Company Product Description Indication Status
Aclaris Therapeutics Inc., of Wayne, Pa. ATI-1777 JAK 1/3 kinase inhibitor Atopic dermatitis IND application to treat moderate to severe disease submitted to FDA
Asieris Pharmaceuticals Co. Ltd., of Shanghai APL-1702 (Cevira) Hexaminolevulinate photodynamic drug-device therapy Cervical dysplasia China NMPA granted CTA for global phase III trial for nonsurgical treatment of high-grade disease
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Pancreatic cancer EU approved drug as monotherapy for maintenance treatment of adults with germline BRCA1/2 mutations and metastatic disease who did not progress after minimum of 16 weeks of platinum treatment within first-line chemotherapy regimen
Biogen Inc., of Cambridge, Mass., and Eisai Co. Ltd., of Tokyo Aducanumab Beta-amyloid antagonist Alzheimer's disease BLA submission to FDA completed; priority review requested
Concert Pharmaceuticals Inc., of Lexington, Mass. CTP-543 (deuterium-modified ruxolitinib analog) JAK 1/2 kinase inhibitor Alopecia areata FDA granted breakthrough therapy designation
Cormedix Inc., of Berkeley Heights, N.J. Defencath/neutrolin (catheter lock solution) Drug-device combination with antibacterial/antifungal solution Catheter-related bloodstream infections Submission of NDA to FDA completed for treatment of individuals with end-stage renal disease who receive hemodialysis via central venous catheter; priority review requested
Croma-Pharma GmbH, of Leobendorf, Austria LetibotulinumtoxinA  Botulinum toxin A stimulator Frown lines Drug file submitted to Germany's BfArM
Merck & Co. Inc., of Kenilworth, N.J., and Eisai Co. Ltd., of Tokyo Keytruda (pembrolizumab) + Lenvima (lenvatinib) PD-1 inhibitor + FGF1/2/3/4 receptor antagonist Hepatocellular carcinoma FDA issued CRL for application seeking accelerated approval of drug combination to treat first-line unresectable disease, citing no meaningful advantage over available therapies; companies plan to continue advancing combo through phase III program
Talaris Therapeutics Inc., of Boston FCR-001 Allogeneic cell therapy Scleroderma FDA cleared IND to initiate phase I/IIa study in diffuse systemic sclerosis

Notes

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

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