FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. (Source: Roche Investor Update)
Source: Roche Investor Update - December 11, 2019 Category: Pharmaceuticals Source Type: news

Omalizumab Reduces Atopic Dermatitis Severity, Improves QOL in Kids Omalizumab Reduces Atopic Dermatitis Severity, Improves QOL in Kids
Omalizumab reduces the severity of atopic dermatitis (AD) in children, though it's not clear the improvement is clinically significant, according to a new randomized controlled trial.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 28, 2019 Category: Allergy & Immunology Tags: Dermatology News Source Type: news

omalizumab (Xolair)
Title: omalizumab (Xolair)Category: MedicationsCreated: 5/27/2004 12:00:00 AMLast Editorial Review: 11/15/2019 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - November 15, 2019 Category: Respiratory Medicine Source Type: news

Ligelizumab May Improve Response in Chronic Urticaria Ligelizumab May Improve Response in Chronic Urticaria
Early trial results suggest the investigational humanized anti-IgE monoclonal antibody ligelizumab binds to IgE with greater affinity than FDA-approved omalizumab for refractory chronic spontaneous urticaria.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - October 3, 2019 Category: Allergy & Immunology Tags: Allergy & Clinical Immunology News Source Type: news

Add-on omalizumab cost effective in uncontrolled allergic asthma
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - October 1, 2019 Category: Drugs & Pharmacology Source Type: news

Omalizumab: A Potential Therapy Option for Allergic Bronchopulmonary Aspergillosis (ABPA) in Asthma Patients
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - September 6, 2019 Category: Respiratory Medicine Authors: MeganB Source Type: news

Clinical trial to evaluate experimental treatment in people allergic to multiple foods
NIH and partners to assess whether Omalizumab can reduce allergic reactions. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - August 1, 2019 Category: American Health Source Type: news

Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies
Roche today announced positive topline data from two Phase III multicenter studies evaluating Xolair ® (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids. (Source: Roche Investor Update)
Source: Roche Investor Update - June 3, 2019 Category: Pharmaceuticals Source Type: news

Economics of omalizumab responder identification in asthma
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - May 1, 2019 Category: Drugs & Pharmacology Source Type: news

In Chronic Urticaria, Staying on Treatment Matters
(MedPage Today) -- 55% of patients who stopped taking omalizumab saw return of symptoms (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - February 27, 2019 Category: Primary Care Source Type: news

Omalizumab add-on therapy cost effective in severe asthma in Spain
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2019 Category: Drugs & Pharmacology Source Type: news

Novartis receives European Commission approval for self-administration of Xolair ® across all indications
Novartis today announced that the European Commission (EC) has approved Xolair® (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment. With this approval, Xolair is the first and only biologic to offer the option of self-administration for SAA and CSU. (Source: World Pharma News)
Source: World Pharma News - December 13, 2018 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

Novartis's New Treatment for Hives Outperforms Xolair in Trials Novartis's New Treatment for Hives Outperforms Xolair in Trials
Novartis said on Tuesday it was taking its experimental medicine ligelizumab to late-stage trials after the drug showed signs of outperforming existing product Xolair in treating severe urticaria.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - December 7, 2018 Category: Allergy & Immunology Tags: Dermatology News Source Type: news

Novartis's new treatment for hives outperforms Xolair in trials
Novartis said on Tuesday it was taking its experimental medicine ligelizumab to late-stage trials after the drug showed signs of outperforming existing product Xolair in treating severe urticaria, also known as hives. (Source: Reuters: Health)
Source: Reuters: Health - December 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis goes after Roche asthma medicine Xolair with new drug
Novartis said it is pushing ahead with a late-stage study of its experimental drug ligelizumab after announcing the medicine outperformed Roche's Xolair in a Phase II clinical trial against urticaria, also known as hives. (Source: Reuters: Health)
Source: Reuters: Health - December 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Omalizumab Seems Safe, Effective for Real-World Chronic Idiopathic Urticaria Omalizumab Seems Safe, Effective for Real-World Chronic Idiopathic Urticaria
In real-world patients with chronic idiopathic urticaria (CIU), omalizumab meets or exceeds the safety and efficacy results seen in clinical trials, researchers say.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 27, 2018 Category: Allergy & Immunology Tags: Dermatology News Source Type: news

Omalizumab Effective Rescue Therapy for Status Asthmaticus Omalizumab Effective Rescue Therapy for Status Asthmaticus
Omalizumab can be effective as rescue therapy for refractory status asthmaticus related to pollen allergy, a case report suggests.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 21, 2018 Category: Allergy & Immunology Tags: Pulmonary Medicine News Source Type: news

