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. 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. 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...
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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
Publication date: Available online 24 May 2020Source: Journal of the American College of RadiologyAuthor(s): Donald Chan, Surav Sakya, Cory M. Pfeifer
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
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...
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]
Publication date: Available online 24 May 2020Source: Pathology - Research and PracticeAuthor(s): Tania Franceschini, Elisa Capizzi, Francesco Massari, Riccardo Schiavina, Michelangelo Fiorentino, Francesca Giunchi
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
Psychologists say anxiety and uncertainty prompt irrational decisions — like turning down a transplant when an organ becomes available.
The Trump administration ’s report to Congress sees states taking responsibility for coronavirus testing with federal guidance.
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