Company Product Description Indication Status
Abbvie Inc., of North Chicago Venclyxto (venetoclax) B-cell lymphoma-2 inhibitor Newly diagnosed acute myeloid leukemia EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application
ADC Therapeutics SA, of Lausanne, Switzerland Zynlonta (loncastuximab tesirine-lpyl) Antibody-drug conjugate targeting CD19 Relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy FDA granted accelerated approval of the drug
Biogen Inc., of Cambridge, Mass. Aducanumab Monoclonal antibody targeting amyloid-beta Alzheimer’s disease Submitted MAAs to ANVISA in Brazil, Health Canada, the
Therapeutic Goods Agency in Australia and Swissmedic in Switzerland
Bristol Myers Squibb Co., of New York Onureg (azacitidine) Hypomethylating agent Acute myeloid leukemia after complete remission or complete remission with incomplete blood count recovery following induction therapy EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application for use of the drug as a maintenance therapy
Bristol Myers Squibb Co., of New York Opdivo (nivolumab); Yervoy (ipilimumab) Monoclonal antibodies targeting PD-1 and CTLA-4 First-line, unresectable, malignant pleural mesothelioma EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application
Calliditas Therapeutics AB, of Stockholm Nefecon Oral formulation of budesonide IgA nephropathy EMA’s Committee for Medicinal Products for Human Use granted accelerated assessment procedure
Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J. Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab)  Receptor tyrosine kinase inhibitor and monoclonal antibody targeting PD-1 Advanced uterine body cancer Submitted marketing application to Japan’s Pharmaceuticals and Medical Devices Agency
Gilead Sciences Inc., of Foster City, Calif., and Eisai Co. Ltd., of Tokyo Filgotinib   Janus kinase inhibitor Moderately to severely active ulcerative colitis Submitted marketing application to Japan’s Pharmaceuticals and Medical Devices Agency
Glaxosmithkline plc, of London Jemperli (dostarlimab-gxly) PD-1 blocking antibody Mismatch repair-deficient recurrent or advanced endometrial cancer FDA approved the drug for use after progression on a platinum-containing regimen
Hua Medicine Ltd., of Shanghai Dorzagliatin  Glucokinase stimulator  Type 2 diabetes China's National Medical Products Administration accepted the NDA
Leo Pharma A/S, of Ballerup, Denmark Adtralza (tralokinumab) Monoclonal antibody targeting interleukin-13 Moderate to severe atopic dermatitis EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application
Medicago Inc., of Quebec City CoVLP Plant-derived adjuvanted COVID-19 vaccine COVID-19 prophylaxis Submitted the first portion of the rolling submission to Health Canada
Protara Therapeutics Inc., of New York TARA-002  Cell-based therapy based on immunopotentiator OK-432  Lymphatic malformations Based on feedback from the FDA, the company plans to run a manufacturing comparability study in the second half of 2021 and then run a study in pediatric patients after gaining alignment with the FDA on the study design
Roche Holding AG, of Basel, Switzerland Enspryng (satralizumab) Monoclonal antibody targeting interleukin-6 Anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing application
Roche Holding AG, of Basel, Switzerland Ventana MMR DxDx Immunohistochemistry test for DNA mismatch repair biomarkers Advanced or recurrent endometrial cancer FDA approved the companion diagnostic test for Jemperli (dostarlimab-gxly, Glaxosmithkline plc)
Shanghai Henlius Biotech Inc., of Shanghai Serplulimab (HLX-10) Monoclonal antibody targeting PD-1 Unresectable or metastatic microsatellite instability-high solid tumors unresponsive to standard therapy China National Medical Products Administration accepted the NDA
Shorla Pharma Ltd., of Clonel, Ireland SH-111 Undisclosed drug based on a standard-of-care treatment T-cell leukemia FDA accepted the marketing application and granted a priority review

Notes

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