|Algernon Pharmaceuticals Inc., of Vancouver, British Columbia||NP-120 (ifenprodil)||N-methyl-D-aspartate receptor antagonist||COVID-19||Submitted CTA to Health Canada for a phase IIb/III study enrolling 100 patients in the phase IIb portion; data from the phase IIb will determine the size of the phase III; primary endpoint is improvement in the ordinal clinical scale; secondary endpoints include mortality, blood oxygen levels, time in the ICU and time to mechanical ventilation|
|Biontech SE, of Mainz, Germany, and Pfizer Inc., of New York||BNT-162||mRNA COVID-19 vaccine||COVID-19 prophylaxis||German regulatory authority, the Paul-Ehrlich-Institut, approved the phase I/II study|
|Clarity Pharmaceuticals, of Sydney||67Cu-Sartate||Radiopharmaceutical||Neuroblastoma||FDA granted orphan drug designation|
|Janssen Biotech Inc., of Horsham, Pa., and Abbvie Inc., of North Chicago||Imbruvica (ibrutinib)||Bruton's tyrosine kinase inhibitor||Chronic lymphocytic leukemia or small lymphocytic lymphoma||FDA approved the drug in combination with rituximab|
|Mallinckrodt plc, of Staines-upon-Thames, U.K.||Terlipressin||Vasopressin analogue selective for V1 receptors||Hepatorenal syndrome type 1||FDA accepted the NDA and assigned a PDUFA date of Sept. 12, 2020|
|Novartis AG, of Basel, Switzerland||Kymriah (tisagenlecleucel)||CD19-targeting CAR T||Relapsed or refractory follicular lymphoma||FDA granted regenerative medicine advanced therapy designation|
|Vitro Diagnostics Inc., of Golden, Co.||Allorx stem cells||Umbilical cord-derived stem cells||COVID-19||Filed an IND with the FDA|
For more information about individual companies and/or products, see Cortellis.