|Adamis Pharmaceuticals Corp., of San Diego||Zimhi||High-dose naloxone injection||Opioid overdose||During type A meeting with FDA to discuss 2019 complete response letter, company obtained concurrence from agency on CMC information required for resubmission of NDA and discussed potential public health role of drug in opioid epidemic; company said it believes it can generate necessary information and resubmit NDA early in second quarter of 2020|
|Coimmune Inc., of Durham, N.C.||CMN-001 (formerly AGS-003)||Dendritic cell-based immunotherapy||Advanced metastatic renal cell carcinoma||FDA cleared IND for phase IIb trial|
|Eton Pharmaceuticals Inc., of Deer Park, Ill.||ET-105||Oral liquid formulation of lamotrigine||Epilepsy||FDA requested changes to dosage and administration section of prescribing information to simplify dosing; agency also requested company conduct a human factors validation study with the revised labeling to show intended users can prepare and administer the oral suspension safely and effectively|
|Genentech, of South San Francisco, a unit of Roche AG||Tecentriq (atezolizumab)||PD-L1-targeting antibody||Advanced nonsquamous and squamous non-small-cell lung cancer||FDA accepted supplemental BLA and granted priority review; application seeks approval for patients without EGFR or ALK mutations with high PD-L1 expression as determined by biomarker testing; PDUFA date is June 19, 2020|
|Merck & Co. Inc., of Kenilworth, N.J.||Keytruda (pembrolizumab)||PD-1-targeting antibody||Multiple cancer indications||FDA issued complete response letter regarding supplemental BLAs seeking to update dosing frequency to include a 400-mg dose infused over 30 minutes every 6 weeks|
|Retrotope Inc., of Los Altos, Calif.||RT-001||Chemically modified polyunsaturated fatty acid drug||Progressive supranuclear palsy||FDA granted orphan designation|
|Seattle Genetics Inc., of Bothell, Wash., and Astellas Pharma Inc., of Tokyo||Padcev (enfortumab vedotin-ejfv)||Antibody-drug conjugate directed against Nectin-4||Urothelial cancer||FDA granted breakthrough therapy designation for use in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with unresectable locally advanced or metastatic disease who are unable to receive cisplatin-based chemotherapy in the first-line setting|
For more information about individual companies and/or products, see Cortellis.