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Home
» Drug & Device Pipeline News
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
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