Human services, Public, COVID-19, Cancer, Deficit spending, Quality of life, Hepatitis B virus, Research, Medicine, Kidney, Gilead, Liver cancer, CDC, Organization, CDA, Patient, Risk, Fibromyalgia, U.S. CDC, WHO, Liver failure, Viral hepatitis, Cirrhosis, HBV, HCV, Virus, World Health Organization, Fatigue, Pharmaceutical industry, Vaccine, Medicare, Granblue Fantasy: Relink

LAFAYETTE, Colo., July 20, 2023 (GLOBE NEWSWIRE) -- The Center for Disease Analysis Foundation (CDA Foundation) announced today that it received an $8 million grant from Gilead Sciences (Nasdaq: GILD) as part of Gilead’s Relink grant program.

Key Points: 
  • LAFAYETTE, Colo., July 20, 2023 (GLOBE NEWSWIRE) -- The Center for Disease Analysis Foundation (CDA Foundation) announced today that it received an $8 million grant from Gilead Sciences (Nasdaq: GILD) as part of Gilead’s Relink grant program.
  • CDA Foundation will disperse the grant to qualifying tax-exempt organizations to contact diagnosed but untreated patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection to bring them back into care.
  • Both viruses are responsible for increasing rates of cirrhosis, liver cancer, liver failure and premature deaths.
  • The Relink grant program aims to identify and work to bridge the gaps that remain in linking patients back to necessary care and treatment.

Center for Disease Analysis Foundation Announces Receipt of an $8 Million Grant From Gilead Sciences to Relink Hepatitis B and C Patients to Care in the United States

Retrieved on: 
Thursday, July 20, 2023
Health, Foundation, Philanthropy, Managed Care, Oncology, Lymphoma, Infection, Insulin resistance, Gilead Sciences, Medicaid, Medical Affairs Bureau, Depression, Partnership, Office of Inspector General, U.S. Department of Health and Human Services, Diabetes, HIV, Vaccination, Arthritis, Liver disease, Human services, Public, COVID-19, Cancer, Deficit spending, Quality of life, Hepatitis B virus, Research, Medicine, Kidney, Gilead, Liver cancer, CDC, Organization, CDA, Patient, Risk, Fibromyalgia, U.S. CDC, WHO, Liver failure, Viral hepatitis, Cirrhosis, Virus, HBV, HCV, World Health Organization, Fatigue, Pharmaceutical industry, Vaccine, Medicare

The Center for Disease Analysis Foundation (CDA Foundation) announced today that it received an $8 million grant from Gilead Sciences (Nasdaq: GILD) as part of Gilead’s Relink grant program.

Key Points: 
  • The Center for Disease Analysis Foundation (CDA Foundation) announced today that it received an $8 million grant from Gilead Sciences (Nasdaq: GILD) as part of Gilead’s Relink grant program.
  • CDA Foundation will disperse the grant to qualifying tax-exempt organizations to contact diagnosed but untreated patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection to bring them back into care.
  • Both viruses are responsible for increasing rates of cirrhosis, liver cancer, liver failure and premature deaths.
  • The relink grant program aims to identify and work to bridge the gaps that remain in linking patients back to necessary care and treatment.

Gupta Program: New Research Shows Amygdala & Insula Retraining (AIR) Significantly Reduces Long Covid Fatigue

Retrieved on: 
Wednesday, July 19, 2023
Myenteric plexus, COVID-19, Fatigue, Research, Brain, Timeline of the COVID-19 pandemic in the United Kingdom, Amygdala, Patient, AIR, Chronic fatigue syndrome, Vaccine, Pharmaceutical industry, Long COVID, Fibromyalgia

LONDON, July 19, 2023 /PRNewswire/ -- A promising medical study has just been published, offering hope for those grappling with the long-term effects of Covid-19. Long Covid, the often-overlooked and persistent consequence of the global pandemic, continues to affect a significant number of individuals worldwide, even as it has receded from the public consciousness.

Key Points: 
  • The study examined the efficacy of the Gupta Program , a pioneering neuroplasticity-based treatment, in significantly reducing fatigue and increasing energy levels among Long Covid patients, when compared to a general wellness program.
  • The report's findings are from a randomized controlled study, titled "Amygdala and Insula Retraining (AIR) Significantly Reduces Fatigue in People with Long COVID," published in the Evidence-Based Complementary and Alternative Medicine Journal.
  • It is the first peer-reviewed study demonstrating the effectiveness of a neuroplasticity brain retraining program in addressing Long Covid-induced prolonged fatigue.
  • The study employed a methodology to assess the impact of the Gupta Program on Long Covid symptoms.

Virios Therapeutics Announces Positive Data Demonstrating Improvement in Multiple Long-COVID Symptoms Following Treatment with a Combination of Valacyclovir and Celecoxib in an Exploratory, Open-Label, Proof of Concept Study

Retrieved on: 
Monday, July 17, 2023
PROMIS, Myalgia, NRS, Brookings Institution, Arthralgia, Headache, Female, FM, Overalls, Health status of Asian Americans, Celecoxib, BHC, COVID, Doctor of Philosophy, Fatigue, Pain, Food and Drug Administration Amendments Act of 2007, Long COVID, Medical director, COVID-19, Patient, Center of excellence, Dysautonomia, Fibromyalgia, Nausea, Conditional sentence, Diagnosis, Health, Therapy, PASC, Valaciclovir, Food, Post-exertional malaise, Pharmaceutical industry, MD

This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.