Omalizumab Treatment in Patients with Cystic Fibrosis (CF) and Allergic Bronchopulmonary Aspergillosis (ABPA): a Case Series
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - November 16, 2018 Category: Respiratory Medicine Authors: GAtherton Source Type: news

Cost-Effectiveness of Omalizumab for Chronic Urticaria Cost-Effectiveness of Omalizumab for Chronic Urticaria
How cost-effective is omalizumab compared with standard of care with antihistamines?The British Journal of Dermatology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 5, 2018 Category: Consumer Health News Tags: Dermatology Journal Article Source Type: news

FDA grants approval of Xolair (omalizumab) prefilled syringe formulation
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair ® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. (Source: Roche Investor Update)
Source: Roche Investor Update - October 1, 2018 Category: Pharmaceuticals Source Type: news

FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
South San Francisco, CA -- September 28, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

10 Year evaluation of patients with severe uncontrolled allergic asthma treated with Omalizumab.
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - September 27, 2018 Category: Respiratory Medicine Authors: GAtherton Source Type: news

Real-life experience of Omalizumab in adult Cystic Fibrosis patients with allergic severe asthma and Allergic Bronchopulmonary Aspergillosis
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - September 27, 2018 Category: Respiratory Medicine Authors: GAtherton Source Type: news

Morning Break: DNA Risk Calculator; Xolair for Food Allergies; Med Students Ditch School
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - August 14, 2018 Category: Psychiatry Source Type: news

FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies
Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair ® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. (Source: Roche Investor Update)
Source: Roche Investor Update - August 13, 2018 Category: Pharmaceuticals Source Type: news

Study suggests similarity between biosimilar GBR 310 and omalizumab: Glenmark
Glenmark Pharma said that results from a study suggests similarity between biosimilar GBR 310 and the reference product omalizumab. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 26, 2018 Category: Pharmaceuticals Source Type: news

Impact of Omalizumab Treatment in Severe Allergic Asthma Impact of Omalizumab Treatment in Severe Allergic Asthma
A new study provides a clinical and cost analysis regarding the use of omalizumab in the treatment of severe asthma.BMC Pulmonary Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 16, 2018 Category: Consumer Health News Tags: Pulmonary Medicine Journal Article Source Type: news

Novartis' Xolair ® recommended in new global chronic urticaria guideline
A new global guideline on chronic urticaria (CU) recommends Xolair® (omalizumab), indicated as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines[1],[2]. Xolair is the only licensed treatment option for CSU, a type of CU, for patients unresponsive to antihistamines[1]. (Source: World Pharma News)
Source: World Pharma News - March 6, 2018 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

Longer Omalizumab Use Eases Itch From Chronic Hives Longer Omalizumab Use Eases Itch From Chronic Hives
The quality of life of patients with idiopathic urticaria improved when they stayed on the monoclonal antibody for 48 instead of 24 weeks, the XTEND-CIU study shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 5, 2018 Category: Consumer Health News Tags: Allergy & Clinical Immunology News Source Type: news

Omalizumab cost effective for chronic spontaneous urticaria
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
[9-26-2014] A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these potential risks to the drug label. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Tiotropium cost  effective alternative to omalizumab
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2018 Category: Drugs & Pharmacology Source Type: news

HealthWatch: New Treatment To Help Kids With Multiple Food Allergies
BOSTON (CBS) – Doctors may soon have a new option to treat kids with multiple food allergies. Researchers at Stanford University studied 48 children between the ages of 4 and 15 who have allergies to more than one food. They found that more than 80% of those treated with a combination of an asthma drug, Xolair, and an oral medication which helps block the body’s immune response, were able to eat at least two grams of two or more foods to which they were allergic. The allergies included milk, eggs, wheat, soy, peanuts and tree nuts. About 30% percent of people with food allergies are allergic to more than on...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - December 13, 2017 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health Local News Syndicated Local Dr. Mallika Marshall Food Allergies Source Type: news

Omalizumab improves efficacy of oral immunotherapy for multiple food allergies
Combination allows more than 80 percent of children to safely consume at least two foods to which they were allergic. (Source: National Institutes of Health (NIH) News Releases)
Source: National Institutes of Health (NIH) News Releases - December 12, 2017 Category: American Health Source Type: news

Omalizumab May Help Desensitization for Food Allergies Omalizumab May Help Desensitization for Food Allergies
A pilot study suggests omalizumab may improve speed, effectiveness, and safety of oral desensitization in children with multiple food allergies; more research is needed to see if effect lasts.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 12, 2017 Category: Consumer Health News Tags: Allergy & Clinical Immunology News Source Type: news

