Company Product Description Indication Status
Athenex Inc., of Buffalo, N.Y., and Almirall SA, of Barcelona, Spain Tirbanibulin ointment Src kinase inhibitor Actinic keratosis EMA accepted filing of the MAA
Cerovene Inc., of Valley Cottage, N.Y. Generic of Daraprim (pyrimethamine) tablets Dihydrofolate reductase inhibitor Toxoplasmosis FDA approved first generic for treating infection caused by Toxoplasma gondii when used with a sulfonamide
Cyclo Therapeutics Inc., of Alachua, Fla. Trappsol Cyclo Formulation of hydroxypropyl beta cyclodextrin Niemann-Pick disease type C1 Received feedback from type C meeting with FDA on global pivotal trial design; plans to meet with EMA in the second quarter of 2020
Janssen Pharmaceutical Inc., of Raritan, N.J., part of Johnson & Johnson, and Meiragtx Holding plc, of London AAV-RPGR Gene therapy X-linked retinitis pigmentosa EMA granted both PRIME (Priority Medicines) and advanced therapy medicinal product designations
Mallinckrodt plc, of Staines-upon-Thames, U.K. Terlipressin Vasopressin analogue selective for V1 receptors Hepatorenal syndrome type 1 Initiated rolling submission of NDA to FDA; expects to complete submission in the coming months
Morphosys AG, of Planegg, Germany Tafasitamab Anti-CD19 antibody Relapsed or refractory diffuse large B-cell lymphoma BLA accepted by FDA, with agency granting priority review; PDUFA date of Aug. 30, 2020
Pfizer Inc., of New York, and Eli Lilly and Co., of Indianapolis Tanezumab  NGF-inhibiting monoclonal antibody Chronic pain due to moderate to severe osteoarthritis FDA accepted BLA seeking approval for use in patients who have experienced inadequate pain relief with other analgesics
Prevail Therapeutics Inc., of New York PR-006 AAV-based gene therapy Frontotemporal dementia FDA accepted IND for a phase I/II trial in patients with GRN mutation
Sanofi SA, of Paris Sarclisa (isatuximab-irfc) CD38-targeting monoclonal antibody Relapsed multiple myeloma Approved by FDA for use in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Alunbrig (brigatinib) ALK-targeting tyrosine kinase inhibitor ALK-positive non-small-cell lung cancer EMA’s Committee for Medicinal Products for Human Use recommended approval for use in patients not previously treated with an ALK inhibitor
Virpax Pharmaceuticals Inc., of Malvern, Pa. NES-100 Nanotechnology for delivery of metabolically labile intranasal peptide Acute and chronic pain Completed a pre-IND application meeting with FDA

Notes

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

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