Pipeline

May 11, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Organicell Regenerative Medicine Organicell Flow moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection IND approved by the FDA
Global Institute of Stem Cell Therapy and Research (GIOSTAR) mesenchymal stem cells Covid-19 expanded access for compassionate use granted by the FDA
Eiger Biopharmaceuticals peginterferon lambda patients with mild COVID-19 first patient treated in phase 2 trial
Pulmotect PUL-042 prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease approval for two phase 2 trials granted by the FDA
Athersys MultiStem cell therapy COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS) enrollment of first patients in phase 2/3 trial
Mesoblast remestemcel-L COVID-19-infected patients with moderate to severe ARDS on ventilator support first patients dosed in phase 2/3 trial
Aridis Pharmaceuticals AR-301 S. aureus induced pneumonia in COVID-19 patients on mechanical ventilators enrollment of first patient in phase 3 trial
Gilead remdesivir COVID-19 Emergency Use Authorization (EUA) granted by the FDA
EUROIMMUN (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test detection of COVID-19 antibodies EUA granted by the FDA
Rheonix Rheonix COVID-19 MDx Assay detection of SARS-CoV-2 EUA granted by the FDA
Roche Elecsys Anti-SARS-CoV-2 antibody test detection of COVID-19 antibodies approved by the FDA
Other Trials and Actions
Bicycle Therapeutics BT5528 in combination with nivolumab advanced solid tumors in indications associated with EphA2 expression first patient dosed in phase 1 trial
Scholar Rock SRK-181 locally advanced or metastatic solid tumors first patients dosed in phase 1 trial
Viriom VM1500A HIV-infected patients initiation of phase 2a trial
Kubota Vision emixustat hydrochloride macular atrophy secondary to Stargardt disease completion of patient enrollment in phase 3 trial
Spero Therapeutics tebipenem HBr complicated urinary tract infection and acute pyelonephritis completion of patient enrollment in phase 3 trial
Alume Biosciences ALM-488 peptide-dye conjugate for fluorescence highlighting of nerves during head and neck surgery IND approved by the FDA
Green Valley Pharmaceutical GV-971 Alzheimer’s disease IND approved by the FDA
Lipocine LPCN 1148 liver cirrhosis in adult male cirrhotic patients IND approved by the FDA
Nanobiotix NBTXR3 patients with locally advanced or borderline resectable cases of pancreatic ductal adenocarcinoma IND approved by the FDA
GeneTx Biotherapeutics

Ultragenyx Pharmaceuticals		 GTX-102 Angelman syndrome Fast Track designation granted by the FDA
Ascentage Pharma HQP1351 chronic myeloid leukemia Orphan Drug designation granted by the FDA
Seelos Therapeutics SLS-005 Sanfilippo syndrome Orphan Drug designation granted by the FDA
AstraZeneca Farxiga (dapagliflozin) adults with New York Heart Association's functional class II-IV heart failure with reduced ejection fraction approved by the FDA for new indication
Galderma Research Restylane Kysse lip augmentation and the correction of wrinkles around upper lips in adults over the age of 21 approved by the FDA
Halozyme Therapeutics

Janssen Biotech		 DARZALEX FASPRO (daratumumab hyaluronidase human- fihj) multiple myeloma approved by the FDA
Novartis Tabrecta (capmatinib) NSCLC tumors that have an abnormal mesenchymal-epithelial transition gene that leads to MET exon 14 skipping approved by the FDA
Tolmar Pharmaceuticals FENSOLVI (leuprolide acetate) pediatric patients two years of age and older with central precocious puberty approved by the FDA

 

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