Company Product Description Indication Status
Anpac Bio-Medical Science Co. Ltd., of Shanghai Class III lung cancer auxiliary diagnosis device  Cancer differentiation analysis technology Lung cancer China's NMPA authorized registration testing at designated medical device lab, to be followed by trial in at least 2 qualified institutions, each expected to enroll at least 300 participants to include control and confirmed lung cancer groups
Astrazeneca plc, of Cambridge, U.K. AZD-1222 (SARS-CoV-2 vaccine) COVID-19 spike glycoprotein modulator COVID-19 infection Swissmedic's human medicines expert committee concluded interim data submitted for assessment were not sufficient to permit authorization, requesting efficacy data from ongoing phase III trial in North and South America
Catapult Therapeutics BV, of Lelystad, the Netherlands CAP-100 Humanized anti-CCR7 antibody Chronic lymphocytic leukemia FDA cleared IND for phase I trial in people with relapsed or refractory disease; study expected to begin in second quarter of 2021
Elevar Therapeutics Inc., of Salt Lake City Rivoceranib mesylate (apatinib) Protein TKI; VEGF-2 receptor antagonist Adenoid cystic carcinoma FDA granted orphan drug designation
Ellodi Pharmaceuticals Inc., of Lawrenceville, N.J. APT-1011 (fluticasone propionate oral disintegrating tablet) Trifluorinated corticosteroid Eosinophilic esophagitis FDA granted fast track designation
Ideaya Biosciences Inc., of South San Francisco IDE-397 MAT2A inhibitor Solid tumors FDA cleared IND for phase I study in people with methylthioadenosine phosphorylase deletion; trial expected to begin in first quarter of 2021
Janssen Pharmaceutical Cos., of Beerse, Belgium, unit of Johnson & Johnson Spravato (esketamine nasal spray) NMDA antagonist Major depressive disorder European Commission authorized expanded use, co-administered with oral antidepressant therapy, as acute short-term treatment for rapid symptom reduction in adults with moderate to severe episode
Passage Bio Inc., of Philadelphia PBKR-03 AAV-galactocerebrosidase based gene therapy Infantile Krabbe disease (globoid cell leukodystrophy) FDA cleared IND for phase I/II trial, expected to begin in first half of 2021
Russian Direct Investment Fund (RDIF), of Moscow Sputnik V COVID-19 spike glycoprotein modulator COVID-19 infection  Myanmar government granted emergency use authorization of vaccine
Sinovac Biotech Ltd., of Beijing Coronavac Adjuvant inactivated SARS-CoV-2 vaccine COVID-19 infection China's NMPA granted conditional marketing authorization for people 18 and older
Supernus Pharmaceuticals Inc., of Rockville, Md. SPN-812 (viloxazine hydrochloride, extended release) Selective norepinephrine reuptake inhibitor Attention deficit hyperactivity disorder NDA resubmitted to FDA to address issues with in-house laboratory that conducted analytical testing, cited in November 2020 CRL
Viiv Healthcare Ltd., of London Rukobia (fostemsavir tromethamine) HIV gp120 protein inhibitor HIV-1 infection European Commission granted MAA in combination with other antiretroviral therapies to treat adults with multidrug-resistant infection

Notes

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