Company Product Description Indication Status
Alexion Pharmaceuticals Inc., of Boston Ultomiris (ravulizumab)  Long-acting C5 inhibitor Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on a new 100-mg/mL intravenous formulation
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion Aryl hydrocarbon receptor agonist; stem cell antigen-1 inhibitor Respiratory distress due to COVID-19 FDA cleared an IND for a phase I study of 40 patients
Arca Biopharma Inc., of Westminster, Colo. AB-201   Inhibitor of tissue factor Hospitalized COVID-19 Submitted IND to FDA for a phase IIb/III study
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Metastatic castration-resistant prostate cancer  EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the application seeking use in patients with BRCA1/2 mutations after progression following a prior therapy that included a new hormonal agent
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Advanced, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer  EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the  application to approve the drug in combination with bevacizumab in patients with tumors that have a BRCA1/2 mutation and/or genomic instability who have responded to a completed first-line platinum-based chemotherapy
Crinetics Pharmaceuticals Inc., of San Diego CRN-04777 Non-peptide somatostatin receptor type 5 agonist Congenital hyperinsulinism FDA granted rare pediatric disease designation
Harbour Biomed Therapeutics Ltd., of Suzhou, China HBM-4003 Anti-CTLA4 antibody Advanced solid tumors China National Medical Products Administration approved 2 INDs for phase I studies of the drug as a monotherapy and in combination with Tuoyi (toripalimab)
I-Mab Biopharma Co. Ltd., of Shanghai Lemzoparlimab  Anti-CD47 monoclonal antibody Relapsed or refractory advanced lymphoma Center for Drug Evaluation of the China National Medical Products Administration cleared the IND for a phase I study
Liminal Biosciences Inc., of Laval, Quebec Ryplazim (plasminogen)  Recombinant protein Congenital plasminogen deficiency FDA received the BLA resubmission by its U.S. subsidiary, Prometic Biotherapeutics Inc., and assigned a PDUFA target action date March 5, 2021
Otsuka Novel Products GmbH, of Munich Deltyba (delamanid)  Inhibits the synthesis of mycolic acid Pulmonary multidrug-resistant tuberculosis EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the extension of the indication to include adolescents and children with a body weight of at least 30 kg

Notes

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