Key Points: 
  • This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.
  • Treatment with Val/Cel was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib.
  • There were no serious adverse events observed in this study and only one treated patient discontinued treatment due to adverse events, possibly related to Val/Cel treatment.
  • “We look forward to engaging the Food and Drug Administration to discuss progressing this novel treatment option into active Phase 2 clinical development.”

Return Healthy Launches Revolutionary Cell Stabilization Line of Supplements

Retrieved on: 
Tuesday, July 11, 2023
Radical, Diabetes, Infection, COVID-19, Ageing, Nutrient, Vitamin E, Phospholipid, Cell, Inflammation, The Non-GMO Project, Inner mitochondrial membrane, Knowledge, Cauchy stress tensor, Health, Fatigue, Vaccine, Phosphorus, Fibromyalgia

St. George, Utah, July 11, 2023 (GLOBE NEWSWIRE) -- Return Healthy, a premier natural supplement company, has announced the launch of its revolutionary Cell Stabilization line of supplements.

Key Points: 
  • St. George, Utah, July 11, 2023 (GLOBE NEWSWIRE) -- Return Healthy, a premier natural supplement company, has announced the launch of its revolutionary Cell Stabilization line of supplements.
  • This line is designed to help people fight the effects of aging, stress, and environmental toxins on their cells.
  • “We are excited to introduce our Cell Stabilization line of supplements that will provide an effective solution for those looking to combat the effects of aging, stress, and environmental toxins on their cells,” said Dr. Werner Vosloo, founder and Clinical Director of Return Healthy.
  • Reversing cell disease responses and optimizing cell structure leads to healthy cellular function, and this is imperative in order to stay healthy during these challenging times we live in today.

NeuroMetrix Announces Sales Force Expansion for Quell Fibromyalgia

Retrieved on: 
Tuesday, July 11, 2023
Contraindication, TENS, Label, Sleep, Sale, Patient, Physician, Fibromyalgia, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

WOBURN, Mass., July 11, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today announced expansion of its sales force to drive further adoption of Quell® Fibromyalgia, which is the first and only medical device authorized by the U.S. Food and Drug Administration (FDA) to help reduce the symptoms of fibromyalgia.

Key Points: 
  • WOBURN, Mass., July 11, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today announced expansion of its sales force to drive further adoption of Quell® Fibromyalgia, which is the first and only medical device authorized by the U.S. Food and Drug Administration (FDA) to help reduce the symptoms of fibromyalgia.
  • This expansion follows positive results from the strategic launch of Quell Fibromyalgia in December 2022, and is designed to intensify commercial efforts in the California, Texas and Florida markets.
  • “We are encouraged by the response to Quell Fibromyalgia from physicians and patients during our strategic launch phase,” said Shai N. Gozani, M.D., Ph.D., Chief Executive Officer of NeuroMetrix.
  • The sale, distribution, and use of Quell Fibromyalgia is restricted to prescription use in accordance with 21 CFR 801.109.

Tonix Pharmaceuticals Comments on Two Long COVID Conferences Sponsored by the U.S. National Academies

Retrieved on: 
Thursday, July 6, 2023
Database, Tonix Pharmaceuticals, Arthralgia, Cluster analysis, SARS-CoV-2, National Academies of Sciences, Engineering, and Medicine, Sleep, DSM-IV codes, SL, Infection, COVID, Bangladesh Technical Education Board, Quality, Pain, Myalgia, National academy, Back pain, Nociplastic pain, Hydrogen chloride, Translational medicine, Patient, Quality of life, Motivation, Fibromyalgia, National Institute of Allergy and Infectious Diseases, NIAID, Research, FDA, CFS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Fatigue, Pharmaceutical industry, Long COVID, Engineering, Medicine

CHATHAM, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced comments relating to two recent meetings sponsored by the National Academies of Sciences, Engineering, and Medicine (National Academies) in Washington, D.C. and virtually, relating to the definition of Long COVID and to features of Long COVID that overlap with previously recognized infection-associated chronic conditions. The first meeting, “Examining the Working Definition for Long COVID”1, took place on June 22 and 23, and the second, “Toward a Common Research Agenda in Infection-Associated Chronic Illnesses”2 took place on June 29 and 30. Tonix Pharmaceuticals recognizes the potential benefits of defining subgroups of Long COVID patients based on their symptoms and recognizes the subgroup of Long COVID patients with symptoms that overlap with fibromyalgia. Tonix’s experience advancing TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* as a treatment for fibromyalgia is the Company’s motivation for undertaking the development of TNX-102 SL for the management of Fibromyalgia-type Long COVID.

Key Points: 
  • CHATHAM, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced comments relating to two recent meetings sponsored by the National Academies of Sciences, Engineering, and Medicine (National Academies) in Washington, D.C. and virtually, relating to the definition of Long COVID and to features of Long COVID that overlap with previously recognized infection-associated chronic conditions.
  • Tonix Pharmaceuticals recognizes the potential benefits of defining subgroups of Long COVID patients based on their symptoms and recognizes the subgroup of Long COVID patients with symptoms that overlap with fibromyalgia.
  • Tonix’s experience advancing TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* as a treatment for fibromyalgia is the Company’s motivation for undertaking the development of TNX-102 SL for the management of Fibromyalgia-type Long COVID.
  • We believe Cluster #4 is a subgroup of Long COVID that overlaps with fibromyalgia.