Ultragenyx Pharmaceutical’s phase 3 study evaluating aceneuramic acid extended release (Ace-ER) in patients with GNE Myopathy (GNEM) failed to meet primary endpoint of showing a statistically significant difference in the upper extremity muscle strength composite score compared to placebo.
ViraCyte has announced publication of positive data from a Phase 2 clinical trial evaluating its most advanced T-cell immunotherapy product, Viralym-M.
Pfizer, along with Alliance Foundation Trials (AFT) and six other international cancer research groups, has commenced a phase 3 clinical study to assess palbociclib (Ibrance) for the treatment of patients with metastatic breast cancer.
Ovid Therapeutics announced it has randomized the first patient in its Phase 1b/2a clinical trial of TAK-935, also known as OV935, in collaboration with Takeda Pharmaceutical Company Limited.
Pluristem Therapeutics stated that a pilot study of its PLX-R18 cell therapy will be initiated by the US Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU).
The National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) have awarded a Small Business Initiative Research (SBIR) grant to Aradigm to study the treatment of two pulmonary non-tuberculous mycobacteria (PNTM) infections, Mycobacterium avium and Mycobacterium abscessus, with the company’s inhaled liposomal ciprofloxacin products Linhaliq and Lipoquin.
Ophthotech’s anti-PDGF therapy Fovista (pegpleranib) for treating wet age-related macular degeneration (AMD) has failed to meet the primary endpoint in a phase 3 trial.
Heron Therapeutics has reported positive outcome of a recent End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) regarding its investigational agent, HTX-011, to prevent postoperative pain for the first 72 hours post surgery.
Amylyx Pharmaceuticals, in collaboration with The ALS Association, ALS Finding a Cure, and the Massachusetts General Hospital, has dosed the first patient in the CENTAUR study, a Phase II clinical trial assessing the efficacy and safety of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS).
Zynerba Pharmaceuticals has reported that its cannabis-based epilepsy gel ZYN002 (cannabidiol [CBD] gel) has failed to meet the primary point in a phase 2 clinical trial.
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