Company Product Description Indication Status
Adamas Pharmaceuticals Inc., of Emeryville, Calif. Gocovri (amantadine) Reduces the amount of glutamate hyperactivity  Parkinson’s disease FDA accepted the supplemental NDA as treatment of off episodes in patients receiving levodopa; PDUFA action date is Feb. 1, 2021
Aicuris Anti-infective Cures GmbH, of Wuppertal, Germany Pritelivir Inhibits viral helicase-primase complex Acyclovir-resistant mucocutaneous herpes simplex virus FDA granted breakthrough therapy designation
Baylx Inc., of Irvine, Calif. BX-U001 Umbilical cord tissue mesenchymal stem cells  Rheumatoid arthritis FDA cleared the IND
Genmab A/S, of Copenhagen, Denmark Darzalex (daratumumab) Monoclonal antibody targeting CD38 Multiple myeloma European Commission granted marketing authorization for the subcutaneous fixed-dosed formulation of the drug
Macrogenics Inc., of Rockville, Md. Margetuximab Fc-engineered monoclonal antibody targeting HER2 Gastric and gastroesophageal junction cancer FDA granted orphan drug designation
Merck & Co. Inc., of Kenilworth, N.J. Recarbrio (imipenem, cilastatin and relebactam) Carbapenem antibacterial, renal dehydropeptidase inhibitor and a beta-lactamase inhibitor Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia FDA approved the expanded indication
Moleculin Biotech Inc., of Houston Annamycin  Next-generation anthracycline Acute myeloid leukemia Submitted requests to Polish regulatory authorities for approval to open 2 additional clinical sites for the ongoing phase I/II study
Mylan NV, of Hertfordshire, U.K., and Lupin Ltd., of Mumbai Nepexto  Biosimilar to Enbrel (etanercept) Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and pediatric plaque psoriasis European Commission granted marketing authorization for the biosimilar
Oncolys Biopharma Inc., of Tokyo Telomelysin Genetically modified type 5 adenovirus targeting cancer cells Esophageal cancer FDA granted orphan drug designation
Pharmaessentia Corp., of Burlington, Mass. Ropeginterferon alfa-2b (P-1101) Pegylated interferon Polycythemia vera FDA accepted the BLA; decision expected in early 2021
Polyneuron Pharmaceuticals AG, of Basel, Switzerland PN-1007 Mimics the HNK-1 carbohydrate epitope found on myelin of peripheral nerves Anti-MAG neuropathy FDA granted orphan drug designation

Notes

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

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