Rhinitis

Biotechs Zero in on New Pancreatic Therapies as Global Pancreatic Cancer Market Expected Reach to $7.4 Billion By 2032

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星期五, 五月 24, 2024
News, HER2, Investment, Pfizer, Chimera, Hallucination, Pancreas, Blood, Pancreatic cancer, Breast cancer, Anxiety, Medicine, Proteolysis, Therapy, TSX, Nucleic acid thermodynamics, Survival, TIL, PALM, ONC, TILS, Magnetic resonance imaging, ABBV, NASAR, MD, Gemcitabine, PFE, Immunotherapy, PDAC, ARVN, DSM-IV codes, Safety, FOLFIRINOX, Psychiatry, Research, Cancer, Rhinitis, ASCO, Society, Patient, Doctor of Philosophy, DNA, Prevalence, Diagnosis, Growth, Social media, Pancreatic Cancer Action Network, Abstract, Personalized medicine, ESMO, Oncolytics Biotech, Classic, Oncology, Annual general meeting, Pharmaceutical industry

With its low survival rates and limited treatment options, pancreatic cancer remains a significant focus of medical research and development efforts.

Key Points: 
  • With its low survival rates and limited treatment options, pancreatic cancer remains a significant focus of medical research and development efforts.
  • The report said: “This growth is driven by increasing instances of pancreatic cancer and higher investments in pancreatic oncology research.
  • In recent years, the pancreatic cancer market has experienced steady growth, largely driven by the increasing prevalence of pancreatic cancer cases globally.
  • BioSpace concluded: “Several notable trends are shaping the pancreatic cancer market.

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

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星期三, 四月 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.

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

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星期二, 二月 20, 2024
Allergy, Epinephrine autoinjector, SAN, EMA, PD, Caregiver, Committee, CRL, Doctor of Philosophy, RN, ARS, Absorption, FDA, Food, File, Anaphylaxis, Heart rate, NAC, PDUFA, Agency, Entrepreneurship, Complete Response Letter, FARE, Symantec Endpoint Protection, Safety, Health, Lower respiratory tract infection, University, Rhinitis, Nasal mucosa, CHMP, European Medicines Agency, Nitrosamine, Patient, Pediatrics, IM, Adrenaline, Translational research, Trial of the century, Pharmaceutical industry

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

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星期二, 三月 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

      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

      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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      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

      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

      157
      158

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

      159
      160
      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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      162

      ?

      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
      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.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

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

      292

      intracutaneous or provocation testing.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
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      EMA/CHMP/72790/2024

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      306

      7.1.

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      EMA/CHMP/72790/2024

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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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      415

      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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      455

      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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      527

      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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      561

      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      EMA/CHMP/72790/2024

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      595

      4.

    • Allergol Immunopathol, 1989;

      602

      17(2):53-65

      603

      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

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星期日, 二月 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

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星期五, 二月 16, 2024
Psyllium, Key, Inhalation, Committee, Monograph, Conjunctivitis, Inflammation, Pain, Bronchospasm, Anaphylaxis, Hemorrhoid, Human, Eye, Allergy, Date, Defecation, Risk, Seed, Mouth, Constipation, Safety, Stomach, Rectum, Plantago, Rhinitis, Patient, Medicine, Bleeding, Abdominal distension, Anal, Herbal medicine, Flatulence, Failure, Water

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

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星期五, 二月 16, 2024
Key, Inhalation, Committee, Monograph, Diet, Conjunctivitis, Inflammation, Pain, Bronchospasm, Anaphylaxis, Hemorrhoid, Human, Eye, Allergy, Date, Defecation, Risk, Seed, Mouth, Constipation, Hypercholesterolemia, Safety, Irritable bowel syndrome, Stomach, Rectum, Rhinitis, Abdominal pain, Patient, Medicine, Disease, Bleeding, Abdominal distension, Anal, Herbal medicine, Flatulence, Failure, Water

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

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星期四, 二月 15, 2024
Air pollution, AAAAI, Pollutant, Ozone, Research, Multimedia, FGL2, CLC, Female, Asthma, FEV1, Master of Philosophy, RNA, TNFRSF10C, Gene expression, Rhinitis, White, Patient, Journal, MPH, Gene, Dermatitis, Spirometry, American Academy, Pharmaceutical industry

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

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星期二, 二月 13, 2024
AAAAI, FPIES, Research, Multimedia, Eosinophilic esophagitis, Quality of life, Atopic dermatitis, Immunoglobulin E, Asthma, Drug, Communication, Annual general meeting, NYU, Rhinitis, Milk, Patient, Journal, Food, American Academy

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

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星期二, 一月 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.