Rhinitis

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024
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SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

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

Retrieved on: 
Tuesday, March 12, 2024
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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

      14
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      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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      53

      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.

    • 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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      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.

    • 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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      127

      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

      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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      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

      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

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
      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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      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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      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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      7.1.

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

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      8.2.1.

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

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      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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      10.2.

    • 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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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      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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Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024

Retrieved on: 
Sunday, February 25, 2024
Allergy, Ophthalmology, AAAAI, Omalizumab, Upper respiratory tract infection, Dermatology, Allergic rhinitis, Season, Hematology, Rhinitis, Immunology, Patient, Autoimmunity, Clinical trial, PPP, SOC, Asthma, Insurance, American Academy, Pharmaceutical industry

The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.

Key Points: 
  • The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.
  • This Phase II study shows that 100mg LP-003 significantly improved nasal symptoms (TNSS score) of uncontrolled seasonal allergic rhinitis patients despite SoC treatment.
  • We are honored to unveiled the exciting Phase II results of LP-003, the first registrational clinical trial of anti-IgE antibody for AR conducted in China."
  • As Longbio Pharma charts its course forward, the successful Phase II study of LP-003 in allergic rhinitis represents a pivotal milestone in advancing the treatment landscape for allergic diseases.

Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024
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Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024
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Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Ozone and PM2.5 Exposure is Associated with Nasal Key Driver Gene Expression in People with Asthma

Retrieved on: 
Thursday, February 15, 2024
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MILWAUKEE, Feb. 15, 2024 /PRNewswire-PRWeb/ -- Nasal key driver gene expression representing T-cell mediated immune processes is associated with ozone and fine particulate matter (PM2.5) exposure in people with asthma according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting.

Key Points: 
  • MILWAUKEE, Feb. 15, 2024 /PRNewswire-PRWeb/ -- Nasal key driver gene expression representing T-cell mediated immune processes is associated with ozone and fine particulate matter (PM2.5) exposure in people with asthma according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting.
  • In the study, researchers identified six key driver genes for ozone and three key driver genes for PM2.5 exposure.
  • FGL2, previously reported as a master regulator of asthma, was the most upstream key driver for both ozone and PM2.5.
  • The findings suggest exposure to ozone and PM2.5 in individuals with asthma is associated with nasal key driver gene expression representing T-cell mediated immune processes.

Home Reintroduction of FPIES Food Triggers May Be Safe and Effective for Children

Retrieved on: 
Tuesday, February 13, 2024
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MILWAUKEE, Feb. 13, 2024 /PRNewswire-PRWeb/ -- Home reintroduction of pediatric food protein-Induced enterocolitis syndrome (FPIES) food triggers may be safe for carefully preselected children with food allergies according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, in Washington, DC this month.

Key Points: 
  • MILWAUKEE, Feb. 13, 2024 /PRNewswire-PRWeb/ -- Home reintroduction of pediatric food protein-Induced enterocolitis syndrome (FPIES) food triggers may be safe for carefully preselected children with food allergies according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, in Washington, DC this month.
  • Continued research in this area will enable allergists to make shared decisions with patient families, identifying suitable candidates among children with FPIES for gradual home reintroduction of triggers at appropriate ages.
  • With a median age of 23.5 months, 28 patients attempted reintroduction of FPIES food triggers with 71.5% of reintroduction at home and 28.5% in a medical facility as a formal food challenge.
  • With home reintroduction considered safe for carefully preselected children, children have more treatment options and may have better outcomes and improved quality of life, the research shows.

Trident Air to preview upcoming wall-mountable interlocking air purifier at CES 2024

Retrieved on: 
Tuesday, January 9, 2024
Trident, Noise, LAS, Agency, Atmosphere of Earth, Rhinitis, PR, Sinusitis, Environment, Bacteria, Consumer Electronics Show, HEPA, Singaporeans, Noetics, Virus, OAF, CES, Atmosphere

LAS VEGAS, Jan. 9, 2024 /PRNewswire-PRWeb/ -- Today, Trident Air, a leader in innovative air purification solutions, is excited to announce its participation in the 2024 Consumer Electronics Show (CES). The brand will be exhibiting in Vegas at The Venetian Expo Hall G, Eureka Park, booth 61613 from January 9 - 12, 2024, offering an exclusive sneak peek of its upcoming HEX wall-mountable and interlocking air purifier, alongside its bestselling Hunter and Bliss models.

Key Points: 
  • HEX features the brand's proprietary Air Dome Technology, which disinfects air and surfaces in minutes
    LAS VEGAS, Jan. 9, 2024 /PRNewswire-PRWeb/ -- Today, Trident Air , a leader in innovative air purification solutions, is excited to announce its participation in the 2024 Consumer Electronics Show (CES).
  • HEX, due to launch in Q1 2024, is the slimmest and lightest of Trident Air's purifiers.
  • "Our Air Dome Technology mimics the germicidal properties of outdoor air," said Dr. Ivan Tan, Trident Air Co-founder and Principal Scientist.
  • Trident Air is excited to preview the HEX, which is still in development, at CES 2024.

Can you really be allergic to alcohol?

Retrieved on: 
Friday, January 5, 2024
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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.

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Monday, December 11, 2023
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Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.