Company Product Description Indication Status
Altimmune Inc., of Gaithersburg, Md. Adcovid SARS-CoV-2 adenovirus vector vaccine COVID-19 infection FDA cleared IND for phase I trial in up to 180 healthy adults, expected to begin by end of February 2021
Amgen Inc., of Thousand Oaks, Calif. Sotorasib KRAS GTPase inhibitor Non-small-cell lung cancer FDA granted priority review to NDA to treat KRAS G12C-mutated locally advanced or metastatic disease, setting PDUFA date of 8/16/21
Beigene Ltd., of Beijing Brukinsa (xanubrutinib) BTK inhibitor Waldenström’s macroglobulinemia FDA accepted sNDA, setting PDUFA date of 10/18/21
Coherus Biosciences Inc., of Redwood City, Calif. CHS-1420 (adalimumab biosimilar) TNF alpha ligand inhibitor Psoriasis; psoriatic arthritis FDA accepted BLA for review under 351(k) pathway, setting BsUFA date in December 2021; potential U.S. launch would come on or after 7/1/23, per agreement with Humira manufacturer Abbvie Inc., of North Chicago
JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan JR-141 (pabinafusp alfa) Iduronate 2-sulfatase stimulator Mucopolysaccharidosis II (Hunter syndrome) FDA cleared IND to initiate global phase III trial and granted fast track designation
Johnson & Johnson, of New Brunswick, N.J. JNJ-78436735 (single-dose COVID-19 vaccine) SARS-CoV-2 recombinant adenoviral vector vaccine COVID-19 infection Conditional MAA submitted to EMA
Novartis AG, of Basel, Switzerland Entresto (sacubitril/valsartan) Neprilysin inhibitor/angiotensin receptor blocker  Heart failure FDA expanded label to include reducing risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure, particularly in those with left ventricular ejection fraction below normal
Pharmamar SA, of Madrid Aplidin (plitidepsin) Depsipeptide isolated from marine tunicate Aplidium albicans  COVID-19 infection U.K.'s MHRA approved initiation of phase III Neptuno study in people hospitalized with moderate infection
Russian Direct Investment Fund (RDIF), of Moscow  Sputnik V COVID19 spike glycoprotein modulator COVID-19 infection Republic of Uzbekistan approved vaccine
Ultragenyx Pharmaceutical Inc., of Novato, Calif. Dojolvi (triheptanoin) Facilitated glucose transporter-1 stimulator Long-chain fatty acid oxidation disorders Health Canada approved drug to treat adults and children
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin topical solution) Protein phosphatase 2A inhibitor Molluscum contagiosum infection FDA accepted resubmitted NDA, setting PDUFA date of 6/23/21

Notes

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