Company Product Description Indication Status
Adamis Pharmaceuticals Corp., of San Diego Zimhi (naloxone HCI) Opioid receptor antagonist Opioid overdose NDA resubmitted to FDA following CRL
Akebia Therapeutics Inc., of Cambridge, Mass. Riona (ferric citrate) Iron-based phosphate binder Iron deficiency anemia Collaboration partner Japan Tobacco Inc. filed sNDA with PMDA to add indication in Japan
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (fam-trastuzumab deruxtecan-nxki) ERBB2 tyrosine kinase receptor inhibitor; topoisomerase I inhibitor Non-small-cell lung cancer FDA granted breakthrough therapy designation to treat metastatic disease in people whose tumors have HER2 mutation and disease progressed on or after platinum-based therapy
Astrazeneca plc, of Cambridge, U.K. Bevespi Aerosphere (glycopyrronium/formoterol fumarate) Beta 2 adrenoceptor agonist; muscarinic receptor antagonist Chronic obstructive pulmonary disease China NMPA approved as maintenance treatment, including chronic bronchitis and/or emphysema
Biosig Technologies Inc., of Westport, Conn. Merimepodib Inosine monophosphate dehydrogenase inhibitor COVID-19 infection FDA cleared IND application from subsidiary Viralclear Pharmaceuticals Inc. for phase II study in adults hospitalized with infection who require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) + Yervoy (ipilimumab) PD-1 inhibitor; CTLA4 inhibitor Metastatic non-small-cell lung cancer FDA approved combination as first-line treatment of adults whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic aberrations
Carsgen Therapeutics Co. Ltd., of Shanghai CAR-CLD18 T-cell therapy Claudin 18 modulator Advanced gastric or pancreatic cancer FDA cleared IND for open-label phase Ib trial expected to begin in third quarter of 2020
Cyclo Therapeutics Inc., of Gainesville, Fla. Trappsol Cyclo Cholesterol binding agent Niemann-Pick disease type C1 EMA provided final advice letter with positive feedback on proposed pivotal trial, including feedback from Committee for Orphan Medicinal Products that proposed development plan is sufficient to demonstrate benefit
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist COVID-19 infection Company plans to submit protocol to FDA for factorial design trial to compare effectiveness of leronlimab vs. and in combination with remdesivir (Veklury, Gilead Sciences Inc.)
Genentech Inc., of South San Francisco, a member of the Roche Group Tecentriq (atezolizumab) PD-L1 inhibitor Metastatic non-small-cell lung cancer Approved by FDA for use in treating adults whose tumors have high PD-L1 expression, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
Lidds AB, of Uppsala, Sweden
Liproca Depot 
Androgen receptor antagonist Prostate cancer Swedish MPA provided positive response on proposed design of phase III study in individuals with localized disease, within intermediate risk group; primary endpoint is time to disease progression, prompting radical treatment, over 24 months for study drug vs. active surveillance
Nantkwest Inc., of El Segundo, Calif. BM-Allo.MSC Allogeneic mesenchymal stem cell therapy COVID-19-related acute respiratory distress syndrome FDA cleared IND application for phase Ib study of therapy vs. current supportive care in individuals with severe disease who require ventilator support
Sellas Life Sciences Group Inc., of New York Galinpepimut-S Wilms tumor protein modulator Acute myeloid leukemia Independent data monitoring committee formed to monitor pivotal phase III Regal trial
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel Austedo (deutetrabenazine) Synaptic vesicular amine transporter inhibitor Huntington's chorea; tardive dyskinesia China NMPA approved drug following priority review
Vistagen Therapeutics Inc., of South San Francisco PH-94B CNS neuroactive nasal spray COVID-19-related anxiety Protocol submitted to FDA through Coronavirus Treatment Acceleration Program for phase IIa study

Notes

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

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