FDA Lifts Clinical Hold on Immunome’s IMM-BCP-01 IND Application for the Treatment of COVID-19
News
Venatorx Pharmaceuticals Announces Positive Results for Phase 3 Clinical Trial (CERTAIN-1) of Cefepime-Taniborbactam for Treatment of cUTI
Cefepime-taniborbactam met the primary noninferiority efficacy endpoint and demonstrated statistical superiority to meropenem
Cefepime-taniborbactam was well-tolerated with similar safety profile to meropenem
NDA on track to be submitted in the fourth quarter 2022
Renovacor Announces Partnerships with the Dilated Cardiomyopathy Foundation, the Heart Failure Society of America and the American Association of Heart Failure Nurses to Help Increase Awareness of Genetic Heart Disorders
Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Ketamine for Abuse Potential
– All doses of REL-1017, including the maximum tolerated dose, demonstrated a statistically significant difference in abuse potential vs. ketamine (p-values <0.05)
– All doses of REL-1017, including the maximum tolerated dose, were statistically equivalent to placebo (p-values <0.05)
– Company to host conference call at 8:30 AM Eastern Time today, February 23, 2022
InfraScan announces FDA clearance of the first hand-held diagnostic device for Traumatic Brain Hemorrhage in children
InfraScanner is now the only hand-held device cleared by the FDA to detect Traumatic Brain Hemorrhage in children
Immunome’s Antibody Cocktail Effective Against SARS-CoV-2 Omicron Variant in In Vitro Live Virus Testing
– Antibody Cocktail Demonstrates Comparable Head-to-Head Potency to GSK/Vir’s Sotrovimab in Live Virus Neutralization Assay Against Omicron (B.1.1.529) –
– IMM20253 Antibody Exhibits a Novel Mechanism of Action –
Annovis Bio Announces Positive FDA Feedback for Buntanetap Phase 3 Clinical Development in Parkinson’s Disease
FDA gives guidance for two Phase 3 clinical trials of Buntanetap in Parkinson’s Disease
Halo Labs Launches New Instruments for Protein, Cell, and Gene Therapy Developers
Aura PTx analyzes degraded excipients in protein therapeutics, and Aura+ is an all-in-one drug product quality tool for mAb, cell, and gene therapy
ASHP Innovation Center and Bainbridge Health Collaborate to Improve Patient Safety, Increase Use of Standardized Medication Concentrations in Health Systems
Immunome Provides Update on Investigational New Drug Application for IMM-BCP-01 for the Treatment of COVID-19
• Immunome has received a clinical hold letter from the FDA requesting further information related to the preparation and administration of the IMM-BCP-01 cocktail at clinical sites
• Immunome expects to provide the requested information soon and remains on track to generate top-line clinical data for IMM-BCP-01 in the first half of 2022
• Reporting of IMM-BCP-01 activity against the Omicron variant in live virus testing by an external laboratory also remains on track for this month