Company Product Description Indication Status
Acacia Pharma Group plc, of Cambridge, U.K. Byfavo (remimazolam) Ultra-short-acting, reversible intravenous benzodiazepine Sedative/anesthetic use during invasive medical procedures Approved by FDA for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Beigene Ltd., of Beijing Tislelizumab PD-1 inhibitor Hepatocellular carcinoma China NMPA's Center for Drug Evaluation accepted sNDA for treatment of previously treated unresectable disease
Biophytis SA, of Paris Sarconeos (BIO-101) Small molecule COVID-19 FDA accepted IND for phase II/III program assessing drug as potential treatment for acute respiratory failure associated with COVID-19
Eusa Pharma Inc., of Hemel Hempstead, U.K. Sylvant (siltuximab) IL-6 receptor antagonist COVID-19-associated acute respiratory distress syndrome FDA cleared protocol for phase III study of intravenous Sylvant plus standard of care (SOC ) vs. placebo plus SOC in about 400 hospitalized participants; primary endpoint is all-cause mortality at 28 days
Geron Corp., of Menlo Park, Calif. Imetelstat  Telomerase inhibitor Myelodysplastic syndrome EMA Committee for Orphan Medicinal Products issued positive opinion on orphan drug designation in indication
Metvital Inc., of San Diego Anhydrous enol-oxaloacetate AMP activated protein kinase stimulator Glioblastoma  FDA granted fast track designation to treat people with newly diagnosed disease
Mundipharma International Ltd., of Cambridge, U.K., and Napp Pharmaceuticals Ltd., of Cambridge, U.K. Invokana (canagliflozin) SGLT2 inhibitor  Diabetic kidney disease European Commission approved extended indication in people with type 2 diabetes
Rhythm Pharmaceuticals Inc., of Boston Setmelanotide Melanocortin-4 receptor agonist Obesity MAA submitted to EMA, which granted accelerated assessment, for treatment of pro-opiomelanocortin deficiency and leptin receptor deficiency obesity

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments