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Home » Pipeline

Pipeline

February 22, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Altimmune AdCOVID single-dose intranasal COVID-19 vaccine IND approved by the FDA
AIM ImmunoTech Ampligen intranasal therapy prophylaxis or treatment for COVID-19 and other respiratory viral diseases approval from the Ethics Committee in the Netherlands to begin phase 1 trial
Adagio Therapeutics ADG20 treatment and prevention of COVID-19 initiation of phase 1 trial
ImmunityBio

NantKwest
bivalent hAd5 T-cell COVID-19 vaccine COVID-19 vaccine approval to expand phase 1 trial to include subcutaneous, oral and sublingual boost
ReAlta Life Sciences RLS-0071 acute lung injury as a result of viral infection, including COVID-19, RSV and influenza first patient dosed in phase 1 trial
Diffusion Pharmaceuticals trans sodium crocetinate hospitalized COVID-19 patients with confirmed hypoxemia completion of phase 1b trial
Clene Nanomedicine CNM-ZnAg liquid solution acutely symptomatic, nonhospitalized COVID-19 patients initiation of phase 2 trial
RedHill Biopharma RHB-107 (upamostat) patients with symptomatic COVID-19 who do not require hospital care first patient dosed in phase 2/3 trial
AstraZeneca-Oxford COVID-19 vaccine COVID-19 Emergency Use Authorization (EUA) granted by the World Health Organization
Becton, Dickinson and Company BD SARS-CoV-2/Flu assay molecular diagnostic test for both SARS-CoV-2 and influenza A+B EUA granted by the FDA
Everlywell Everlywell COVID-19 Test Home Collection Kit detection of COVID-19 in asymptomatic individuals who have no suspected exposure to COVID-19 EUA granted by the FDA for direct-to-consumer distribution
GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit detection of COVID-19 neutralizing antibodies without the use of live virus EUA granted by the FDA
Luminostics Clip COVID Rapid Antigen Test detection of COVID-19 EUA granted by the FDA
Other Trials and Actions
Akan Biosciences StroMel osteoarthritis of the knee IND approved by the FDA
Lysogene LYS-GM101 GM1 gangliosidosis IND approved by the FDA
Signature Biologics Signature Cord Prime osteoarthritis of the knee IND approved by the FDA
Avacta Group AVA6000 pro-doxorubicin FAP-positive locally advanced or metastatic solid tumors clinical trial authorization granted by the UK Medicines and Healthcare products Regulatory Agency
Asklepios Bio

Selecta Bio
SEL-399 combined with ImmTOR mitigate unwanted immune responses associated with gene therapies initiation of phase 1 trial
Inhibikase Therapeutics IkT-148009 Parkinson’s disease first patients dosed in phase 1 trial
Ultimovacs Tetanus-Epitope Targeting (TET)-platform relapsed prostate cancer first patient dosed in phase 1 trial
vTv Therapeutics HPP737 psoriasis initiation of phase 1 trial
Salarius Pharma seclidemstat relapsed/refractory Ewing sarcoma completion of phase 1 portion of phase 1/2 trial
Kintara Therapeutics VAL-083 recurrent glioblastoma multiforme final patient enrolled in phase 2 trial
NeoImmuneTech NT-I7 (efineptakin alfa) in combinarion with Opdivo (nivolumab) patients with previously treated advanced or metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma first patient dosed in phase 2 trial
Pfizer elranatamab (PF-06863135) relapsed/refractory multiple myeloma first patient dosed in phase 2 trial
Valbiotis TOTUM-070 patients with untreated mild to moderate LDL-hypercholesterolemia approval from French regulatory authorities to initiate phase 2 trial
Moebius Medical MM-II pain due to knee osteoarthritis first patient dosed in phase 2b trial
Monopar Validive prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer first patient dosed in phase 2b/3 trial
Forge Biologics FBX-101 Krabbe disease Fast-Track, Orphan Drug and Rare Pediatric Disease designations granted by the FDA
Oryzon iadademstat acute myeloid leukemia Orphan Drug designation granted by the FDA
Targovax ONCOS-102 malignant pleural mesothelioma Fast-Track designation granted by the FDA
G1 Therapeutics Cosela (trilaciclib) decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive-stage small-cell lung cancer approved by the FDA
Novartis Entresto (sacubitril/valsartan) reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure approved by the FDA for expanded indication
Pfizer Panzyga (Immune Globulin Intravenous [Human] – ifas 10% Liquid Preparation) chronic inflammatory demyelinating polyneuropathy approved by the FDA for expanded indication
Regeneron Evkeeza (evinacumab-dgnb) adult and pediatric patients age 12 and older with homozygous familial hypercholesterolemia approved by the FDA
Additive Orthopaedics Patient Specific Talus Spacer patient-specific total talus replacement implant approved by the FDA
Delta International Service & Logistics Scrambler Therapy Technology ST-5A symptomatic relief of chronic opioid-resistant pain and chronic neuropathic and cancer pain approved by the FDA
Shockwave Medical Intravascular Lithotripsy severely calcified coronary artery disease approved by the FDA

 

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