Company Product Description Indication Status
ADC Therapeutics SA, of Lausanne, Switzerland Loncastuximab tesirine Antibody-drug conjugate targeting CD19 Relapsed or refractory diffuse large B-cell lymphoma FDA accepted the BLA with a priority review; PDUFA target action date is 5/21/21
Alexion Pharmaceuticals Inc., of Boston Ultomiris (ravulizumab) Long-acting C5 inhibitor Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome European Commission approved a 100-mg/mL intravenous formulation
Astrazeneca plc, of Wilmington, Del. Imfinzi (durvalumab) Antibody targeting PD-L1  Unresectable Stage III non-small-cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer FDA approved dosing option of 1,500-mg fixed dose every 4 weeks
Beigene Co., Ltd., of Beijing and Cambridge, Mass., and Amgen Inc., of Thousand Oaks, Calif. Xgeva (denosumab) Antibody targeting RANKL Prevention of skeletal-related events in patients with bone metastases from solid tumors and in patients with multiple myeloma China National Medical Products Administration approved the drug
Eli Lilly and Co., of Indianapolis Baricitinib  Monoclonal antibody targeting SARS-CoV-2 COVID-19 patients who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation FDA issued an emergency use authorization
Gilead Sciences Inc., of Foster City, Calif. Veklury (remdesivir) Antiviral COVID-19 The WHO Guideline Development Group panel advises against use of the drug due to lack of evidence that it has an effect on mortality, the need for mechanical ventilation or time to clinical improvement
Immupharma plc., of London Lupuzor Modulates activation of autoreactive T cells Systemic lupus erythematosus FDA scheduled a type A meeting for 12/4/20 to discuss the design of a phase III study and the potential for a conditional approval before the phase III study is completed
Pfizer Inc., of New York and Biontech SE, of Mainz, Germany BNT-162b2  mRNA-based vaccine targeting SARS-CoV-2 COVID-19 prophylaxis Submitted application for EUA to the FDA on 11/20/20; rolling submissions already initiated in Australia, Canada, Europe, Japan and the U.K.


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

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