Company Product Description Indication Status
Acer Therapeutics Inc., of Newton, Mass. Edsivo (celiprolol) Beta blocker Vascular Ehlers-Danlos syndrome with a confirmed COL3A1 mutation FDA denied company's appeal of the CRL issued in June 2019
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza  PARP inhibitor Maintenance treatment of germline BRCA-mutated, curatively unresectable, pancreatic cancer Japanese Ministry of Health, Labor and Welfare granted orphan drug designation
Cansino Biologics Inc., of Tianjin, China Ad5-nCoV Recombinant coronavirus vaccine COVID-19 prophylaxis Vaccine approved to enter phase I study in China
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist COVID-19 FDA granted emergency IND for 2 patients
Dicerna Pharmaceuticals Inc., of Lexington, Mass. DCR-A1AT RNAi targeting SERPINA1 Alpha-1 antitrypsin deficiency FDA granted orphan drug designation
Gilead Sciences Inc., of Foster City, Calif. Epclusa (sofosbuvir and velpatasvir) HCV NS5B polymerase inhibitor and HCV NS5A inhibitor Hepatitis C virus FDA approved supplemental application to expand use for children, ages 6 and older and weighing at least 37 pounds, with any of the 6 HCV genotypes without cirrhosis or with mild cirrhosis; Epclusa plus ribavirin is indicated for treating pediatric patients, 6 and older and weighing at least 37 pounds, with severe cirrhosis
Hansoh Pharmaceutical Group Co. Ltd., of Shanghai Ameile (almonertinib) EGFR tyrosine kinase inhibitor Metastatic non-small-cell lung cancer  National Medical Products Administration in China granted marketing authorization for use in patients with an EGFR T790M mutation after progression on other EGFR TKI
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Ponesimod  Sphingosine-1-phosphate receptor 1 modulator Relapsing multiple sclerosis NDA submitted to the FDA
Novartis AG, of Basel, Switzerland Zolgensma (onasemnogene abeparvovec) Gene therapy expressing SMN Spinal muscular atrophy Japanese Ministry of Health, Labor and Welfare approved the therapy in patients under the age of 2
Oramed Pharmaceuticals Inc., of New York ORMD-0801 Oral insulin Type 2 diabetes At the end-of-phase-II meeting, the FDA gave feedback on issues for drug product manufacturing; company plans an additional meeting to go over phase III design
Takis Biotech Srl, of Rome, and Applied DNA Sciences Inc., of Stony Brook, N.Y. COVID-19 vaccine DNA vaccine COVID-19 prophylaxis Italy’s Ministry of Health approved the start of preclinical testing
Virpax Pharmaceuticals Inc., of West Chester, Pa. Epoladerm (diclofenac epolamine) Metered-dose topical aerosol of diclofenac epolamine Osteoarthritis of the knee Completed pre-IND meeting with the FDA, which agreed that the 505(b)(2) pathway is a reasonable approach for approval

Notes

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

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