Company Product Description Indication Status
AB Science SA, of Paris Masitinib Tyrosine kinase inhibitor Moderate and severe COVID-19 Gained authorization from French Medicine Agency, ANSM, and started 200-patient study testing drug in combination with isoquercetin 
Antabio SAS, of Labege, France MEM-ANT-3310 Meropenem plus broad-spectrum serine beta-lactamase inhibitor ANT-3310 Complicated urinary tract infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated intra-abdominal infections FDA granted qualified infectious disease product designation for the 4 indications
Astrazeneca plc, of Cambridge, U.K. Farxiga (dapagliflozin) Sodium glucose co-transporter 2 inhibitor Heart failure with reduced ejection fraction with and without type 2 diabetes FDA approved the expanded indication
Bristol Myers Squibb Co., of New York Lisocabtagene maraleucel  CAR T targeting CD19 Relapsed or refractory large B-cell lymphoma after at least 2 prior therapies FDA extended the PDUFA date to Nov. 16, 2020, after company submitted an additional data package that was deemed a major amendment
Cabaletta Bio Inc., of Philadelphia DSG3-CAART  Targets B cells that express pathogenic anti-DSG3 autoantibodies Mucosal pemphigus vulgaris FDA granted fast track designation
Immunicum AB, of Stockholm Ilixadencel Activated allogeneic dendritic cells from donors Metastatic renal cell carcinoma FDA granted regenerative medicine advanced therapy designation
Interna Technologies BV, of Utrecht, The Netherlands INT-1B3 miR-193a-3p mimic Advanced solid tumors Received regulatory approvals in the Netherlands and Belgium for an 80-patient phase I study
Kiadis Pharma NV, of Amsterdam K-NK002  Natural killer cell therapy Blood cancer patients undergoing haploidentical hematopoietic stem cell transplant FDA approved start of the NK-REALM phase II study 
Laurent Pharmaceuticals Inc., of Montreal LAU-7b  Oral formulation of synthetic retinoid fenretinide COVID-19 Health Canada approved start of the 200-patient, phase II Resolution study in hospitalized subjects with COVID-19
Medivir AB, of Stockholm MIV-818  Nucleotide DNA polymerase inhibitor Hepatocellular carcinoma FDA granted orphan drug designation
Pulmotect Inc., of Houston PUL-042 Combination of 2 Toll-like receptor agonists COVID-19 prevention and treatment FDA approved the start of 2 phase II studies
Zia Lab Ltd., of Shanghai Nuzyra (omadacycline) Novel tetracycline Community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections China’s National Medical Products Administration granted priority review for the NDA

Notes

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

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