Drug & Device Pipeline News

September 13, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
GNT Pharma	nelonemdaz	Acute ischemic stroke	IND approved by South Korea’s regulatory authority for a phase 3 trial
Gannex Pharma/Ascletis Pharma	ASC42	Primary biliary cholangitis	Trial authorized by China’s regulatory authority
PharmAbcine	olinvacimab plus Keytruda	Metastatic triple-negative breast cancer	Phase 2 trial authorized by the Australian regulatory authority
Trials Initiated
Cortexyme	COR588	Periodontal disease and other P. gingivalis-related indications	Initiation of phase 1 trial
EdiGene	ET-01 (gene-editing hematopoietic stem cell therapy)	Transfusion-dependent ?-thalassemia	Initiation of phase 1 trial
Inversago Pharma	INV-202	Metabolic conditions	Initiation of phase 1 trial
Denali Therapeutics	DNL343	Amyotrophic lateral sclerosis	Initiation of phase 1b trial
Jasper Therapeutics	JSP191	GATA2-related myelodysplastic syndromes	Initiation of phase 1/2 trial
NovaVax	NVX-CoV2373 (COVID-19 vaccine) and NanoFlu (flu vaccine)	Combination vaccine for COVID-19 and seasonal influenza	Initiation of phase 1/2 trial
Hutchmed AstraZeneca	Orpathys (savolitinib) in combination with Tagrisso	Locally advanced or metastatic nonsmall-cell lung cancer with activating EGFR mutations and MET overexpression	Initiation of phase 3 trial
Inventiva	lanifibranor	Nonalcoholic steatohepatitis	Initiation of phase 3 trial
Approvals
Impel NeuroPharma	Trudhesa (dihydroergotamine mesylate) nasal spray	Acute treatment of migraine with or without aura in adults	Approved by the FDA
Intelivation Technologies	Advantage-C PEEK cervical interbody fusion device	For use during spinal surgery	Approved by the FDA
RenovoRX	RenovoCath delivery system	Targeted treatment of solid tumors	Approved by the FDA
Pfizer	Cibinqo (abrocitinib)	Patients 12 years and older with moderate-to-severe atopic dermatitis	Approved in the UK
Merck	Keytruda	First-line treatment for locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction	Approved in China
JW Therapeutics	relmacabtagene autoleucel injection	Relapsed or refractory large B-cell lymphoma	Approved in China
Sinovac	CoronaVac	Coronavirus vaccine	Approved for emergency use in Chile
Sumitomo Dainippon Pharma Nabriva Therapeutics	Xenleta (lefamulin)	Community-acquired pneumonia	Approved in Taiwan