FDA expands use of asthma drug Xolair to treat severe food allergies
A medication used to treat asthma can now be used to help people with food allergies avoid severe reactions (Source: ABC News: Health)
Source: ABC News: Health - February 16, 2024 Category: Consumer Health News Tags: Health Source Type: news
FDA approves Xolair as first and only medicine for children and adults with one or more food allergies
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placeboMore than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2 Detailed OUtMATCH results will be featured in a late-breaking symposiumat the 2024 AAAAI Annual MeetingBasel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food ...
Source: Roche Investor Update - February 16, 2024 Category: Pharmaceuticals Source Type: news
FDA approves Xolair as first and only medicine for children and adults with one or more food allergies
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placeboMore than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2 Detailed OUtMATCH results will be featured in a late-breaking symposiumat the 2024 AAAAI Annual MeetingBasel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food ...
Source: Roche Media News - February 16, 2024 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
Group salesgrow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidanceExcluding COVID-19 products,Group sales increase by 8%Pharmaceuticals Divisionsalesincrease by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)Diagnostics Division salesare 13% lower due to high demand for COVID-19 tests in 2022; strong ...
Source: Roche Media News - February 1, 2024 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
Group salesgrow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidanceExcluding COVID-19 products,Group sales increase by 8%Pharmaceuticals Divisionsalesincrease by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)Diagnostics Division salesare 13% lower due to high demand for COVID-19 tests in 2022; strong ...
Source: Roche Investor Update - February 1, 2024 Category: Pharmaceuticals Source Type: news
Injected Xolair Therapy Could Prevent Food Allergies in Kids
THURSDAY, Dec. 21, 2023 -- A new treatment appears to reduce food allergies in children and teens, according to interim clinical trial results.
A lab-made monoclonal antibody called omalizumab (Xolair) significantly increased the amounts of common... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 21, 2023 Category: General Medicine Source Type: news
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposureInterim analysis results from first-of-its-kind phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2,3Basel, 19 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration ...
Source: Roche Media News - December 19, 2023 Category: Pharmaceuticals Source Type: news
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposureInterim analysis results from first-of-its-kind phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2,3Basel, 19 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration ...
Source: Roche Investor Update - December 19, 2023 Category: Pharmaceuticals Source Type: news
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy. (Source: World Pharma News)
Source: World Pharma News - December 19, 2023 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news
Combined Rituximab + Omalizumab Promising for Refractory BP Combined Rituximab + Omalizumab Promising for Refractory BP
Bullous pemphigoid has high morbidity and mortality, especially in people with comorbidities common to older adults, yet no Food and Drug Administration –approved therapies for BP exist.MDedge News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 8, 2023 Category: Cancer & Oncology Tags: Dermatology Source Type: news
Woman's health 'sliding backwards' after drug coverage pulled
For Janice Namiesniowski, living with asthma was like breathing "through a straw." An expensive drug called Xolair was starting to work wonders, but her coverage was suddenly cut off when Canada Life took over the Public Service Health Care Plan in July. (Source: CBC | Health)
Source: CBC | Health - October 26, 2023 Category: Consumer Health News Tags: News/Canada/Ottawa Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLunsumio (follicular lymp...
Source: Roche Investor Update - February 2, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Basel, 2 February 2023Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLun...
Source: Roche Media News - February 2, 2023 Category: Pharmaceuticals Source Type: news
Real-World Effectiveness of Omalizumab for Severe Asthma Real-World Effectiveness of Omalizumab for Severe Asthma
Findings from a real-world study support the benefits of omalizumab as a treatment option for both pediatric and adult patients with severe allergic asthma.BMC Pulmonary Medicine (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - December 30, 2022 Category: Allergy & Immunology Tags: Pulmonary Medicine Journal Article Source Type: news
Highlights in Asthma Therapy From CHEST 2022 Highlights in Asthma Therapy From CHEST 2022
From CHEST 2022, Dr Navitha Ramesh reports key data on biologic therapies for asthma patients, including results from the CLEAR study and trials on omalizumab, benralizumab, and tezepelumab.Medscape (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 9, 2022 Category: Allergy & Immunology Tags: Pulmonary Medicine ReCAP Source Type: news
