Company Product Description Indication Status
Anixa Biosciences, Inc., of San Jose, Calif. Ovarian cancer CAR-T CAR T targeting follicle stimulating hormone receptor Ovarian cancer Filed an IND with the FDA
Citrine Medicine Inc., of Shanghai Wakix (pitolisant) Histamine 3 receptor antagonist/inverse agonist Narcolepsy  Received a clinical trial waiver from the National Medical Products Administration in China
Cybrexa Therapeutics Inc., of New Haven, Conn. CBX-12 (alphalex-exatecan) pH-low insertion peptide linked to a topoisomerase I inhibitor Solid tumors FDA cleared IND for a phase I study expected to begin in April 2021
Everest Medicines Ltd., of Shanghai Xerava (eravacycline) Broad-spectrum parenteral antibiotic of the tetracycline class Complicated intra-abdominal infections China National Medical Products Administration accepted the NDA
Genix Pharmaceuticals Corp., of Vancouver, British Columbia 10 generic ophthalmic drugs Various Various Entered into an agreement with a regulatory consulting company to prepare and file abbreviated new drug submissions with Health Canada
Jar of Hope, of West Long Branch, N.J. JAR-914 Undisclosed Duchenne muscular dystrophy FDA cleared the IND
Odonate Therapeutics, of New York Tesetaxel  Taxane chemotherapy Metastatic breast cancer Following feedback from the FDA in a pre-NDA meeting, the company concluded the clinical data package for tesetaxel is unlikely to support FDA approval and plans to stop development of the drug
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Cameroon approved the vaccine
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Mauritius approved the vaccine
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Food and Drug Administration of the Republic of the Philippines approved the vaccine
Redhill Biopharma Ltd., of Tel Aviv, Israel Opaganib Sphingosine kinase-2 selective inhibitor COVID-19 pneumonia Treating several patients in Switzerland under a compassionate use exemption
Regenerx Biopharmaceuticals Inc., of Rockville, Md. RGN-259 Thymosin beta 4 ligand; eye drops Dry eye syndrome Exploring the possibility of requesting a pre-BLA meeting with the FDA to discuss data from the Arise-3 study
Sesen Bio Inc., of Cambridge, Mass., and Qilu Pharmaceutical Ltd., of Jinan, China Vicineum  Fusion protein that targets epithelial cell adhesion molecule antigens to deliver pseudomonas exotoxin A BCG-unresponsive non-muscle invasive bladder cancer Center for Drug Evaluation of the China National Medical Products Administration approved the IND
Sirtex Medical, of Woburn, Mass. SIR-Spheres Y-90 Radioactive resin microspheres Unresectable hepatocellular carcinoma FDA cleared the Doorway90 study
Starton Therapeutics Inc., of Paramus, N.J. STAR-LLD Subcutaneously lenalidomide Chronic lymphocytic leukemia Based on feedback from a type B pre-IND meeting with the FDA, company plans to run a phase I bioavailability study comparing STAR-LLD to Revlimid (lenalidomide, Bristol Myers Squibb Co.) scheduled to start in the fourth quarter of 2021

Notes

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