BioSpace News Archive

Chroma Medicine Strengthens Leadership with Addition of George Golumbeski to Board of Directors and John Maraganore as Strategic Advisor.

Ocugen, Inc. today announced that it is diversifying its innovative pipeline by introducing a Phase 3, cell therapy platform technology called NeoCart® (autologous chondrocyte-derived neocartilage).

In Eli Lilly and Company’s pivotal, Phase 3 LUCENT-2 study, patients with ulcerative colitis who responded to mirikizumab at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity, using a novel, patient-reported outcome measure.

Clinigen Limited, the global pharmaceutical services company, announces it has nearly doubled its US site capacity to better service large-scale clinical trials.

Dermavant Sciences announced that the U.S. Food and Drug Administration has approved VTAMA® cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults.

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the Company’s Abbreviated New Drug Application for Regadenoson injection, 0.08 mg/mL, 5mL Single Dose Pre-Filled Syringe.

CB Scientific. Inc., a designer, manufacturer, and distributor of non-invasive ambulatory cardiac monitoring products and services, announced that it has entered the regulatory testing phase for its updated myCam cardiac event monitoring device.

Tesis Biosciences , the leader in targeted genetic sequencing, has been selected by Pathways Health Partners (PHP), an accountable care organization (ACO) dedicated to solving the challenges facing healthcare today, to provide member practices with next-generation sequencing (NGS) testing and precision medicine services.

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara ®.

Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has initiated enrollment for a second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company’s critical care drug candidate, designated EB05.