BioSpace News Archive

CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that the United States Food and Drug Administration has granted orphan drug designation to one of CARsgen’s first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma.

ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm.

Mavacamten Is a Potential First-in-Class Medicine with Compelling Data in the Treatment of Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Apellis Pharmaceuticals, Inc. announced that it has initiated registrational programs of pegcetacoplan, a targeted C3 therapy, for people living with C3 glomerulopathy or immune complex membranoproliferative glomerulonephritis, rare diseases that can lead to kidney failure within five to 10 years, and amyotrophic lateral sclerosis, a devastating neurodegenerative disease that leads to progressive muscle weakness and paralysis.

Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphine

Agreement Brings BridgeBio’s Clinical Development and Commercial Development Infrastructureto Bear Upon Eidos’Acoramidis, Creating Anticipated Value for Patients with ATTR and Investors

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing innovative medicines based on cancer cell biology, announces that the Company is scheduled to participate in a virtual presentation and fireside chat at the October 2020 Lytham Partners Virtual Investor Growth Conference on Thursday, October 8, 2020 at 8:00am ET.

Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, announced the U.S. Food and Drug Administration has granted an orphan-drug designation for EYS611 for the treatment of retinitis pigmentosa.

Principal deputy commissioner will address industrywide shift to adopt advanced technologies and modernize drug development

Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, announced participation in two upcoming conferences focused on HBV. ICE-HBV Serum Biomarkers Virtual Workshop 2020 Panel: What are the virological and immunological gaps that need to be addressed? What biomarkers are most needed to