BioSpace News Archive

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that data supporting additional positive clinical observations of IBSRELA® (tenapanor) was presented at the 2024 Digestive Disease Week Conference (DDW), currently taking place in Washington, D.C.

NewAmsterdam Pharma Company N.V announced that it will present new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society 92nd Congress and the National Lipid Association 2024 Scientific Sessions, taking place on May 26 – 29 in Lyon, France and May 30 – June 2 in Las Vegas, Nevada, respectively.

Bionano Genomics today announced the publication of three studies which collectively illustrate the continued development of data supporting the utility of optical genome mapping (OGM) in cell and gene therapy applications.

Provectus Biopharmaceuticals, Inc. announced posters were presented at the annual meeting of the Society for Investigative Dermatology (“SID”), held May 15-18, 2024 in Dallas, Texas.

Ractigen Therapeutics has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).

Elanco Animal Health Incorporated (NYSE: ELAN) will participate in the Stifel 2024 Jaws and Paws Conference on Wednesday, May 29, 2024.

In Eli Lilly and Company’s (NYSE: LLY) pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn’s disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful improvements across multiple clinical and endoscopic endpoints at one year with mirikizumab compared to placebo.

Johnson & Johnson today announced the first Phase 3 results for TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), which demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) versus placebo and ustekinumab.

Biocon Biologics Ltd today announced that the U.S. Food and Drug Administration (US FDA) has approved the Company’s first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept).

DURECT Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH).