Histamine

Altamira Therapeutics Provides Business Update

Retrieved on: 
Mardi, mai 28, 2024
Francs, Transport, AVS, Histamine, Patient, Weight gain, COVID-19, Amnesia, Swiss franc, Betahistine, Liver, Clinical trial, Messenger, Therapy, Dementia, Tourette syndrome, Orphan drug, Freezing, Research, Narcolepsy, RNA, Communication, Special, Prader–Willi syndrome, ADHD

HAMILTON, BERMUDA / May 28, 2024 / Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today provided a business update related to its RNA delivery platform, partnering of its legacy assets, corporate structuring and financial reporting.

Key Points: 
  • HAMILTON, BERMUDA / May 28, 2024 / Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today provided a business update related to its RNA delivery platform, partnering of its legacy assets, corporate structuring and financial reporting.
  • Further, the Company is about to merge two of its subsidiaries in Basel (Switzerland), Auris Medical AG and Altamira Therapeutics AG.
  • Following completion of the merger, the Altamira Group will comprise the parent company Altamira Therapeutics Ltd. (Hamilton, Bermuda), and its subsidiaries Altamira Therapeutics AG (Basel, Switzerland), Altamira Therapeutics Inc. (Newark DE, USA), Otolanum AG (Basel, Switzerland) as well as the associated company Altamira Medica AG (Basel, Switzerland).
  • Altamira plans to release its half-year 2024 financial results and business update report by the end of August 2024.

Alto Neuroscience Reports First Quarter 2024 Financial Results and Recent Business Highlights

Retrieved on: 
Mardi, mai 14, 2024
Mental Health, Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, CIAS, PET, Partnership, Patient, PDE4, Human, EEG, MDD, Central nervous system disease, Depression, Overalls, Safety, NMDA, Dopamine, Neuroscience, CNS, DSM-IV codes, Brain, Society, Psychopharmacology, Research, Schizophrenia, Anhedonia, Cognition, Histamine, Pharmaceutical industry

Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the first quarter ended March 31, 2024, and highlighted recent corporate progress.

Key Points: 
  • Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the first quarter ended March 31, 2024, and highlighted recent corporate progress.
  • Alto is currently evaluating ALTO-100 in a 266-patient Phase 2b study in MDD patients characterized by a memory-based cognitive biomarker.
  • Enrollment is ongoing and the Company expects to report topline data in the second half of 2024.
  • Net Loss: The Company incurred a net loss of $13.4 million for the quarter ended March 31, 2024, as compared to $7.3 million for the quarter ended March 31, 2023.

Altamira Therapeutics Provides Business Update, Reports Full Year 2023 Financial Results

Retrieved on: 
Mercredi, avril 10, 2024
FDA, Drug discovery, Synovitis, Cell, Research, Vaccine, IND, Nanoparticle, Allergic rhinitis, DNMT3B, Dicarboxylic acid, Inflammation, Hearing loss, Osteoarthritis, Vertigo, RNA, Myocardial infarction, Patent, CHF, Messenger, Betahistine, Therapy, Semaphore, AVS, Dizziness, AAV, Tinnitus, Heqet, Rhinitis, Central nervous system, Clinical trial, Small RNA, Sale, Cancer, EDT, Liver, Patient, Rheumatoid arthritis, Histamine, Regeneration

HAMILTON, BERMUDA -- April 10, 2024 -- Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today provided a business update and reported its full year 2023 financial results.

Key Points: 
  • "Altamira emerged from the 2023 business year as a stronger and more focused company," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman, and CEO.
  • "We keep progressing with our RNA delivery business, concluding recently our second collaboration agreement with another exciting biotech company.
  • Altamira expects to make further progress in 2024 with the strategic repositioning by partnering its inner ear therapeutics assets.
  • Altamira’s Senior Management will hold an investor call today, Wednesday, April 10, 2024, at 8:30 a.m. EDT to discuss its business update and full-year 2023 results.

HARMONY BIOSCIENCES ANNOUNCES EXCLUSIVE AGREEMENT TO DEVELOP AND COMMERCIALIZE TPM-1116, A HIGHLY POTENT AND SELECTIVE ORAL OREXIN-2 RECEPTOR AGONIST

Retrieved on: 
Jeudi, avril 11, 2024
Hypothalamus, Sleep disorder, Research, Narcolepsy, Patient, Histamine, Harmony, OX2R, Pharmaceutical industry

PLYMOUTH MEETING, Pa., April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.

Key Points: 
  • PLYMOUTH MEETING, Pa., April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.
  • Narcolepsy and other hypersomnolence disorders continue to be a large market opportunity with significant unmet medical need.
  • Under the agreement, Harmony will pay Bioprojet an upfront license fee of $25.5 million for the exclusive right to develop, manufacture and commercialize TPM-1116 in the U.S. and Latin American territories.
  • Finally, Harmony will pay a royalty rate in the mid-teens on sales of product in the licensed territories.

Alto Neuroscience Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Jeudi, mars 21, 2024
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Modafinil, Research, Depression, EEG, DSM-IV codes, Histamine, Brain, Regenerative medicine, CFO, NMDA, MDD, Partnership, Patient, CNS, CIAS, Neuroscience, CIRM, Anhedonia, IPO, PDE4, Overalls, IND, Biogen, Cognition, Johnson & Johnson, Central nervous system disease, Pharmaceutical industry

Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the full year ended December 31, 2023, and highlighted recent corporate progress.

