Company Product Description Indication Status
Arch Biopartners Inc., of Toronto Metablok LSALT peptide COVID-19 Filed applications to Turkish Ministry of Health and local Ethics Committee to recruit patients in phase II trial
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) Antibody targeting PD-L1 Small-cell lung cancer European Union approved for use in first-line treatment in adults with extensive-stage disease in combination with etoposide plus either carboplatin or cisplatin
Athenex Inc., of Buffalo, N.Y. Oral paclitaxel and encequidar Oral taxane with P-gp inhibitor to increase absorption Metastatic breast cancer FDA accepted for filing the NDA, granting priority review; PDUFA date set for Feb. 28, 2021
Bristol Myers Squibb Co., of New York Onureg (azacitidine 300-mg tablets; CC-486) Oral hypomethylating agent Acute myeloid leukemia Approved by FDA for use in continued treatment of adult patients who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy
Glaxosmithkline plc, of London Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder for oral inhalation) Muscarinic receptor antagonist; beta 2 adrenoceptor agonist Chronic obstructive pulmonary disease FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 14-1 against supplemental NDA seeking a labeling change to include reduction in all-cause mortality in COPD; panel agreed efficacy data submitted did not support that claim
Inmune Bio Inc., of La Jolla, Calif. Quellor Selective soluble TNF inhibitor Immune-mediated complications in COVID-19 FDA accepted the IND for a phase II trial
Mirum Pharmaceuticals Inc., of Foster City, Calif. Maralixibat Apical sodium dependent bile acid transporter inhibitor  Cholestatic pruritus in patients with Alagille syndrome Submitted first portion of its rolling NDA to the FDA
Nkmax America Inc., of Santa Ana, Calif. SNK-01 Autologous natural killer cell immunotherapy Refractory solid tumors FDA granted permission to amend the phase I study to add a fourth cohort testing up to 18 patients with SNK-O1 plus Keytruda (pembrolizumab, Merck & Co. Inc.) or Bavencio (avelumab, Merck KGaA/Pfizer Inc.)
Novo Nordisk A/S, of Bagsvaerd, Denmark Sogroya (somapacitan) Weekly human growth hormone therapy Growth hormone deficiency  Approved by FDA for use in adults
Plus Therapeutics Inc., of Austin, Texas Rhenium Nanoliposomes Nanoparticle radioisotope Recurrent glioblastoma FDA granted orphan designation
Vertex Pharmaceuticals Inc., of Boston Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) CFTR modulator/stimulator Cystic fibrosis  FDA accepted supplemental NDAs for the drugs to cover patients with additional rare CFTR mutations; applications would also allow certain patients eligible for Kalydeco to be eligible for Symdeko or Trikafta and certain patients eligible for Symdeko to be eligible for Trikafta; PDUFA action date is Dec. 30, 2020

Notes

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