|Affiris AG, of Vienna||Affitope PD-01||Synuclein alpha inhibitor||Parkinson's disease||FDA provided feedback on pre-IND submission for planned phase II trial in early stage disease; based on agency's guidance, trial initiation in U.S. and Europe expected in second half of 2020|
|Corium International Inc., of Menlo Park, Calif.||Adlarity (donepezil transdermal patch)||Acetylcholinesterase inhibitor||Alzheimer's disease||FDA accepted NDA filing for treatment of individuals with mild, moderate and severe disease, setting PDUFA date of July 30, 2020|
|Genentech, unit of Roche Holding AG, of Basel, Switzerland||Tecentriq (atezolizumab)||PD-L1 inhibitor||Hepatocellular carcinoma||sBLA submitted to FDA for study drug in combination with Avastin (bevacizumab, Roche) to treat unresectable disease in those with no prior systemic therapy; agency reviewing under Real-Time Oncology Review pilot program|
|Merck & Co. Inc., of Kenilworth, N.J.||Dificid (fidaxomicin)||Macrolide antibacterial medicine||Clostridioides difficile infection||FDA approved NDA for oral suspension and sNDA for tablet formulation to treat C. diff-associated diarrhea in children 6 months and older|
|Neoimmunetech Inc., of Rockville, Md.||Hyleukin-7 (NT-I7)||IL-7 receptor agonist||Solid tumors||FDA cleared IND application for phase Ib/IIa basket study in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) to treat relapsed/refractory advanced disease|
|Pharmacyte Biotech Inc., of New York||Cell-in-a-Box||CYP2B1 gene modulator||Pancreatic cancer||Product that will be used in upcoming phase IIb trial in locally advanced, inoperable disease passed each of FDA's required release tests for safety and functionality|
For more information about individual companies and/or products, see Cortellis.