FDA grants Breakthrough Therapy Designation for Roche ’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease

Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet ® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The study represented the first randomised controlled trial to exclusively enroll patients with progressive fibrosing uILD.“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people living with fibrotic lung diseases,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussing the data with the FDA with the hope of bringing our important medicine to those with uILD who are currently without a treatment option.” ILD is a term that broadly describes a diverse group of more than 200 types of rare pulmonary diseases. While ILDs share similar features, including cough and shortness of breath, each ILD has different causes, treatment approaches, and outlooks.[2] Approximately 10% of people living with ILD reviewed by a multidisciplinary team cannot be given a definitive diagnosis, even after a thorough investigation, and in these cases, patients are categorised as having uILD[3,4]. The Phase II data supporting Breakthrough Designation...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

Related Links:

Hello, Is Any one getting refunds from LA LAU CONSULTANTS, which paid for WREB patient. Now that it is all in Manikin, are you getting refunds from him? He is giving me lot of trouble, basically he does not want to return money. Please let me know any one having same problem. Thank you. Here is his address. LU LAU CONSULTANTS Eric Gonzales 2835 Inez Street Los Angeles, California 90023 United States 2133698640 lulaudc@gmail.com
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: International Dental Source Type: forums
Publication date: Available online 24 May 2020Source: Journal of Vascular and Interventional RadiologyAuthor(s): Kasey Halsey, Jing Wu, Chang Su, Ben Hsieh, Thomas Yi, Scott A. Collins, Benjamin Kimia, Paul J. Zhang, Terrance Healey, Zishu Zhang, Harrison X. Bai
Source: Journal of Vascular and Interventional Radiology - Category: Radiology Source Type: research
Publication date: Available online 24 May 2020Source: Journal of the American College of RadiologyAuthor(s): Donald Chan, Surav Sakya, Cory M. Pfeifer
Source: Journal of the American College of Radiology - Category: Radiology Source Type: research
Publication date: Available online 24 May 2020Source: European Journal of RadiologyAuthor(s): Lisa Loi, Ferdinand Zimmermann, Steffen Goerke, Andreas Korzowski, Jan-Eric Meissner, Katerina Deike-Hofmann, Anne Stieber, Peter Bachert, Mark Edward Ladd, Heinz-Peter Schlemmer, Sebastian Bickelhaupt, Sarah Schott, Daniel Paech
Source: European Journal of Radiology - Category: Radiology Source Type: research
ConclusionThe proposed multiparametric MRI-based SLICs+MTh method performs noninvasive assessment of NACT response in osteosarcoma that may improve cancer treatment monitoring, planning, and overall prognosis.Key Points• The simple linear iterative clustering supervoxels and Otsu multithresholding-based technique (SLICs+MTh) successfully estimates the proportion of necrosis, viable tumor, and edema in osteosarcoma in the course of chemotherapy.• The proposed technique is noninvasive and uses multiparametric MRI to measure necrosis as an indication of anticancer treatment response.• SLICs+MTh-based necrosis w...
Source: European Radiology - Category: Radiology Source Type: research
CONCLUSIONS: The average patient is middle aged (often male) with a history of subacute back pain, sometimes presenting fever and/or neurological damage on diagnosis. Acute phase reactants are frequently raised. Diabetes mellitus, endocarditis and immunosuppressed patients may have the worst chance of a good outcome, therefore these patients should be more carefully managed (always try to obtain an imaging-guided biopsy, correct antibiotic treatment, and a functional and clinical follow-up). PMID: 32446680 [PubMed - as supplied by publisher]
Source: Medicina Clinica - Category: General Medicine Tags: Med Clin (Barc) Source Type: research
Publication date: Available online 24 May 2020Source: Pathology - Research and PracticeAuthor(s): Tania Franceschini, Elisa Capizzi, Francesco Massari, Riccardo Schiavina, Michelangelo Fiorentino, Francesca Giunchi
Source: Pathology Research and Practice - Category: Pathology Source Type: research
Publication date: Available online 24 May 2020Source: Journal of American Association for Pediatric Ophthalmology and StrabismusAuthor(s): Sarah Hilkert Rodriguez, Sidney A. Schechet, Michael J. Shapiro, Michael P. Blair
Source: Journal of American Association for Pediatric Ophthalmology and Strabismus - Category: Opthalmology Source Type: research
Psychologists say anxiety and uncertainty prompt irrational decisions — like turning down a transplant when an organ becomes available.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Transplants Emergency Medical Treatment Coronavirus (2019-nCoV) Liver Fear (Emotion) Anxiety and Stress Cancer Heart your-feed-science your-feed-healthcare Source Type: news
The Trump administration ’s report to Congress sees states taking responsibility for coronavirus testing with federal guidance.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Coronavirus (2019-nCoV) Tests (Medical) United States Politics and Government States (US) Centers for Disease Control and Prevention Health and Human Services Department Trump, Donald J your-feed-science your-feed-healthcare Source Type: news
More News: Allergy & Immunology | Anorexia | Asthma | Avastin | Biotechnology | Cancer | Cancer & Oncology | Carbon Monoxide Poisoning | Cough | Cystic Fibrosis | Diabetes | Diarrhoea | Dyspepsia | Eating Disorders & Weight Management | Endocrinology | European Medicines Agency (EMA) | Food and Drug Administration (FDA) | Gastroenterology | Grants | Hives | Infectious Diseases | International Medicine & Public Health | Internet | Interstitial Lung Disease | Japan Health | Liver | Lung Cancer | Men | Opthalmology | Oral Cancer | Pharmaceuticals | Pulmozyme | Respiratory Medicine | Science | Skin | Spirometry | Sports Medicine | Statistics | Study | Switzerland Health | Tarceva | Urology & Nephrology | USA Health | WHO | Xolair