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