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Home » Pipeline

Pipeline

May 4, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Inovio INO-4800 vaccine COVID-19 completion of patient enrollment in phase 1 trial
BioNTech

Pfizer
BNT162 vaccine COVID-19 completion of patient dosing in first cohort of phase 1/2 trial
Algernon Pharmaceuticals NP-120 (Ifenprodil) COVID-19 patients with severe pneumonia approval from the Ministry of Food and Drug Safety in South Korea for a phase 2 trial
ORYZON Genomics vafidemstat prevent progression to Acute Respiratory Distress Syndrome in patients with severe COVID-19 approval from the Spanish Agency for Medicines and Health Products for a phase 2 trial
Innate Pharma IPH5401 (avdoralimab) COVID-19 patients with severe pneumonia first patient dosed in phase 2 trial
Moderna mRNA-1273 vaccine COVID-19 second round of dosing in phase 2 trial
Chimerix dociparstat sodium (DSTAT) COVID-19 patients with acute lung injury initiation of a phase 2/3 trial
Mesoblast allogeneic mesenchymal stem cell therapy remestemcel-L moderate/severe acute respiratory distress syndrome due to COVID-19 initiation of a phase 2/3 trial
CTI BioPharma pacritinib hospitalized patients with severe COVID-19 initiation of phase 3 trial
Romark Labs NT-300 (nitazoxanide extended-release tablets) prevention of COVID-19 in elderly residents of long-term care facilities and healthcare workers initiation of two phase 3 trials
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG test COVID-19 Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
Adverum Biotechnologies ADVM-022 wet age-related macular degeneration dosing of first patient in cohort 4 of phase 1 trial
BioXcel Therapeutics BXCL701 in combination with pembrolizumab (Keytruda) treatment of emergent neuroendocrine prostate cancer initiation of the phase 2 portion of phase 1b/2 trial
RhoVac AB RV001 advanced prostate cancer first patient dosed in phase 2b trial
Windtree Therapeutics AEROSURF premature infants with respiratory distress syndrome enrollment of first patient in phase 2b bridging trial
BioEclipse Therapeutics CRX100 therapy-refractory solid tumors IND approved by the FDA
RemeGen RC48 (disitamab vedotin) HER2 positive metastatic or unresectable urothelial cancer IND approved by the FDA
Shanghai Green Valley Pharmaceuticals GV-971 Alzheimer's disease IND approved by the FDA
Zentalis Pharmaceuticals ZN-d5 hematologic malignancies IND approved by the FDA
Neon Therapeutics neoantigen-targeted T cell therapy (NEO-PTC-01) patients with metastatic melanoma who are not responsive to checkpoint inhibitors clinical trial authorization granted by the Dutch Healthcare Authority
Takeda Pharmaceuticals mobocertinib (TAK-788) patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy Breakthrough Therapy designation granted by the FDA
AmideBio, LLC ABG-023 congenital hyperinsulinism Orphan Drug designation granted by the FDA
Zambon Liposomal Cyclosporine A for inhalation (L CsA i) Bronchiolitis Obliterans Syndrome Fast Track designation granted by the FDA
Merck Keytruda all adult indications, including monotherapy and combination therapy approved by the FDA as a new dosage of 400 mg every six weeks
Neurocrine Biosciences Ongentys as add-on to levodopa/carbidopa patients with Parkinson's disease experiencing "off" episodes approved by the FDA
Sanofi MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine prevention of invasive meningococcal disease in persons 2 years of age and older approved by the FDA
GlaxoSmithKline Zejula (niraparib) maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status approved by the FDA for expanded indication

 

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