Peripheral nervous system

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Friday, December 15, 2023
Pharmaceutical, Science, Health, Research, Peripheral nervous system, European Commission, European Academy of Neurology, Research and development, Chronic inflammatory demyelinating polyneuropathy, European Medicines Agency, Disease, Clinical trial, EMA, Patient, European, CHMP, Marketing, Committee, Caregiver, Advanced Therapy Medicinal Product, CIDP, Neurology, Recombinant, IGS, IVIG, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
  • This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.
  • HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.

The Paul G. Allen Frontiers Group announces Allen Discovery Center for Neuroimmune Interactions at Icahn School of Medicine at Mount Sinai

Retrieved on: 
Thursday, November 9, 2023
Allergy, Nervous system, Inflammation, Icahn School of Medicine at Mount Sinai, Allen Institute, Innovation, Health, Autoimmunity, Physiology, Skin, Infection, NYU, Metabolism, Inflammatory bowel disease, Lung, ADC, Disease, Yale University, Immune system, Paul G. Allen Frontiers Group, Biology, Immunity, Sensation, Peripheral nervous system, Partnership, Nutrition, Brain, Cancer, Neuroinflammation, Weill Cornell Medicine, Map, Pharmaceutical industry, Research, Dermatology, Science, Medicine

SEATTLE, Nov. 9, 2023 /PRNewswire/ -- The Paul G. Allen Frontiers Group, a division of the Allen Institute, today announced the launch of the Allen Discovery Center (ADC) for Neuroimmune Interactions at the Icahn School of Medicine at Mount Sinai. The research team will comprehensively define and map the interactions between the nervous system and the immune system that take place distant from the brain, such as at the skin, lung, and gut surfaces, and analyze how these interactions relay a variety of sensations back to the brain and regulate organ physiology and tissue immune responses.

Key Points: 
  • A multidisciplinary research center to define, map, and understand the health consequences of interactions between the nervous system and the immune system
    SEATTLE, Nov. 9, 2023 /PRNewswire/ -- The Paul G. Allen Frontiers Group, a division of the Allen Institute, today announced the launch of the Allen Discovery Center (ADC) for Neuroimmune Interactions at the Icahn School of Medicine at Mount Sinai.
  • The Center will bring together cutting-edge research from the worlds of neuroscience and immunology.
  • This Allen Discovery Center is led by Dr. Brian S. Kim of Mount Sinai and Dr. David Artis of Weill Cornell Medicine.
  • The Allen Discovery Center for Neuroimmune Interactions is funded at $10 million over four years by the Paul G. Allen Family Foundation, with a total potential for $20 million over eight years.

Autonomix Medical, Inc. Launches Social Media Channels

Retrieved on: 
Wednesday, November 8, 2023
Peripheral nervous system, Nervous system, Social media, News, Pancreatitis, Disease, Clinical trial, Pancreatic cancer, Pain, Patient, Pharmaceutical industry, Medical imaging

THE WOODLANDS, TX, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (“Autonomix” or the “Company”) a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the launch of its new corporate social media channels. To stay up to date with Autonomix’s latest news and events, connect with the Company on Twitter, LinkedIn and Facebook.

Key Points: 
  • THE WOODLANDS, TX, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (“Autonomix” or the “Company”) a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the launch of its new corporate social media channels.
  • “We believe Autonomix represents an exciting opportunity to potentially revolutionize how diseases involving the nervous system are diagnosed and treated.
  • Autonomix is designing technology to detect these faint signals, paving the way for targeted treatment not yet available in the market today.
  • Ultimately, the Autonomix technology may be used to potentially treat a large number of diseases relating to nervous system function.

