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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

September 27, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Accutar Biotechnology AC0682 Estrogen receptor-positive breast cancers IND approved by the FDA
Biomea Fusion BMF-219 Relapsed or refractory acute leukemia IND approved by the FDA
T-Cure Biosciences KK-LC-1 TCR therapy Multiple solid tumors IND approved by the FDA
AB Science AB8939 Relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome Approval for a phase 1/2 trial granted by Canada’s regulatory authority
Ampio Pharmaceuticals AP-019 Respiratory distress due to COVID-19 Approval for a phase 2 trial granted by India’s regulatory authority
Arcutis ARCT-154 SARS-CoV-2 delta variant Approval for a phase 2/3a trial granted by Vietnam’s regulatory authority
CytoDyn leronlimab Hospitalized COVID-19 patients in critical condition Approval for a phase 3 trial granted by Brazil’s regulatory authority
Inovio INO-4800 COVID-19 vaccine Approval for the phase 3 portion of a phase 2/3 trial granted by Mexico’s regulatory authority
OpSens SavvyWire Transcatheter aortic valve replacement Approval for a trial approved by Canada’s regulatory authority
Trials Initiated
Odyssey Group International PRV-002 Concussion Initiation of phase 1 trial
Monopar Therapeutics camsirubicin Advanced soft tissue sarcoma Initiation of phase 1b trial
Daré Bioscience DARE-VVA1 Moderate-to-severe vulvar and vaginal atrophy Initiation of phase 1/2 trial
Bayer Kerendia (finerenone) Nondiabetic chronic kidney disease Initiation of phase 3 trial
HutchMed surufatinib plus toripalimab Advanced neuroendocrine carcinoma Initiation of phase 3 trial
Tarsier Pharma TRS01 eye drops Active noninfectious anterior uveitis Initiation of phase 3 trial
Vicore Pharma C21 COVID-19 Initiation of phase 3 trial
Zenith Epigenetics

Newsoara BioPharma
ZEN-3694 plus enzalutamide Metastatic castration-resistant prostate cancer Initiation of phase 3 trial
Approvals
Junshi Biosciences etesevimab and bamlanivimab Postexposure prophylaxis against COVID-19 in certain individuals age 12 years and older Emergency Use Authorization expanded by the FDA
BeiGene Brukinsa (zanubrutinib) Adults with relapsed or refractory marginal-zone lymphoma Approved by the FDA for expanded indication
Exelixis Cabometyx (cabozantinib) Treatment of patients age 12 years and older with radioactive iodine-refractory differentiated thyroid cancer Approved by the FDA for expanded indication
Incyte Jakafi (ruxolitinib) Chronic graft vs. host disease after failure of one or two lines of systemic therapy in patients older than 12 years Approved by the FDA for new indication
Incyte Opzelura (ruxolitinib) cream Atopic dermatitis in patients age 12 years and older Approved by the FDA
Mayne Pharma Lexette (halobetasol propionate) foam, 0.05% Plaque psoriasis in patients age 12 years and older Approved by the FDA
Pfizer-BioNTech Pfizer-BioNTech COVID-19 vaccine booster Prevention of COVID-19 in people older than 65 years, people under 65 with existing comorbidities and front-line healthcare workers Approved by the FDA for expanded indication
Seagen

Genmab
Tivdak (tisotumab vedotin-tftv) Recurrent or metastatic cervical cancer Accelerated approval granted by the FDA
Abbott Labs Portico with FlexNav transcatheter aortic valve replacement system High-risk patients with symptomatic, severe aortic stenosis Approved by the FDA

 

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