FDA approves first treatment for patients with rare type of lung disease
The U.S. Food and Drug Administration has approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. (Source: World Pharma News)
Source: World Pharma News - September 9, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
FDA Approves Ofev (nintedanib) for Interstitial Lung Disease Associated with Systemic Sclerosis or Scleroderma (SSc-ILD)
September 06, 2019 -- The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 6, 2019 Category: Drugs & Pharmacology Source Type: news
FDA Panel Recommends Nintedanib for Rare Lung Disease FDA Panel Recommends Nintedanib for Rare Lung Disease
Small effect size for primary endpoint in systemic sclerosis-associated interstitial lung disease study, and lack of significant difference between groups for secondary outcomes, were sticking points.Medscape Medical News (Source: Medscape Rheumatology Headlines)
Source: Medscape Rheumatology Headlines - July 26, 2019 Category: Rheumatology Tags: Rheumatology News Source Type: news
Higher oestrogen levels linked to scleroderma severity
Older men with severe scleroderma have higher oestrogen levels than postmenopausal women with scleroderma, according to research published inArthritis Research& Therapy.Science Daily (Source: Society for Endocrinology)
Source: Society for Endocrinology - June 10, 2019 Category: Endocrinology Source Type: news
Higher estrogen levels linked to more severe disease in scleroderma
(Medical University of South Carolina) Scleroderma is a connective tissue disease that hardens the skin and scars the organs. Older men with scleroderma had higher estrogen levels than healthy older men or postmenopausal women with scleroderma, report Medical University of South Carolina and University of Pittsburgh researchers in Arthritis Research& Therapy. Higher estradiol levels were associated with more severe disease and heart involvement in these men and, in those positive for the autoantibody Scl-70, a greater risk of death. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - June 5, 2019 Category: International Medicine & Public Health Source Type: news
Using New Autoantibodies in Rheumatic Disease: An Update Using New Autoantibodies in Rheumatic Disease: An Update
Dr Kevin Deane explains how recent advances are shining a light on the potential role that newer autoantibodies may play in the clinical care of RA, myositis, and scleroderma.Medscape Rheumatology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 23, 2019 Category: Consumer Health News Tags: Rheumatology Viewpoint Source Type: news
nintedanib slows pulmonary function loss in people with ssc-ild
Phase III study showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated ILD1Results of pivotal Phase III SENSCIS ®trial published today in the New England Journal of Medicine (NEJM) and presented at the American Thoracic Society Conference in Dallas, USAInterstitial lung disease (ILD) is a key driver of mortality in people living with systemic sclerosis (SSc) – also known as scleroderma – and the absence of approved treatment options constitutes a high unmet need2,3FDA grants priority review to application for regulatory approval for nintedanib in patients with system...
Source: Boehringer Ingelheim Corporate News - May 20, 2019 Category: Research Source Type: news
Exploring new treatments for autoimmune diseases
(Michigan Medicine - University of Michigan) A new grant will allow Michigan Medicine researchers to explore personalized approaches to treating autoimmune diseases such as scleroderma, lupus, rheumatoid arthritis and others. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 6, 2019 Category: International Medicine & Public Health Source Type: news
Hyaluronic Acid Contraindicated in Scleroderma Skin Ulcers Hyaluronic Acid Contraindicated in Scleroderma Skin Ulcers
While evidence shows hyaluronic acid-based products are effective for healing chronic skin wounds, they may produce significant negative effects in patients with scleroderma.Wounds (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 29, 2019 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news
Anti-Neutrophil Cytoplasmic Antibodies in Systemic Sclerosis Anti-Neutrophil Cytoplasmic Antibodies in Systemic Sclerosis
A new study examines the clinical associations of anti-neutrophil cytoplasmic antibodies in systemic sclerosis. What have we learned?Arthritis Research & Therapy (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - April 17, 2019 Category: Intensive Care Tags: Rheumatology Journal Article Source Type: news
France Bans Textured Breast Implants
France has banned several types of textured breast implants that have been linked to a rare form of cancer, and more countries appear to be following suit, including Canada and the Netherlands.
For years researchers have raised concern about the potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer, but France is the first country to ban the devices. The ban took effect on Friday and covers macro-textured implants and implants with a polyurethane coating. The National Agency for Safety of Medicines and Health Products (ANSM) in France notified manufa...
Source: MDDI - April 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Regulatory and Compliance Source Type: news
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF). (Source: World Pharma News)
Source: World Pharma News - March 26, 2019 Category: Pharmaceuticals Tags: Featured Boehringer Ingelheim Business and Industry Source Type: news
Biomarker for dcSSc Outcome ID'd (CME/CE)
(MedPage Today) -- Progressive skin fibrosis associated with lung deterioration, all-cause death in patients with diffuse cutaneous systemic sclerosis (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - March 22, 2019 Category: Primary Care Source Type: news
FDA Busts J & amp;J and Sientra Over Breast Implant Compliance
FDA busted two manufacturers of silicone gel-filled breast implants this week for failure to comply with post-approval study requirements.
The agency sent warning letters to Irvine, CA-based Mentor Worldwide, a unit of Johnson & Johnson, and to Santa Barbara, CA-based Sientra for deficiencies in each company's post-approval study for silicone breast implant approvals.
Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an ove...
Source: MDDI - March 20, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic connective tissue disease
Pulmonary fibrosis, or fibrosing interstitial lung disease (ILD), is a key driver of mortality in people living with SSc and constitutes a high unmet need
... Biopharmaceuticals, FDA, Regulatory Boehringer Ingelheim, nintedanib, interstitial lung disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 18, 2019 Category: Pharmaceuticals Source Type: news
