Company Product Description Indication Status
Acasti Pharma Inc., of Laval, Quebec Capre (omega-3 phospholipid) Phospholipid derived from krill oil Hypertriglyceridemia In a written response to a type C meeting, the FDA said post-hoc analysis from the Trilogy 1 study may be used for exploratory purposes; depending on the outcome of Trilogy 2 study, an additional clinical trial may be required before submission of an NDA
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion Low-molecular-weight fraction of 5% human serum albumin  COVID-19 patients on supplemental oxygen FDA cleared the IND for a phase I study
Ascentage Pharma Group International, of Suzhou, China HQP-1351   T315I-mutant chronic phase chronic myeloid leukemia and accelerated phase CML Bcr-Abl inhibitor  Submitted NDA to the Center for Drug Evaluation of China National Medical Products Administration
Beigene Ltd., of Beijing Tislelizumab Monoclonal antibody targeting PD-1 First-line treatment nonsquamous non-small-cell lung cancer Center for Drug Evaluation of the China National Medical Products Administration accepted the supplemental NDA
Innovent Biologics Inc., of Suzhou, China Byvasda (bevacizumab) Biosimilar to Avastin (bevacizumab), an anti-VEGF monoclonal antibody  Advanced non-small-cell lung cancer and metastatic colorectal cancer Center for Drug Evaluation of the China National Medical Products Administration approved the drug
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J. Fexapotide triflutate Pro-apoptotic protein Benign prostatic hyperplasia On track to file marketing applications in the U.S. and EU approximately by the end of the third quarter or early fourth quarter of 2020
Ovid Therapeutics Inc., of New York OV-101 (gaboxadol) Delta-selective GABAA Angelman syndrome  FDA granted rare pediatric disease designation
Plakous Therapeutics Inc., of Winston-Salem, N.C. Protego-PD  Acellular biotherapeutic from post-delivery placentas Necrotizing enterocolitis prophylaxis FDA granted orphan drug designation
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase-2 inhibitor Hospitalized COVID-19 patients with pneumonia Submitted CTAs to the U.K. Medicines & Healthcare Products Regulatory Agency and the Italian Medicines Agency for a phase II/III study
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Dupixent (dupilumab) Monoclonal antibody that inhibits the signaling of IL-4 and IL-13 Moderate to severe atopic dermatitis Center for Drug Evaluation of the China National Medical Products Administration approved the drug

Notes

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

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