Omalizumab

Latitude Food Allergy Care Announces the Opening of its New San Francisco Clinic; Pacific Heights Clinic is the First-of-its-Kind and Only Clinic in San Francisco Specifically Dedicated to Food Allergy Patients

Retrieved on: 
Wednesday, March 6, 2024
Private practice, Caregiver, Research, Food allergy, Suite, MD, Van Ness Avenue, Omalizumab, Hospital, Parent, Stanford University, Virginia Mason Medical Center, Phoenix Children's Hospital, House, Internal medicine, Immunology, OIT, Clinical, Patient, Duke University, Clinical trial, Pediatrics, Food, Allergy, Shoe, Nursing

As the only clinic in San Francisco dedicated to food allergies, the new space allows Latitude to expand its hours to provide care for more families.

Key Points: 
  • As the only clinic in San Francisco dedicated to food allergies, the new space allows Latitude to expand its hours to provide care for more families.
  • As with all of Latitude's clinics, the newly built clinic is designed specifically for the needs of food allergy patients and their caregivers.
  • The bright, family room-like setting allows patients to connect with other food allergy families that are going through similar experiences.
  • “We are delighted to welcome two exceptional doctors to the Latitude Food Allergy Care family to expand access to life-changing food allergy care in the San Francisco Bay Area,” said Dr. Rani Maskatia, Medical Director of Latitude Food Allergy Care.

Jasper Therapeutics Reports Fiscal 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, March 4, 2024
AAAAI, Research, Syndrome, Omalizumab, Anaphylaxis, Option, Risk, Allergy, Annual general meeting, Therapy, Patient, Employment, CD117, CSU, Pharmaceutical industry

“2023 was a highly productive year for Jasper, as we shifted our operational focus toward briquilimab development in mast cell driven diseases,” said Ronald Martell, President and Chief Executive Officer.

Key Points: 
  • “2023 was a highly productive year for Jasper, as we shifted our operational focus toward briquilimab development in mast cell driven diseases,” said Ronald Martell, President and Chief Executive Officer.
  • Obtained regulatory clearance in the US and EU for initiation of its Phase 1b/2a BEACON study of subcutaneous briquilimab in CSU.
  • Jasper expects to report initial data from at least the first four cohorts of the study in the third quarter of 2024.
  • Jasper expects to conduct the study across four clinical sites in the EU and has activated three sites to date.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

Retrieved on: 
Saturday, February 24, 2024
AAAAI, KIT, Omalizumab, Annual general meeting, Therapy, L18, Patient, CSU, Survival, Disease, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. The studies will continue dosing patients until week 52. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who are not adequately controlled by omalizumab. The data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, in a late breaking oral presentation (L18) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024.

Key Points: 
  • HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease.
  • Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.
  • CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes.
  • Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024
BTK, QPM, BID, AAAAI, Week, Omalizumab, TID, News, Prurigo nodularis, Asthma, Swelling, IgG4-related disease, Skin, Oral medicine, UAS7, Patient, CSU, Disease, Itch, LSM, ITT, American Academy, Pharmaceutical industry

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

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.

Groundbreaking Food Allergy Treatment Research to Be Unveiled at 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Monday, February 19, 2024
Combination therapy, Food allergy, MD, Omalizumab, FDA, Anaphylaxis, Access, Risk, Allergy

MILWAUKEE, Feb. 19, 2024 /PRNewswire-PRWeb/ -- Renowned allergist Dr. Robert A. Wood, MD FAAAAI, will present detailed findings from a Phase 3 clinical trial that will have significant impact in the world of food allergy on Sunday, February 25 during a late breaking symposium during the 2024 AAAAI Annual Meeting, in Washington, DC.

Key Points: 
  • Wood, MD FAAAAI, will present detailed findings from a Phase 3 clinical trial that will have significant impact in the world of food allergy on Sunday, February 25 during a late breaking symposium during the 2024 AAAAI Annual Meeting, in Washington, DC.
  • Following the presentation, members of the media will have an exclusive opportunity to engage in a question-and-answer session with Dr. Wood and key stakeholders involved in the study.
  • The late breaking symposium and subsequent media opportunity are open exclusively to registered members of the media.
  • For on-site registration, please proceed to the Press Room, located in the convention center, level 1, room 102A.

FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

Retrieved on: 
Friday, February 16, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Infection, Allergy, Bangladesh Technical Education Board, AAAAI, Johns Hopkins Children's Center, Emergency, Hazelnut, NIAID, American Academy, Omalizumab, NIH, Friends, Food, Immunoglobulin E, News, Asthma, Anaphylaxis, FARE, Annual general meeting, Prevalence, Roche, Milk, ROG, AAFA, Patient, Family, Phase, Ageing, Education

People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).

Key Points: 
  • People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).
  • Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens.
  • Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
  • About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies, based on estimates for 2024.

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

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

TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 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-1 (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.

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.