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Dupixent (dupilumab) / Sanofi, RegeneronDUPIXENT (DUPILUMAB) LONG-TERM DATA SHOW SUSTAINED IMPROVEMENT IN LUNG FUNCTION AND REDUCTION IN SEVERE EXACERBATIONS IN ADULTS AND ADOLESCENTS WITH MODERATE-TO-SEVERE ASTHMA (Regeneron Pharmaceuticals Press Release) - Sep 8, 2020 - P3, N=2,285; LIBERTY ASTHMA TRAVERSE (NCT02134028); Sponsor: Sanofi; "Regeneron...and Sanofi today announced new results from a Dupixent® (dupilumab) Phase 3 open-label extension trial that showed the safety and efficacy profile observed in previous Dupixent trials was maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress...Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis."Zynrelef (bupivacaine/meloxicam ER) / Heron TherapeuticsHeron Therapeutics Announces Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain (PRNewswire) - Sep 8, 2020 - "Heron Therapeutics, Inc....today announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year....'We expect to resubmit the HTX-011 NDA in the next few months and appreciate the FDA's commitment to an expeditious review for this Breakthrough Therapy product.'"Erbitux (cetuximab) / Eli Lilly, EMD Serono; Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, PfizerNICE no for Pierre Fabre's Braftovi (PharmaTimes) - Sep 8, 2020 - "The National Institute for Health and Care Excellence has published the outcome of an appraisal of Pierre Fabre's Braftovi (encorafinib), turning down NHS funding for the drug as a treatment for some patients with advanced colorectal cancer....In preliminary guidelines, the Institute said it is not recommending NHS use of Braftovi in combination with cetuximab for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment."Panaecin (gallium citrate) / AridisAridis Announces Agreement with the FDA on Updated Phase 2 Clinical Trial Design for AR-501 (PRNewswire) - Sep 8, 2020 - "Aridis...today announced it has reached an agreement with the US Food and Drug Administration (FDA) to simplify the Company's AR-501 Phase 2 trial design for the treatment of chronic lung infections associated with cystic fibrosis (CF)...the FDA also concurred with the Company's proposal to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study. This Phase 2a/2b design will enable seamless and efficient advancement of the study from Phase 2a into Phase 2b using the same clinical study protocol...'We look forward to initiating the Phase 2a trial in the coming months and anticipate completing the study towards the end of 2021.'"Kinaction (masitinib) / AB ScienceAB Science to present results from its Phase 3 AB07015 study in severe asthma at the annual European Respiratory Society International Congress (GlobeNewswire) - Sep 8, 2020 - P3, N=420; NCT01449162; Sponsor: AB Science; "AB Science to present results from its Phase 3 AB07015 study in severe asthma at the annual European Respiratory Society International Congress. Abstract selected for moderated ALERT session (Abstracts Leading to Evolution in Respiratory Medicine Trials) held on 8th September, 2020....This ALERT abstract will also be presented in the e-poster format on the congress platform and the abstract will be published in a supplement (September 2020 edition) of the European Respiratory Journal."
