Company Product Description Indication Status
Abbvie Inc., of North Chicago AGN-190584 (pilocarpine) Cholinergic muscarinic receptor agonist Presbyopia Submitted an NDA to the FDA
Abbvie Inc., of North Chicago Humira (adalimumab) Monoclonal antibody targeting tumor necrosis factor Moderately to severely active ulcerative colitis FDA approved use of the drug in pediatric patients 5 or older with ulcerative colitis
Aquestive Therapeutics Inc., of Warren, N.J. Libervant (diazepam) Buccal formulation of the benzodiazepine Seizure clusters FDA provided further guidance on the information and supporting analysis relating to revised weight-based dosing regimen required to address issues in the September 2020 complete response letter
Bluebird Bio Inc., of Cambridge, Mass. BB-1111 (betibeglogene autotemcel) Gene therapy expressing beta-globin Sickle cell disease FDA placed clinical holds on the phase I/II and phase III studies
Cansino Biologics Inc., of China Convidecia (Ad5-nCoV) Recombinant adenovirus-based vaccine COVID-19   NMPA granted conditional marketing authorization in mainland China
Exelixis Inc., of Alameda, Calif. Cabometyx (cabozantinib) Kinase inhibitor Differentiated thyroid cancer after progression on prior therapy and who radioactive iodine-refractory FDA granted breakthrough therapy designation
Gannex, a unit of Shanghai-based Ascletis Pharma Inc. ASC-41  Selective thyroid hormone receptor beta agonist  Nonalcoholic steatohepatitis  FDA cleared the IND
Retrotope Inc., of Los Altos, Calif. RT-001  Synthetic linoleic acid Infantile neuroaxonal dystrophy and Friedreich’s ataxia FDA granted rare pediatric disease designations for both indications; FDA granted fast track designation for Friedreich’s ataxia; EMA granted orphan drug designation for infantile neuroaxonal dystrophy
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Ministry of Health of the Republic of Guatemala granted emergency use authorization
Viiv Healthcare Ltd., of London, and Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Cabenuva (rilpivirine/cabotegravir) Antiviral HIV-1 infection Submitted a supplemental NDA to the FDA to include an option for administration every 2 months
Wuhan Institute of Biological Products Co. Ltd., part of China National Pharmaceutical Group Corp. (Sinopharm) COVID-19 vaccine Inactivated vaccine, produced in Vero cells, for intramuscular injection COVID-19 NMPA granted conditional marketing authorization in mainland China

Notes

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