Company Product Description Indication Status Date
Apogenix AG, of Heidelberg, Germany Asunercept Extracellular domain of CD95 receptor and Fc domain of IgG1 antibody fusion protein  Severe COVID-19 Received regulatory approval to start the 400-patient phase II Asunctis study in Russia; study will compare 3 doses of drug plus standard of care (SOC) to SOC alone; plans to expand into other European countries, including Spain 7/28/20
Ascletis Pharma Inc., of Hangzhou, China RDV/DNV regimen Ravidasvir and danoprevir  Hepatitis C infection China's National Medical Products Administration approved the treatment 7/31/20
Aytu Bioscience Inc., of Englewood, Colo. Zolpimist (zolpidem tartrate oral spray) Benzodiazepine receptor agonist Sleep aid Sublicensee Suda Pharmaceuticals Ltd. received marketing approval from Australia’s Therapeutic Good Administration  7/30/20
Calidi Biotherapeutics Inc., of San Diego Adipose-derived mesenchymal stem cells Stem cell therapy COVID-19 infection FDA cleared IND for phase I trial by partner Personalized Stem Cells Inc. in 20 hospitalized patients 8/3/20
Celltrion Group, of Incheon, South Korea CT-P59 Antiviral antibody COVID-19 U.K.’s Medicines and Healthcare products Regulatory Agency approved clinical trial authorization for phase I study in patients with mild symptoms of SARS-CoV-2 infection 7/30/20
Direct Biologics LLC, of Austin, Texas Exoflo Bone marrow-derived extracellular vesicle and exosome product COVID-19-associated acute respiratory distress syndrome FDA cleared IND for phase II Exit COVID-19 trial; patient enrollment expected to start in next 30 days 7/30/20
Edesa Biotech Inc., of Toronto EB-05 TLR4-targeting monoclonal antibody COVID-19 Filed IND with FDA for a phase II/III study in hospitalized patients 7/30/20
Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J. Lenvima (lenvatinib mesylate) Multiple receptor tyrosine kinase inhibitor Unresectable thymic carcinoma Submitted a marketing application in Japan 7/31/20
Foresee Pharmaceuticals Co. Ltd., of Taipei, Taiwan Camcevi (FP-001) 6-month depot formulation of leuprolide mesylate Advanced prostate cancer Submitted NDA to FDA under 505(b)(2) pathway, seeking approval as palliative treatment 7/28/20
Hutchison China Meditech Ltd., of Hong Kong Savolitinib Small-molecule MET inhibitor Non-small-cell lung cancer China’s NMPA granted priority review status to the NDA seeking approval for use in treating NSCLC with MET exon 14 skipping mutations 7/28/20
Poxel SA, of Lyon, France, and Sumitomo Dainippon Pharma Ltd., of Osaka, Japan Imeglimin Tetrahydrotriazine compound Type 2 diabetes Sumitomo submitted Japanese NDA 7/30/20
Realta Life Sciences Inc., of Norfolk, Va. RLS-0071 Peptide designed to inhibit complement and anti-inflammatory immune responses Acute lung injury secondary to COVID-19 FDA accepted IND; phase I study in adults with pneumonia and early respiratory failure set to start in the third quarter of 2020 7/28/20
Relief Therapeutics Holding AG, of Geneva, and Neurorx Inc., of Radnor, Pa. RLF-100 (aviptadil)  VIP receptor agonist COVID-19-related respiratory failure FDA granted expanded access protocol to those ineligible for enrollment in clinical trial, including pregnant women, who exhausted approved therapies 7/29/20
Revive Therapeutics Ltd., of Toronto Bucillamine Cysteine derivative with 2 thiol groups Mild to moderate COVID-19 FDA approved it to proceed with randomized, double-blind, placebo-controlled confirmatory phase III trial protocol to evaluate safety and efficacy  7/31/20
Sound Pharmaceuticals Inc., of Seattle SPI-1005 (ebselen) Glutathione peroxidase stimulator COVID-19 Filed an IND application with the FDA to begin phase II studies 7/31/20
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Pevonedistat NEDD8-activating enzyme inhibitor Higher-risk myelodysplastic syndromes FDA granted breakthrough therapy designation 7/30/20
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel Ajovy (fremanezumab) CGRP receptor antagonist Migraine Licensee Otsuka Pharmaceutical Co. Ltd. submitted NDA for preventive treatment to Japan PMDA 7/29/20

Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

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

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