Key Points: 
  • Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the full year ended December 31, 2023, and highlighted recent corporate progress.
  • In January 2023, Alto reported positive results from a Phase 2a study in which patients with MDD and a cognitive biomarker signature were identified as more responsive to ALTO-100.
  • Alto is currently evaluating ALTO-100 in a 266-patient Phase 2b study in MDD patients characterized by the cognitive biomarker.
  • The increase was primarily attributable to costs associated with the Phase 2a clinical studies for ALTO-100 and ALTO-300, which were completed in 2023.

Parental avoidance of toxic exposures could help prevent autism, ADHD in children, new study shows

Retrieved on: 
Jeudi, mars 28, 2024
Pesticide, Sensitivity, Xenobiotic, Collaborative writing, Prevalence, ADHD, Cell, Risk, Inflammation, Patient, SAN, School, Anglo-French Wars, Tissue, Research, Miller, Child, Breast, Virus, University, Wane, Doctor of Philosophy, Pregnancy, Causality, Attention deficit hyperactivity disorder, Gulf War, B cell, EPA, CDC, University of Texas System, Fire, Toxicology, Workforce, Public health, TILT, Spectrum, Family, Histamine, Vaccine

SAN ANTONIO, March 27, 2024 /PRNewswire-PRWeb/ -- Autism and attention deficit hyperactivity disorder (ADHD) may be preventable if parents avoid toxic exposures and adopt interventions such as environmental house calls, according to a published study led by researchers from The University of Texas Health Science Center at San Antonio (UT Health San Antonio).

Key Points: 
  • The findings build on a 2015 study by UT Health San Antonio that first linked chemical intolerance in patients with the risk of their children developing autism and ADHD.
  • "Up to now, most interventions have been behavioral or medical, after a child is diagnosed."
  • Still, they wrote, "The implications of this study, if confirmed, could be significant for preventive measures and early intervention strategies in families with parental chemical intolerance.
  • And the prevalence of ADHD has risen to one in eight children, also according to the CDC.

ARS Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study

Retrieved on: 
Lundi, février 26, 2024
SAN, Incidence, The Study, AAAAI, Caregiver, Angioedema, Histamine, Principal, ARS, FDA, Quality of life, Anaphylaxis, Body surface area, Data, Convention center, Skin, Safety, Joint task force, Allergy, Patient, Flare, Data analysis, CSU, Erythema, Pediatrics, Asthma, Adrenaline, Itch, American Academy, Pharmaceutical industry

Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

Key Points: 
  • Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
  • “Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis.
  • neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients.
  • This would follow the anticipated FDA approval of neffy for allergic reactions (Type I) including anaphylaxis in the second half of 2024.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Mardi, mars 12, 2024
Filtration, Vespula, Toxicity, Histamine, EAACI, Immunotherapy, Asthma, Report, Allergy, Skin, Pregnancy, PR, EEC, MITES, RNA, Criterion, History, CMR, Contraindication, HEP, Draft, Guideline, Patient, Ames test, Diagnosis, Dermatitis, Venom, Literature, Trial of the century, Reproduction, Silicon–germanium, SPT, Food allergy, Cosmetics, EECS, Absorption, Marketing, Safety, Data collection, Directive 2001/83/EC, GMP, ID50, Antibody, Documentation, European, Type IV hypersensitivity, Genotoxicity, Applicant (sketch), Aeroallergen, CHMP, PRIME, Immunoglobulin G, Type, Publication, Biology, Pollen, DNA, Environment, Immune system, Toolbox, NLN, AIT, Atopic dermatitis, Fatality, Chapter, Anaphylaxis, Process validation, ICH, Antigen, Rhinitis, Clinical trial, Erythema, Knowledge, Prescription, Human, Network, Medication, Scope, VIT, ICT, EMA, Collection, Macrophage, Outline, Metabolism, Registry, Inflammation, Immunoglobulin E, Nature, European Pharmacopoeia, Food, Risk, Prevalence, Mastocytosis, Observation, Cytokine, NPP, Patient safety, Disease, Finished, Medical device

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Key Points: 
    • 16

      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

      18

      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

      66

      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

      72

      considerations for allergen products within the scope of the guideline.

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      EMA/CHMP/72790/2024

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

      128

      conditions will require separate clinical trials (see Section 6).

    • 129

      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      158

      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      161

      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

      199

      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      EMA/CHMP/72790/2024

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      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

      292

      intracutaneous or provocation testing.

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      7.1.

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      in moderate to low-sized study populations
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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

      378

      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

      376

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      EMA/CHMP/72790/2024

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      455

      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      EMA/CHMP/72790/2024

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      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      595

      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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Press Release: Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

Retrieved on: 
Vendredi, février 16, 2024
Ministry, Histamine, Sinusitis, Omalizumab, Quality of life, Atopic dermatitis, Prurigo nodularis, MHLW, Asthma, Cell, Safety, Patient, CSU, Disease, Polyp (medicine), Pharmaceutical industry

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Can you really be allergic to alcohol?

Retrieved on: 
Vendredi, janvier 5, 2024
Awareness, Allergen, Anaphylaxis, Sodium benzoate, Risk, Immune system, Restaurant, Yeast, Allergy, Congener, Hand, Rash, Blood, Rhinitis, Histamine, Beer, Sulfite, Headache, Plant, Asthma, Wheeze, Flushing, Tartrazine, Enzyme

Some people get allergy-like symptoms when drinking alcohol, but can you really be allergic to alcohol?

Key Points: 
  • Some people get allergy-like symptoms when drinking alcohol, but can you really be allergic to alcohol?
  • The reason is that alcohol dilates blood vessels, which then sets the stage for a symphony of bodily responses.
  • Unlike allergies, which involve the immune system, intolerances arise when the body lacks the necessary enzymes to digest and eliminate alcohol.
  • True allergic reactions stemming from yeasts are a rare occurrence, dampening the suspicion that this microscopic organism is the chief cause.