Company Product Description Indication Status
AIM Immunotech Inc., of Ocala, Fla. Ampligen  Ribonuclease stimulator; 2,5-oligoadenylate synthetase stimulator; TLR-3 agonist; polymerase co-factor VP35 inhibitor Healthy subjects (eventually COVID-19) Dutch local ethics committee approved starting the phase I AMP-COV-100 study testing repeated doses of Ampligen
Akan Biosciences LLC, of Germantown, Md. Stromel Adipose-derived stromal vascular fraction Osteoarthritis of the knee FDA accepted the IND for a study scheduled to start in March 2021
Astrazeneca plc, of Cambridge, U.K. COVID-19 Vaccine Astrazeneca/Covishield Adenovirus-based vaccine COVID-19 prophylaxis WHO granted emergency use listing for COVID-19 Vaccine Astrazeneca manufactured by Astrazeneca and Covishield manufactured by Serum Institute of India
Bristol Myers Squibb Co., of New York, and Acceleron Pharma Inc., of Cambridge, Mass. Reblozyl (luspatercept) Erythroid maturation agent Transfusion-dependent anemia due to very low-to intermediate-risk myelodysplastic syndromes Health Canada approved the drug
Celltrion Group, of Incheon, Korea Yuflyma (CT-P17) Adalimumab biosimilar Multiple chronic inflammatory diseases European Commission granted marketing authorization for the drug
Cortexyme Inc., of South San Francisco Atuzaginstat (COR-388) Gingipain inhibitor  Alzheimer’s disease FDA placed a partial clinical hold on the open-label extension of the phase II/III Gain trial due to hepatic adverse events; patients still in the Gain trial will continue receiving treatment; top-line results from Gain are expected in the fourth quarter of 2021
Cytocom Inc., of Fort Collins, Colo. CYTO-205 Modulates immune system function  COVID-19 Submitted IND to the FDA for a study that is scheduled to start in the second quarter of 2021
Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) Antibody-drug conjugate targeting HER2 Unresectable or metastatic HER2-positive breast cancer after 2 or more prior anti-HER2 based regimens Drug was granted conditional authorization in the U.K.
Forge Biologics Inc., of Columbus, Ohio FBX-101 AAV gene therapy Krabbe disease FDA granted fast track, orphan drug and rare pediatric disease designations
G1 Therapeutics Inc., of Research Triangle Park, N.C. Cosela (trilaciclib) Myelopreservation agent To reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for small-cell lung cancer FDA approved it
Jazz Pharmaceuticals plc, of Dublin Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution  GABA B receptor agonist  Idiopathic hypersomnia Completed the rolling submission of the sNDA to FDA
JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan JR-171 Form of recombinant α-L-iduronidase that penetrates the blood-brain barrier Mucopolysaccharidosis type I FDA granted orphan drug designation
Pfizer Inc., of New York Panzyga (immune globulin intravenous, human) Liquid preparation of immune globulin Chronic inflammatory demyelinating polyneuropathy FDA approved the sBLA
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany Comirnaty mRNA vaccine COVID-19 prophylaxis Pfizer Japan Inc. said Japan granted it special emergency use approval
Sesen Bio Inc., of Cambridge, Mass. Vicineum (oportuzumab monatox) EpCAM modulator BCG-unresponsive non-muscle invasive bladder cancer FDA accepted for filing the BLA
Signature Biologics LLC, of Dallas Signature Cord Prime Cryopreserved, human umbilical cord tissue allograft  Symptomatic osteoarthritis of the knee FDA approved the IND application to proceed with a clinical study
Swedish Orphan Biovitrum AB, of Stockholm Kineret (anakinra) Interleukin-1 receptor antagonist Cryopyrin associated periodic syndrome Approved in Russia 
Targovax ASA, of Oslo, Norway ONCOS-102 GM-CSF receptor agonist Malignant pleural mesothelioma FDA granted fast track designation 
Xenetic Biosciences Inc., of Framingham, Mass., and Pharmsynthez PJSC, of St. Petersburg, Russia Epolong Polysialylated form of recombinant human erythropoietin Anemia in patients with chronic kidney disease Pharmsynthez filed a registration dossier to obtain approval in Russia 

Notes

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