Pipeline

October 26, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Edesa Biotech EB05 hospitalized adults with COVID-19 who have or are at risk of developing acute respiratory distress syndrome IND approved by the FDA
Reven Pharmaceuticals Rejuveinix hospitalized COVID-19 patients at high risk of progressing and developing acute respiratory distress syndrome or who are in hypoxemic respiratory failure IND approved by the FDA
ImmunityBio

NantKwest		 hAd5-COVID-19 COVID-19 vaccine first patient dosed in phase 1 trial
Abpro ABP 300 monoclonal antibody therapy against COVID-19 patient dosing complete in phase 1 trial
Beyond Air LungFit system (inhaled, high-dose nitric oxide) adults hospitalized with acute viral pneumonia, including SARS-CoV-2 approval to commence phase 2 trial in Israel
Arch Biosciences LSALT peptide (Metablok) prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19 first patient dosed in phase 2 trial
Enlivex Therapeutics Allocetra severe and critical COVID-19 patients first patients dosed in phase 2 trial
Dr. Reddy’s Labs Sputnik V COVID-19 vaccine COVID-19 approval received from the Drug Controller General of India to conduct an adaptive phase 2/3 trial
Centogene CentoSure SARS-CoV-2 RT-PCR test Emergency Use Authorization (EUA) granted by the FDA
Eurofins U.S. Clinical Diagnostics at-home COVID-19 nasal PCR test COVID-19 testing EUA granted by the FDA
Orasure Technologies DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device COVID-19 testing EUA granted by the FDA
Spectrum Solutions SDNA-1000 saliva collection device detecting COVID-19 infections EUA granted by the FDA
Other Trials and Actions
Mereo Biotech etigilimab a defined series of tumor types, including biomarker-enriched and rare tumor cohort IND approved by FDA
Adial Pharmacueticals AD04 alcohol use disorder IND reactivated by FDA
Adicet Bio ADI-001 nonHodgkin’s lymphoma IND approved by FDA
Intellia Therapeutics NTLA-2001 hereditary transthyretin amyloidosis with polyneuropathy CTA approved by the UK Medicines and Healthcare products Regulatory Agency
Daiichi Sankyo DS-1055 patients with advanced or metastatic solid tumors who have progressed on standard treatment including checkpoint inhibitors first patient dosed in phase 1 trial
Galera Therapeutics GC4711 in combination with stereotactic body radiation therapy non-small-cell lung cancer first patient dosed in phase 1/2 trial
Onexo AsiDNA patients with acquired resistance to niraparib for second-line maintenance treatment of relapsed ovarian cancer first patient treated in phase 1b/2 trial
Aslan Pharmaceuticals ASLAN004 moderate to severe atopic dermatitis initiation of third dose cohort of phase 2 trial
Oxeia Biopharmaceuticals OXE103 patients within 28 days of injury who are highly symptomatic of concussion initiation of phase 2 trial
Trevi Therapeutics Haduvio (nalbuphine ER) chronic cough in patients with idiopathic pulmonary fibrosis patient screening resumed in phase 2 trial
Imara IMR-687 beta-thalassemia first patient dosed in phase 2b trial
Cyclo Therapeutics Trappsol Cyclo (Hydroxypropyl-?-cyclodextrin) Niemann-Pick Disease Type C1 initiation of phase 3 trial
Evofem Biosciences EVO100 prevention of urogenital chlamydia and gonorrhea in women first patient enrolled in phase 3 trial
Mycovia Pharmaceuticals oteseconazole (VT-1161) recurrent vulvovaginal candidiasis last patient visit complete in phase 3 trial
Versantis AG VS-01 urea cycle disorders Rare Pediatric Disease designation granted by the FDA
Genentech Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy approved by the FDA
Embody Tapestry Biointegrative Implant tendon and ligament repair approved by the FDA

 

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