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

Retrieved on:

Thursday, March 21, 2024

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:

Thursday, March 28, 2024

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:

Monday, February 26, 2024

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:

Tuesday, March 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:

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

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Table of contents

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

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1.
Specific effects ................................................................................................. 17
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Guideline on allergen products development for immunotherapy and allergy diagnosis
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12.
Management for allergies may involve avoidance of the allergen, medications to relieve
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symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.
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Recommendations are made on the clinical development, potential study designs and safety

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considerations for allergen products within the scope of the guideline.
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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.
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Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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quality and clinical development according to the current knowledge.
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However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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conditions will require separate clinical trials (see Section 6).
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In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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

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substantially to the allergen products as discussed above.
1
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Guideline on the clinical development of products for specific immunotherapy for the treatment

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of allergic diseases - CHMP/EWP/18504/2006
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Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

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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

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?

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

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4.
In any
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case, a reduced validation should include all relevant manufacturing process steps that are considered
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product specific.
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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,

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intracutaneous or provocation testing.
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7.1.
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8.
Clinical development of products for AIT: Study design,
efficacy and safety
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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
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dose finding for the therapeutic allergen could be investigated.
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8.2.1.
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In general, sensitivity and specificity of the product should be determined.
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10.2.
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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:

Friday, February 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:

Friday, January 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.

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Retrieved on:

Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Key Points:

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

AB Science: The clinical development of masitinib in sickle cell disease is among the 19 winning projects under the sixth call for “Hospital-Inuversity Research in health (RHU)”

Retrieved on:

Monday, November 27, 2023

THE CLINICAL DEVELOPMENT OF MASITINIB IN SICKLE CELL DISEASE, A HIGHLY PREVALENT GENETIC CONDITION, IS AMONG THE 19 WINNING PROJECTS UNDER THE SIXTH CALL FOR "HOSPITAL-UNIVERSITY RESEARCH IN HEALTH (RHU)".

Key Points:

THE CLINICAL DEVELOPMENT OF MASITINIB IN SICKLE CELL DISEASE, A HIGHLY PREVALENT GENETIC CONDITION, IS AMONG THE 19 WINNING PROJECTS UNDER THE SIXTH CALL FOR "HOSPITAL-UNIVERSITY RESEARCH IN HEALTH (RHU)".
A new patent has been filed, which, if granted, will extend the international protection of masitinib in sickle cell disease until 2040.
Current treatment options such as hydroxycarbamide, chronic transfusion or anti-P-selectin antibodies, do not fully prevent life-threatening acute and chronic complications of sickle cell disease.
There is a significant medical need to prevent the acute and chronic complications of sickle cell disease.

PharmAbcine Publishes Study in Science Advances Demonstrating the Potential of PMC-403 in Preclinical Models of Idiopathic Systemic Capillary Leak Syndrome

Retrieved on:

Thursday, November 23, 2023

Study reveals a promising avenue for addressing Idiopathic Systemic Capillary Leak Syndrome (ISCLS, a.k.a.

Key Points:

Study reveals a promising avenue for addressing Idiopathic Systemic Capillary Leak Syndrome (ISCLS, a.k.a.
The results underscore the novel mechanism of action, demonstrating the ability of PMC-403 to reduce vascular leakage associated with ISCLS in the preclinical models.
In February 2023, the US FDA granted Orphan Drug Designation (ODD) for PMC-403 for the treatment of Systemic Capillary Leak Syndrome.
Dr. Kirk Druey's team shared enthusiasm for the potential breakthrough, underscoring their strong determination to advance into clinical trial.

Myotonic Dystrophy Drug Pipeline Research Report 2023: Comprehensive Insights About 20+ Companies and 22+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on:

Thursday, September 14, 2023

The "Myotonic Dystrophy - Pipeline Insight, 2023" report offers an extensive overview of the Myotonic Dystrophy pipeline landscape, featuring insights on over 20 companies and 22 pipeline drugs.

Key Points:

The "Myotonic Dystrophy - Pipeline Insight, 2023" report offers an extensive overview of the Myotonic Dystrophy pipeline landscape, featuring insights on over 20 companies and 22 pipeline drugs.
For a holistic understanding, it includes a detailed disease overview and Myotonic Dystrophy treatment guidelines.
Currently, the drug is being investigated in the Phase II/III stage of clinical trial evaluation for the treatment of Congenital Myotonic Dystrophy.
This segment of the report provides insights about the different Myotonic Dystrophy drugs segregated based on following parameters that define the scope of the report, such as:
There are approx.