Company Product Description Indication Status
ADC Therapeutics SA, of Lausanne, Switzerland Loncastuximab tesirine (ADCT-402) CD19-targeted antibody-drug conjugate Relapsed or refractory diffuse large B-cell lymphoma Submitted a BLA to the FDA
Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. Idecabtagene vicleucel (bb-2121) BCMA-directed CAR T-cell immunotherapy Relapsed and refractory multiple myeloma FDA accepted the BLA for priority review; PDUFA goal date of March 27, 2021
Crispr Therapeutics AG, of Zug, Switzerland, and Vertex Pharmaceuticals Inc., of Boston CTX-001  Autologous, gene-edited hematopoietic stem cell therapy  Sickle cell disease EMA granted Priority Medicines (PRIME) designation
Eli Lilly and Co., of Indianapolis Trulicity (dulaglutide) Glucagon-like peptide-1 analogue Diabetes mellitus Health Canada approved the new indication to reduce the risk of nonfatal stroke in adults with type 2 diabetes mellitus who have multiple cardiovascular risk factors or established cardiovascular disease, as an adjunct to diet, exercise and standard-of-care therapy
Emmetrope Ophthalmics LLC, of Menlo Park, Calif. EO-2002 Non-surgical, magnetic cell-based therapy  Corneal edema FDA accepted the IND application 
Genocea Biosciences Inc., of Cambridge, Mass. GEN-011 T-cell therapy Tumors FDA accepted the IND application
Knight Therapeutics Inc., of Montreal, and Therapeuticsmd Inc., of Boca Raton, Fla. Bijuva (estradiol + progesterone) Estradiol agonist; progesterone receptor agonist Moderate to severe vasomotor symptoms associated with menopause in women  Health Canada approved it 
Medeor Therapeutics Inc., of San Mateo, Calif. MDR-101 Uses the organ donor’s immune cells transfused into the organ recipient to create a mixed chimeric immune state in the recipient  Kidney transplant rejection FDA granted regenerative medicine advanced therapy designation
Mustang Bio Inc., of Worcester, Mass. MB-207 Lentiviral gene therapy X-linked severe combined immunodeficiency FDA granted orphan drug designation in previously transplanted patients
Nicox SA, of Sophia Antipolis, France, and Ocumension Therapeutics Ltd., of Shanghai Zerviate  Cetirizine ophthalmic solution Ocular itching associated with allergic conjunctivitis Received IND approval from China's Center for Drug Evaluation
Redhill Biopharma Ltd., of Tel Aviv, Israel Opaganib (Yeliva, ABC-294640) Sphingosine kinase-2 inhibitor Severe COVID-19 pneumonia The Brazilian Health Regulatory Agency (ANVISA) approved its ongoing global phase II/III study in hospitalized patients
UCB SA, of Brussels Bimekizumab  Interleukin-17F ligand inhibitor Moderate to severe plaque psoriasis FDA accepted the BLA and the EMA accepted the MAA

Notes

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

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