IGC Pharma Granted European Patent for Groundbreaking Cannabinoid-Based Pain Topical Relief Therapy

Retrieved on: 
Thursday, October 19, 2023
Mental Health, Women, Seniors, Cannabis, Alternative Medicine, Health, Consumer, Pharmaceutical, Natural Resources, Patient, Ageing, The Journal of Pain, Patent, NYSE, Human, Pharma, Journal, Quality of life, IGC, European Patent Office, Peripheral nervous system, THC, Cannabinoid, Pain management, European Patent Convention, Cannabidiol, Arthritis, Pharmaceutical industry, CBD, Pain

IGC Pharma, Inc. (“IGC,” “IGC Pharma” or the “Company”) (NYSE American: IGC), a visionary clinical-stage pharmaceutical company, is thrilled to announce a significant milestone: the grant of European Patent No.

Key Points: 
  • IGC Pharma, Inc. (“IGC,” “IGC Pharma” or the “Company”) (NYSE American: IGC), a visionary clinical-stage pharmaceutical company, is thrilled to announce a significant milestone: the grant of European Patent No.
  • 3193862 by the European Patent Office (“EPO”) for our innovative "Cannabinoid Composition and Method for Treating Pain."
  • IGC Pharma is at the forefront of innovation, dedicated to enhancing the quality of life and well-being of those in pain.
  • Ram Mukunda, CEO of IGC Pharma, commented, “IGC Pharma is committed to advancing pain relief therapies rooted in decades of rigorous scientific research.

EQS-News: Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Retrieved on: 
Tuesday, October 17, 2023
Incidence, Schizophrenia, LOF, Clinical Global Impression, PANSS, Safety, CEST, Positive, Evenamide, TRS, Strauss, CNS, Peripheral nervous system, Psychosis, Level, XETRA, ECNP, Patient, Pharmaceutical industry, Nursing, Functional neurologic disorder

Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Key Points: 
  • Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
    The issuer is solely responsible for the content of this announcement.
  • 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
  • In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
  • Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.

Newron TRS Study 6 Months’ Results: Evenamide Substantially Improves Patients to an Extent That They No Longer Meet Protocol Entry Criteria

Retrieved on: 
Monday, October 9, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Incidence, Schizophrenia, LOF, Clinical Global Impression, PANSS, Safety, CEST, Positive, TRS, Strauss, Medication, CNS, Peripheral nervous system, Psychosis, XETRA, ECNP, Patient, Pharmaceutical industry, Nursing

95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.

Key Points: 
  • 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
  • In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
  • Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.
  • These results have expedited the design of a potentially pivotal, Phase III randomized, double-blind, placebo-controlled study of two doses of evenamide (15 and 30 mg bid) as an add-on treatment in patients with TRS.

Newron to Present Three Posters on Its Clinical Program Evaluating Evenamide in the Treatment of Schizophrenia at the 36th European College of Neuropsychopharmacology Congress

Retrieved on: 
Wednesday, October 4, 2023
Health, Neurology, Other Science, General Health, Science, Pharmaceutical, Biotechnology, CINP, Schizophrenia, TRS, XETRA, Clozapine, Medication, Congress, European College of Neuropsychopharmacology, Patient, ECNP, SIRS, Peripheral nervous system, Pharmaceutical industry, Newron Cup

Full results from all 161 patients who were randomized in study 014 and who completed six months of participation in study 015 will be presented.

Key Points: 
  • Full results from all 161 patients who were randomized in study 014 and who completed six months of participation in study 015 will be presented.
  • Study 015 is an international, randomized, open-label, rater-blinded, phase II extension study of evenamide as an add-on therapy to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS, not responding to their current antipsychotic medication.
  • Newron presented the data from all 161 patients at the six-week time point and data from the first 100 patients randomized in study 014 who completed one-year of participation in these studies at the 34th CINP World Congress of Neuropsychopharmacology and at the 2023 SIRS Annual Congress in May 2023.
  • The design of a potentially pivotal, international, randomized, double-blind, placebo-controlled, Phase III study aims to demonstrate the efficacy and tolerability of two doses (15 and 30 mg bid) of evenamide as an add-on treatment in TRS patients not benefiting from their current antipsychotic treatment will also be presented at the ECNP.

