BioSpace News Archive

Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.

Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.

Cytokinetics, Incorporated announced new data on symptom improvement and quality of life related to treatment with aficamten in REDWOOD-HCM OLE in a Late Breaking Clinical Trials session at the Heart Failure Society of America Annual Scientific Meeting in Washington, D.C.

Horizon Therapeutics plc announced the presentation of new data defining molecular patterns in TED and further implicating the role of insulin-like growth factor-1 in patients with low CAS.

Sumitovant Biopharma Ltd., in conjunction with parent company Sumitomo Pharma Co., Ltd., announced it has submitted a non-binding proposal to the Audit Committee of the Board of Directors of Myovant Sciences Ltd. offering to acquire all outstanding shares of Myovant not already owned by Sumitovant for $22.75 per share in cash.

Myovant Sciences Ltd. confirmed that it has received a preliminary, non-binding proposal from Sumitovant Biopharma Ltd. and Sumitomo Pharma Co., Ltd. to acquire the remaining shares of the Company that Sumitovant does not currently hold, for a price of $22.75 per share in cash.

Mesoblast Limited announced that it has submitted to the U.S. Food and Drug Administration substantial new information on clinical and potency assay items identified in the Complete Response Letter received from FDA in September 2020 to the Biologics License Application for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.

Lexicon Pharmaceuticals, Inc. announced that a new analysis of results from the SOLOIST-WHF Phase 3 outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the Heart Failure Society of America Annual Scientific Meeting 2022.

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer.