Pipeline

June 14, 2021

Company	Drug/Device	Medical Condition	Status
Alessa Therapeutics	Biolen system in conjunction with radiation therapy	localized prostate cancer	IND approved by the FDA
Cullinan Oncology	CLN-049	relapsed/refractory acute myeloid leukemia	IND approved by the FDA
Dynacure	DYN101	myotubular and centronuclear myopathies	IND approved by the FDA
Ascletis Pharma	ASC42	chronic hepatitis B	IND approved by the China National Medical Products Administration (NMPA)
Neurescue	Neurescue device	cardiac arrest treatment	Investigational Device Exemption (IDE) approved by the FDA
OraSure Technologies	InteliSwab	COVID-19 rapid antigen test	Emergency Use Authorization (EUA) granted by the FDA
Hoffman-La Roche	REGN-COV2 (casirivimab and imdevimab)	mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease	Interim Order authorization granted by Health Canada
Regeneron Pharmaceuticals	REGEN-COV (casirivimab and imdevimab)	mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease	EUA revised by the FDA for lower dose
Alexion Pharmaceuticals	Ultomiris (ravulizumab-cwvz)	paroxysmal nocturnal hemoglobinuria in children one month of age and older and adolescents	approved by the FDA for expanded patient population
Biogen Eisai	Aduhelm (aducanumab-avwa)	Alzheimer’s disease	approved by the FDA
Chimerix	Tembexa (brincidofovir)	smallpox vaccine	approved by the FDA
Liminal BioSciences/Prometic Biotherapeutics	Ryplazim (plasminogen, human-tvmh)	plasminogen deficiency type 1 (hypoplasminogenia)	approved by the FDA
Novo Nordisk	Wegovy (semaglutide) injection	chronic weight management in adults with obesity or who are overweight with at least one weight-related condition	approved by the FDA
Pfizer	Prevnar 20 (pneumococcal 20-valent conjugate vaccine)	prevention of invasive disease and pneumonia caused by the 20 streptococcus pneumoniae (pneumococcus) serotypes in adults	approved by the FDA
Vertex Pharmaceuticals	Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor)	children with cystic fibrosis ages six through 11 who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data	approved by the FDA for expanded patient population
Innovent Eli Lilly	Tyvyt (sintilimab injection) in combination with gemcitabine and platinum chemotherapy	first-line therapy for unresectable locally advanced or metastatic squamous nonsmall-cell lung cancer	approved by China’s NMPA for new indication
AngioDynamics	AlphaVac mechanical thrombectomy system	mechanical aspiration thrombectomy device for the nonsurgical removal of thrombi or emboli from the vasculature	approved by the FDA
Cardinal Health	Lymphoseek (technetium Tc 99m tilmanocept) injection	lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma or other types of solid tumors	approved by the FDA for new indication
Medtronic	SenSight directional lead system	deep-brain stimulation therapy	approved by the FDA
Neurescue	Neurescue device	temporary occlusion of large vessels, including patients requiring emergency control of hemorrhage	approved by the FDA
MiMedx Group	EPIFIX allografts	wound healing	approved by the Japanese Ministry of Health, Labor and Welfare