MODERATE IMPACT - Although no detailed data were provided, Alexion/AstraZeneca showed positive topline results for the phase 3 open-label CHAMPION-NMOSD trial for Ultomiris. Ultomiris achieved a statistically significant and clinically…
HIGH IMPACT - Protalix and Chiesi announce topline results of Phase III BALANCE trial evaluating the safety and efficacy of PRX-102 in Fabry. Study: Phase III BALANCE study is a 12-month, randomized, double-blind, study of 1 mg/kg…
https://inthought.com/wp-content/uploads/2022/03/blank-transparent.png720720old adminhttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngold admin2022-04-04 00:00:372022-05-06 14:55:07Protalix's Phase III BALANCE trial of PRX-102 in Fabry meets endpoint and shows non-inferiority to Fabrazyme
HIGH IMPACT - Ardelyx has launched Ibsrela (tenapanor) for the treatment of IBS-C in adults. Ardelyx has also created a patient support program ArdelyxAssist. Ibsrela messaging highlights its different mechanisms of action, 3 way in which…
HIGH IMPACT - The FDA's Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) reviewed Amylyx's NDA for AMX0035 in ALS and voted that the current data do not support the efficacy for AMX0035 to treat ALS. Amylyx's FDA…
https://inthought.com/wp-content/uploads/2022/03/blank-transparent.png720720old adminhttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngold admin2022-03-30 00:00:042022-05-06 15:00:03FDA panel votes that current data do not support AMX0035 in ALS
MODERATE IMPACT - Servier has resubmitted an MAA to the EMA for its IDH1 inhibitor Tibsovo (ivosidenib) for use with azacitidine as a first-line treatment for patients with IDH1-mutated AML who are not eligible for intensive chemotherapy, and…
https://inthought.com/wp-content/uploads/2022/03/blank-transparent.png720720old adminhttps://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.pngold admin2022-03-14 00:00:532022-04-13 20:40:32Servier seeks EU approval for Tibsovo in unfit IDH1-mutated AML
HIGH IMPACT - At its 4Q/full-year 2021 earnings release, Voyager announced a license agreement with Novartis for the TRACER AAV capsids. Under the agreement, Novartis may exercise options to license novel AAV capsids generated from Voyager’s…