Company Product Description Indication Status
Bavarian Nordic A/S, of Copenhagen, and Janssen Vaccines & Prevention BV, a unit of New Brunswick, N.J.-based Johnson & Johnson Mvabea (MVA-BN filo) and Zabdeno (Ad26.ZEBOV) Modified vaccinia virus ankara- and adenovirus serotype 26-based vaccines Ebola virus infection prophylaxis European Commission granted marketing authorization for the 2-dose regimen
Blueprint Medicines Corp., of Cambridge, Mass. Pralsetinib RET inhibitor Advanced or metastatic RET mutant medullary thyroid cancer and RET fusion-positive thyroid cancers Filed NDA with the FDA
EMD Serono, a unit of Darmstadt, Germany-based Merck KGaA, and Pfizer Inc., of New York Bavencio (avelumab) Monoclonal antibody targeting PD-L1 Urothelial carcinoma  FDA approved the supplemental BLA for use in treating locally advanced or metastatic disease that has not progressed with first-line platinum-containing chemotherapy
Golden Biotechnology Corp., of Taipei, Taiwan Hocena (antroquinonol) Isoprenyl transferase inhibitor Mild to moderate pneumonia in COVID-19 patients FDA approved the IND for a phase II study
Isa Pharmaceuticals BV, Leiden, the Netherlands ISA-101b Immunotherapy targeting oncogenic E6 and E7 proteins of HPV16 Human papillomavirus type 16-positive cervical cancer FDA granted orphan drug designation
Medicinova Inc., of La Jolla, Calif. MN-166 (ibudilast) PDE4 and 10 inhibitor Prevention of acute respiratory distress syndrome in patients with COVID-19 FDA approved the IND for a phase II study with primary endpoints of the proportion of patients free of respiratory failure, change in clinical status measured by NIAID scale and plasma cytokine levels after 7 days of treatment
Mezzion Pharma Co. Ltd., of Seoul, South Korea Udenafil  PDE5 inhibitor Single ventricle heart disease after a Fontan operation Submitted an NDA to the FDA with a request for a priority review
Revive Therapeutics Ltd., of Toronto Bucillamine  Cysteine derivative with 2 thiol groups Mild to moderate COVID-19 Submitted IND to the FDA for an 800-patient phase III study scheduled to start in the third quarter of 2020
Rhythm Pharmaceuticals, Inc., of Boston  Setmelanotide Melanocortin-4 receptor agonist Pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity Submitted MAA to the EMA; FDA grated granted rare pediatric disease designation
Scpharmaceuticals Inc., of Burlington, Mass. Furoscix Furosemide solution formulated for use with a wearable subcutaneous injector Congestion in patients with heart failure Resubmitted the 505(b)(2) NDA to the FDA; addressed concerns raised in the June 2018 complete response letter
Sun Biopharma Inc., of Minneapolis SBP-101 Polyamine analogue First-line metastatic pancreatic ductal adenocarcinoma FDA granted fast track designation
TC Biopharm Ltd., of Glasgow, U.K. Gamma-delta T Immunotherapy targeting SARS-CoV-2-infected cells COVID-19 Submitted documents to U.K. regulators to start safety trials
Obseva SA, of Geneva, and Hangzhou Yuyuan Bioscience Technology Co. Ltd., of Hangzhou, China Nolasiban  Oxytocin receptor antagonist In vitro fertilization Submitted a pre-IND meeting request to the Center for Drug Evaluation at the Chinese National Medical Products Administration
Ultragenyx Pharmaceutical Inc., of Novato, Calif Dojolvi (triheptanoin) Odd-carbon medium-chain triglyceride consisting of three 7-carbon fatty acids on a glycerol backbone Molecularly confirmed long-chain fatty acid oxidation disorders FDA approved the marketing application
Y-mabs Therapeutics Inc., of New York Omburtamab  Monoclonal antibody targeting B7-H3 Central nervous system/leptomeningeal metastases from neuroblastoma Started rolling submission of the BLA to the FDA

Notes

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

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