Epilepsy

Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan

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Mercoledì, Aprile 17, 2024
Seizure, Marketing, NHI, Eisai, Patient, AMPA, National health insurance, Neurology, AED, Epilepsy, Pharmaceutical industry

TOKYO, Apr 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan.

Key Points: 
  • TOKYO, Apr 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan.
  • The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan's National Health Insurance (NHI) Drug Price List today.
  • Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation.
  • Since Fycompa is the only AMPA receptor antagonist-based AED, Eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and leading to the launch today.

Xenon Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update

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Giovedì, Maggio 9, 2024
FDA, American Academy, Neurocrine Biosciences, Internet, International, WHO, SCN8A, USAN, Nav1.7, World Health Organization, Safety, NDA, PIN, Food, ASCP, Research, Anhedonia, Depression, Webcast, Information technology, IND, INN, OLE, DSM-IV codes, Patient, Society, Epilepsy, Drug discovery, FOS, SCN1A, Ageing, Pharmaceutical industry

VANCOUVER, British Columbia, May 09, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Successful “end-of-Phase 2” interactions with FDA in MDD; Phase 3 program on track to initiate in the second half of the year
    VANCOUVER, British Columbia, May 09, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neuroscience-focused biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.
  • Other income was $11.5 million for the first quarter of 2024, compared to $7.6 million for the same period in 2023.
  • Net loss was $47.9 million for the first quarter of 2024, compared to $41.7 million for the same period in 2023.
  • Xenon will host a conference call and webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss its first quarter results.

NeuroPace Reports First Quarter 2024 Financial Results and Provides Corporate Update

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Mercoledì, Maggio 8, 2024
Investment, Hemispherectomy, Conference, Webcast, RNS, Patient, Responsive neurostimulation device, Rapport, Epilepsy, EEG, Telephone, Growth, Video game

MOUNTAIN VIEW, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • ET --
    MOUNTAIN VIEW, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.
  • Gross margin for the first quarter of 2024 was 73.6% compared to 71.7% in the first quarter of 2023.
  • Net loss was $8.9 million for the first quarter of 2024 compared with $10.4 million in the first quarter of 2023.
  • NeuroPace will host a conference call to discuss the first quarter 2024 financial results after market close on Wednesday, May 8, 2024, at 4:30 P.M. Eastern Time.

FDA Grants Orphan Drug Designation to Biompharma’s Bi104, a microbiome-modifying biologic, for the treatment of Angelman Syndrome

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Mercoledì, Maggio 8, 2024
FDA, Speech, Hope, Angelman syndrome, Food, Neuroinflammation, Parkinson's disease, Neurodevelopmental disorder, Epilepsy, Research, Spectrum, Seizure, Alzheimer's disease, Disease, Therapy, Patient, DSM-IV codes, Intellectual disability, Multiple sclerosis, Pharmaceutical industry

Sarasota, Florida, May 08, 2024 (GLOBE NEWSWIRE) -- BIOM Pharmaceutical Corporation is thrilled to announce that Bi104, its innovative drug product, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Angelman syndrome (AS).

Key Points: 
  • Sarasota, Florida, May 08, 2024 (GLOBE NEWSWIRE) -- BIOM Pharmaceutical Corporation is thrilled to announce that Bi104, its innovative drug product, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Angelman syndrome (AS).
  • Angelman Syndrome (AS) is a rare neurodevelopmental disorder characterized by developmental delay, intellectual disability, speech impairment, and motor abnormalities.
  • Currently, there is no specific treatment approved for preventing or controlling AS.
  • “Procuring orphan designation for Bi104 is a major milestone for us and validates our technology and formulation to initiate a clinical program.

Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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Martedì, Maggio 7, 2024
Angioedema, FDA, Mouth, NDA, Food, Swelling, Skin, Research, Attention deficit hyperactivity disorder, Insurance, Trial of the century, ADHD, Lennox–Gastaut syndrome, Dermatology, Seizure, Prescription, Public expenditure, Riluzole, Vomiting, Patent, Patient, Adrenaline, Common stock, Anaphylaxis, Epilepsy, Diazepam, PD, Therapy, Serdexmethylphenidate/dexmethylphenidate, Type, Pharmaceutical industry

“We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Total revenues increased to $12.1 million in the first quarter 2024 from $11.1 million in the first quarter 2023.
  • Research and development expenses increased to $5.9 million in the first quarter 2024 from $3.5 million in the first quarter 2023.
  • Non-GAAP adjusted EBITDA loss was $7.2 million in the first quarter 2024, compared to non-GAAP adjusted EBITDA loss of $3.9 million in the first quarter 2023.

Marinus Pharmaceuticals Provides Business Update and Reports First Quarter 2024 Financial Results

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Mercoledì, Maggio 8, 2024
Biotechnology, Pharmaceutical, Health, Epilepsy, FDA, Lennox–Gastaut syndrome, Administration, Investment, NDA, Food, Research, Human services, New Drug Application, CDD, Security (finance), API, Development, Seizure, Data monitoring committee, GABAA, Therapy, Ganaxolone, TSC, Data, Patient, Tuberous sclerosis, Medication, File, GAAP, Pharmaceutical industry

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the first quarter ended March 31, 2024.
  • “Our unwavering commitment is to develop innovative treatment options for individuals with seizure disorders,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus.
  • Increased full year 2024 projected U.S. ZTALMY net product revenues to between $33 and $35 million from a range of $32 and $34 million.
  • Marinus will focus its resources on the continued commercialization and development of ZTALMY, including the TrustTSC trial.

Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study (VNS); Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems

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Mercoledì, Maggio 8, 2024
Medical Devices, Health, Biometrics, Health Technology, Clinical Trials, Biotechnology, Migraine, Parasympathetic nervous system, Post-traumatic stress disorder, Autonomic nervous system, Cluster headache, Stroke, Depression, Heart rate, VNS, Patient, Arousal, Conditional sentence, Epilepsy, Medical research, Nervous system, EEG, Clinical trial, Associate, Anxiety, Vagus nerve, Northwell Health

Through this collaboration, Tivic Health has confirmed the effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) approach, which induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas.

Key Points: 
  • Through this collaboration, Tivic Health has confirmed the effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) approach, which induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas.
  • Physiological measurements were taken before, during, and after ncVNS treatment to assess the impact on the autonomic nervous system, cardiac function, and brain activity.
  • The trial validated Tivic Health’s novel and proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity.
  • The vagus nerve regulates many organ systems associated with chronic disease and thus modulating activity in this nerve pathway is of significant interest in the medical industry.

Encoded Therapeutics Presents Preclinical Data Across its Gene Therapy Portfolio at the 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

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Martedì, Maggio 7, 2024
Biotechnology, Neurology, Health, Genetics, Pharmaceutical, DRG, SCN9A, Seizure, Risk, Angelman syndrome, Locomotion, UBE3A, Human, Neurodevelopmental disorder, Abstract, Code, AAV, Epilepsy, Ataxia, CNS, GABAergic, Disease, Incidence, IPSC, Spinal cord, MAPT, Intellectual disability, Central nervous system, DSM-IV codes, Neuron, NHP, Therapy, Gene, MicroRNA, Vaccine

“We are thrilled to share multiple advancements across our portfolio of precision genetic medicines, showcasing substantial progress across various fronts.

Key Points: 
  • “We are thrilled to share multiple advancements across our portfolio of precision genetic medicines, showcasing substantial progress across various fronts.
  • These data underscore our platform’s potential to deliver precision therapies for a range of CNS diseases,” said Stephanie Tagliatela, Chief Scientific Officer at Encoded.
  • Encoded’s vector engineering platform has enabled the development of GABA-selective AAV-mediated gene therapies designed to potentiate GABAergic neurotransmission and modulate the circuit dysfunction underlying refractory epilepsies.
  • These data support further development of our candidate gene therapy for the treatment for refractory epilepsies.

Komodo Health & Partners Present 33 Real-World Evidence Research Studies at ISPOR 2024

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Lunedì, Maggio 6, 2024
Technology, Health, Venture Capital, Professional Services, Artificial Intelligence, Oncology, Other Science, Mental Health, Research, Software, Health Technology, Science, COVID-19, Clinical Trials, Komodo, University of Washington, Lennox–Gastaut syndrome, FDA, Public, University, Target, International Society, RWE, Pregnancy, Policy, AI, Prevalence, Colorectal cancer, Myriad Genetics, LGS, Chronic inflammatory demyelinating polyneuropathy, Neutropenia, CRC, Conference, Workflow, REMS, Genetics, Schizophrenia, Takeda Pharmaceutical Company, Mental health, Neurology, RWD, MPH, Patient, Hypertension, Epilepsy, Gestational age, Standard of care, Stillbirth, Pharmacoeconomics, ZS, Merck, ZS Associates, Breast cancer, Mitigation, Pharmaceutical industry

Komodo Health today announced the publication of 33 new health economics and outcomes research (HEOR) studies using its Healthcare Map and AI-powered technology platform.

Key Points: 
  • Komodo Health today announced the publication of 33 new health economics and outcomes research (HEOR) studies using its Healthcare Map and AI-powered technology platform.
  • The studies, to be featured at the 2024 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Global Conference, shed light on important disease trends spanning women’s health, oncology, mental health, hypertension, neurology, and more.
  • Komodo Health researchers studied the differences in patient outcomes for pregnant women who continued or discontinued the use of antidepressants during pregnancy.
  • Komodo Health researchers analyzed whether the COVID-19 pandemic exacerbated inequities in breast cancer care through its impact on breast cancer staging and HCRU.

2024 World Brain Day Dedicated to Brain Health and Prevention

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Martedì, Maggio 7, 2024
Public, World government, Myenteric plexus, Mayo Clinic, Stroke, Parkinson's disease, WHO, Social media, Neurological disorder, World Health Organization, Policy, Risk, WBD, Guest, Health care, MD, Life, Alzheimer's disease, Culture, Exercise, Smoking cessation, Encephalitis, Society, Diet, Meningitis, DSM-IV codes, Movement, Epilepsy, Multiple sclerosis, Dementia, Sleep, WFN

LONDON, May 7, 2024 /PRNewswire/ -- The World Federation of Neurology (WFN) is pleased to announce Brain Health and Prevention as the theme for the 2024 World Brain Day (WBD 2024), taking place on Monday, July 22.

Key Points: 
  • LONDON, May 7, 2024 /PRNewswire/ -- The World Federation of Neurology (WFN) is pleased to announce Brain Health and Prevention as the theme for the 2024 World Brain Day (WBD 2024), taking place on Monday, July 22.
  • "This World Brain Day is a chance for us to unite and advocate for our present and future," says Prof. Tissa Wijeratne, World Brain Day Co-Chair.
  • "As we approach World Brain Day 2024, let's come together to support brain health and prevention.
  • Mark your calendars for July 22—a day dedicated to celebrating brain health and promoting prevention.