Omalizumab improves efficacy of oral immunotherapy for multiple food allergies
(NIH/National Institute of Allergy and Infectious Diseases) Combining a 16-week initial course of the medication omalizumab with oral immunotherapy (OIT) greatly improves the efficacy of OIT for children with allergies to multiple foods, new clinical trial findings show. After 36 weeks, more than 80 percent of children who received omalizumab and OIT could safely consume two-gram portions of at least two foods to which they were allergic, compared with only a third of children who received placebo and OIT. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 11, 2017 Category: International Medicine & Public Health Source Type: news

Intranasal Omalizumab Does Not Increase Serum IgE Levels
No relevant change in allergen - specific/total IgE levels for subjects challenged with omalizumab (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - November 22, 2017 Category: Respiratory Medicine Tags: ENT, Pharmacy, Pulmonology, Allergy, Journal, Source Type: news

Omalizumab Benefits Patients With Chronic Inducible Urticaria Omalizumab Benefits Patients With Chronic Inducible Urticaria
The recombinant anti-immunoglobulin E (IgE) monoclonal antibody omalizumab has'substantial benefits'in treating various forms of chronic inducible urticaria (CIndU), according to a new systematic review.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - August 11, 2017 Category: Allergy & Immunology Tags: Allergy & Clinical Immunology News Source Type: news

Omalizumab Response Varies by Asthma Type Omalizumab Response Varies by Asthma Type
Patients with specific phenotypes of severe asthma derive greater benefit from the biologic treatment than others, a multicenter, retrospective study shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 27, 2017 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

Omalizumab Protects Against Early, Late Allergic Responses
Significant reduction in early allergic reaction after 4 weeks, with decrease in FEV1, exhaled nitric oxide (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - June 9, 2017 Category: Respiratory Medicine Tags: Pharmacy, Pulmonology, Allergy, Journal, Source Type: news

Anti-IgE Drug Might Change Asthma Course (CME/CE)
(MedPage Today) -- Lung improvement observed in children treated with omalizumab (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - May 24, 2017 Category: Allergy & Immunology Source Type: news

omalizumab, Xolair
Title: omalizumab, XolairCategory: MedicationsCreated: 5/27/2004 12:00:00 AMLast Editorial Review: 5/15/2017 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - May 15, 2017 Category: Respiratory Medicine Source Type: news

FDA okays Glenmark's first-in-human study for respiratory drug
According to IMS sales data for the 12-month period ending February 2017, annual sales of XOLAIR 150 mg injection was approximately $1.7 billion in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 25, 2017 Category: Pharmaceuticals Source Type: news

Xolair Tx Tied to Less Hospital Time in Young Asthmatic Kids
(MedPage Today) -- Omalizumab cut incidence of unscheduled healthcare visits for ages 6-12 years (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - November 13, 2016 Category: Allergy & Immunology Source Type: news

Xolair Offers Improvements in Patients with Asthma-COPD (CME/CE)
(MedPage Today) -- Better asthma control and QoL scores, but no lung function improvement (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - November 8, 2016 Category: Primary Care Source Type: news

Omalizumab Offers Improvements in Patients with Asthma-COPD (CME/CE)
(MedPage Today) -- Better asthma control and QoL scores, but no lung function improvement (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - November 8, 2016 Category: Allergy & Immunology Source Type: news

Drop-Out Rate in Omalizumab Treatment for Severe Asthma Drop-Out Rate in Omalizumab Treatment for Severe Asthma
Find out more about the omalizumab drop-out rate among patients with severe asthma. What are the common reasons for poor treatment adherence?BMC Pulmonary Medicine (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - October 6, 2016 Category: Allergy & Immunology Tags: Pulmonary Medicine Journal Article Source Type: news

Xolair (Omalizumab) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 18, 2016 Category: Drugs & Pharmacology Source Type: news

FDA Expands Xolair to Younger Kids With Allergic AsthmaFDA Expands Xolair to Younger Kids With Allergic Asthma
Omalizumab is now indicated in children as young as age 6 years with uncontrolled moderate to severe persistent allergic asthma. FDA Approvals (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - July 11, 2016 Category: Allergy & Immunology Tags: Allergy & Clinical Immunology News Alert Source Type: news

Genentech's Xolair receives US FDA approval for allergic asthma treatment
Roche Group member Genentech has received the Food and Drug Administration (FDA) approval for Xolair (omalizumab) to treat children with moderate to severe persistent allergic asthma. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 11, 2016 Category: Pharmaceuticals Source Type: news