Company Product Description Indication Status
Bristol Myers Squibb Co., of New York, and Acceleron Pharma Inc., of Cambridge, Mass. Reblozyl (luspatercept-aamt) Erythroid maturation agent Myelodysplastic syndromes Approved by FDA for treatment of anemia failing an erythropoiesis-stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adults with very low- to intermediate-risk MDS with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis 
Daiichi Sankyo Europe GmbH, of Munich, Germany Nilemdo (bempedoic acid) ATP citrate lyase inhibitor Primary hypercholesterolemia or mixed dyslipidemia Approved by European Commission for use in adults
Daiichi Sankyo Europe GmbH, of Munich, Germany Nustendi (bempedoic acid/ezetimibe) ATP citrate lyase inhibitor plus cholesterol absorption inhibitor Primary hypercholesterolemia or mixed dyslipidemia Approved by European Commission for use in adults
Eisai Co. Ltd., of Tokyo Dayvigo (lemborexant) Binds to orexin receptors OX1R and OX2R  Insomnia Drug Enforcement Administration issued interim final rule placing lemborexant in schedule IV of the Controlled Substances Act
GW Pharmaceuticals plc, of Carlsbad, Calif. Epidiolex Cannabidiol Lennox-Gastaut and Dravet syndromes Received notification from U.S. Drug Enforcement Administration confirming drug is no longer subject to Controlled Substances Act; change takes effect immediately
Histogen Inc., of San Diego HST-001 Hair-stimulating complex Androgenic alopecia Submitted IND to FDA for a phase Ib/IIa trial in men
Hope Biosciences LLC, of Houston HB-adMSCs Autologous, adipose-derived mesenchymal stem cells COVID-19 FDA cleared the IND for a phase II trial for protection against COVID-19
Mallinckrodt plc, of Staines-upon-Thames, U.K. Stratagraft  Regenerative skin tissue therapy Deep partial-thickness thermal burns Initiated rolling BLA submission to FDA
Mateon Therapeutics Inc., of Agoura Hills, Calif. OT-101 Phosphorothioate antisense oligodeoxynucleotide targeting human TGF-β2 mRNA COVID-19 Submitted pre-IND package to FDA to allow referencing of OT-101’s oncology IND to streamline submission for testing in COVID-19
Mesoblast Ltd., of Melbourne, Australia Remestemcel-L Allogeneic mesenchymal stem cell product COVID-19 FDA cleared IND for testing in patients with acute respiratory distress syndrome caused by coronavirus infection
Novo Nordisk A/S, of Bagsvaerd, Denmark Rybelsus (oral semaglutide) GLP-1 analogue Type 2 diabetes European Commission granted marketing authorization for use in treating adults with insufficiently controlled disease to improve glycemic control as an adjunct to diet and exercise
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Alunbrig (brigatinib) Next-generation tyrosine kinase inhibitor targeting ALK genetic alterations ALK-positive advanced non-small-cell lung cancer European Commission approved extension of marketing application to include use as monotherapy for treating patients not previously treated with an ALK inhibitor
Tetra Bio-Pharma Inc., of Ottawa HCC-011 Inhaled delta-9-tetrahydrocannabinol Hepatocellular carcinoma FDA granted request for type B meeting, set for May 29, 2020, to discuss clinical and premarketing requirements for use as adjunct treatment to first-line therapy to improve disease control in patients with inoperable, advanced disease
Tracon Pharmaceuticals Inc., of San Diego Envafolimab Single-domain antibody against PD-L1 Sarcoma FDA granted company a type B teleconference May 8, 2020, to discuss trial design for a potential pivotal study

Notes

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

No Comments