AlgoTx Announces First Patients Dosed in US and European Arms of Phase II Clinical Trial of ATX01 in Rare Disease Erythromelalgia

Retrieved on: 
Tuesday, September 12, 2023
ACT, Crossover study, Mayo, Chemotherapy-induced peripheral neuropathy, Extremities, Therapy, Face, Safety, Efficacy, Quality of life, Toxicity, Research, CIPN, EMA, Pain, Dermatology, Erythema, Patient, Swelling, EASE, FDA, Skin temperature, Peripheral nervous system, Pharmaceutical industry, Dentistry, Erythromelalgia

Under Orphan Drug Designation from FDA and EMA, this trial investigates the efficacy of the company’s lead asset ATX01 on the pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment.

Key Points: 
  • Under Orphan Drug Designation from FDA and EMA, this trial investigates the efficacy of the company’s lead asset ATX01 on the pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment.
  • I am delighted to be leading the European part of the phase II clinical trial of ATX01.”
    The Mayo Clinic’s Julio Sartori Valinotti MD is involved in the research in the U.S.
  • This condition primarily affects the feet, and less commonly, the hands, arms, legs, ears, and face.
  • It is characterized by intense, burning pain, increases in skin temperature, swelling and severe redness (erythema) of the affected extremities.

Globally Recognized Expert in Rare Neurologic Diseases, Dr. Michael Levy, Joins Trethera Scientific Advisory Board

Retrieved on: 
Tuesday, September 5, 2023
Demyelinating disease, DSM-IV codes, Optic neuritis, Central nervous system, University, Johns Hopkins Hospital, Myelin, Spinal cord, Cancer, Coronavirus Scientific Advisory Board, American Academy, Brain, Inflammation, Multiple sclerosis, Doctor of Philosophy, Associate, MS, Harvard Medical School, Nerve, CNS demyelinating autoimmune diseases, Patient, Division, Optic nerve, ADEM, Baylor College of Medicine, Hospital, Massachusetts General Hospital, American Academy of Neurology, Acute disseminated encephalomyelitis, Peripheral nervous system, Pharmaceutical industry, Philosophy, MD, Neurology

Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.

Key Points: 
  • Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.
  • When the myelin sheath is damaged, nerve impulses slow or even stop, causing neurological problems.
  • “We are honored to have Dr. Levy join our advisory board,” said Dr. Ken Schultz, Chairman and CEO of Trethera.
  • “He is a leading authority on rare neurologic autoimmune diseases and has expertise in both early and late-stage clinical trials.

PANCREATIC CANCER ACTION NETWORK ANNOUNCES RECORD-BREAKING ANNUAL RESEARCH INVESTMENT, INCLUDING NEW GRANT AWARDS, WHICH WILL ACCELERATE PROGRESS AGAINST PANCREATIC CANCER

Retrieved on: 
Wednesday, August 30, 2023
Pancreatic cancer, KRAS, Risk, Pancreatic Cancer Action Network, Biotechnology, Policy, Survival, Therapy, MBA, Research, Mentorship, Biomarker, Doctor of Philosophy, A1C, Protein, Glycine, Patient, JD, Immune system, Vutrisiran, Biology, Neoplasm, Memory, Pancreatic tumor, Disease, Peripheral nervous system, Pharmaceutical industry, Management, Medical imaging

LOS ANGELES, Aug. 30, 2023 /PRNewswire/ -- The Pancreatic Cancer Action Network (PanCAN), a leading nonprofit in the fight against pancreatic cancer, today announced its largest ever single-year research investment—more than $34 million—which includes its large-scale scientific and clinical initiatives and nine new grants.

Key Points: 
  • These funds support PanCAN's priority of finding an early detection strategy and accelerating treatment options for people with pancreatic cancer.
  • "This year marks 20 years of PanCAN awarding research grants – and over that time we have established ourselves as the catalyst for change in the pancreatic cancer community.
  • Since 2003, PanCAN has awarded 236 grants to scientists at 78 institutions around the country, building a comprehensive pancreatic cancer research community.
  • In 1999, when the Pancreatic Cancer Action Network (PanCAN) was founded, there were only a handful of scientists focused on pancreatic cancer, and research funding opportunities were scarce.