Company Product Description Indication Status
Abbvie, of North Chicago Rinvoq (upadacitinib) JAK inhibitor Psoriatic arthritis and ankylosing spondylitis EMA's Committee for Medicinal Products for Human Use recommended approval of the drug
Acceleron Pharma Inc., of Cambridge, Mass. Sotatercept Ligand trap for TGF-beta superfamily to rebalance BMPR-II signaling Pulmonary arterial hypertension European Commission granted orphan drug designation
Amag Pharmaceuticals Inc., of Waltham, Mass. Makena Hydroxyprogesterone caproate Preterm birth Company submitted its response to the FDA's notice of opportunity for a hearing regarding the agency's proposed withdraw of the drug
Antengene Ltd., of Shanghai ATG-010 (selinexor) Selective inhibitor of nuclear export Relapsed/refractory multiple myeloma China's NMPA accepted the IND for a 150-patient phase III study testing selinexor in combination with bortezomib and dexamethasone
Astrazeneca plc, of Cambridge, U.K. Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) Long-acting beta2-agonist. long-acting muscarinic antagonist and inhaled corticosteroid  Moderate to severe chronic obstructive pulmonary disease European Commission approved the drug
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co Ltd., of Tokyo Trastuzumab deruxtecan Antibody-drug conjugate targeting HER2 Unresectable or metastatic HER2-positive breast cancer EMA's Committee for Medicinal Products for Human Use recommended conditional  approval of the drug for patients who have received 2 or more prior anti-HER2 based regimens
Avelas Biosciences Inc., of San Diego Pegloprastide (AVB-620) Fluorescent marker Breast cancer surgery FDA granted breakthrough therapy designation
EMD Serono, part of Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York Bavencio (avelumab) Monoclonal antibody targeting PD-L1 First-line maintenance of locally advanced or metastatic urothelial carcinoma EMA's Committee for Medicinal Products for Human Use recommended approval of the drug for patients who are progression-free following platinum-based chemotherapy
Gamida Cell Ltd., of Boston Omidubicel Cell therapy Bone marrow transplant FDA indicated at a type B meeting that the company should generate additional data to demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites prior to requesting a pre-BLA meeting; company now plans to submit BLA in the second half of 2021
Gannex, a unit of Shanghai-based Ascletis Pharma Inc. ASC-42 Farnesoid X receptor agonist Nonalcoholic steatohepatitis FDA granted fast track designation
Graphite Bio Inc., of South San Francisco GPH-101  CRISPR-based gene editing of the sickle globin gene Severe sickle cell disease FDA cleared the IND for a phase I/II study; plans to start enrollment in early 2021
Legend Biotech Corp., of Somerset, N.J. LB-1901 Autologous CAR T targeting CD4 Relapsed or refractory T-cell lymphoma FDA cleared the IND for a phase I study designed to test the safety and tolerability of LB-1901 and to determine the recommended phase II dose
Mindmed Inc., of New York Lysergic acid diethylamide Psychedelic Anxiety disorder Completed a pre-IND meeting; plans to open an IND for a phase IIb study in August 2021
Open Orphan plc, of London, and Codagenix Inc., of Farmingdale, N.Y. COVI-VAC Intranasal SARS-CoV-2 vaccine COVID-19 prophylaxis U.K.'s MHRA approved the phase I study, which is expected to start in January 2021
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 mRNA-based vaccine COVID-19 prophylaxis FDA issued an emergency use authorization
Swedish Orphan Biovitrum AB, of Stockholm Doptelet (avatrombopag) Thrombopoietin receptor agonist Primary chronic immune thrombocytopenia EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the approval of the drug for patients who are refractory to other treatments

Notes

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