Company Product Description Indication Status
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.

No Comments