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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

March 7, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Aquestive Therapeutics AQST-109 Severe allergic reactions IND approved by the FDA
RedCloud Bio H002 EGFR-positive nonsmall-cell lung cancer IND approved by the FDA
Sorrento Therapeutics STI-9199 (Covishield) COVID-19 IND approved by the FDA
Harbour BioMed HBM7008 Solid tumors Approval for a phase 1 trial granted by Australia’s regulatory authority
InnoCare Pharma Orelabrutinib Neuromyelitis optica spectrum disorder Approval for a phase 2 trial granted by China’s regulatory authority
Trials Initiated
ProJenX PRO-101 Amyotrophic lateral sclerosis Initiation of phase 1 trial
Oncocross OC514 Sarcopenia Initiation of phase 1 trial in Australia
Elpiscience ES104 Colorectal cancer Initiation of phase 1/2 trial in China
Genprex Reqorsa plus Tagrisso Nonsmall-cell lung cancer Initiation of phase 1/2 trial
Intellia Therapeutics NTLA-5001 Acute myeloid leukemia Initiation of phase 1/2 trial
Bold Therapeutics BOLD-100 Advanced gastrointestinal cancers Initiation of phase 2 portion of phase 1b/2 trial
Transcenta TST001 Biliary tract cancer Initiation of phase 2a trial in China
Xalud Therapeutics XT-150 Facet joint osteoarthritis pain Initiation of phase 2a trial
Actuate Therapeutics Elraglusib plus retifanlimab Advanced pancreatic cancer Initiation of phase 2 trial
Aramis Biosciences A197 Dry eye disease Initiation of phase 2 trial
CatalYm CTL-002 (visugromab) Solid tumors Initiation of phase 2 trial
Kazia Therapeutics Paxalisib Glioblastoma Initiation of phase 2 trial
Kintor Pharmaceutical KX-826 (pyrilutamide) Male androgenetic alopecia Initiation of phase 2 trial
Lynk Pharmaceuticals LNK01001 Atopic dermatitis Initiation of phase 2 trial
ALX Oncology

Eli Lilly
Evorpacept plus ramucirumab HER2-positive gastric cancer or gastroesophageal junction cancer Initiation of phase 2/3 trial
Seelos Therapeutics SLS-005 Amyotrophic lateral sclerosis Initiation of phase 2/3 trial
Lyra Therapeutics LYR-210 Chronic rhinosinusitis Initiation of phase 3 trial
NewAmsterdam Pharma Obicetrapib Atherosclerotic cardiovascular disease Initiation of phase 3 trial
Approvals
Boehringer Ingelheim Jardiance (empagliflozin) All types of heart failure Approved by the FDA for expanded indication
CTI BioPharma Vonjo (pacritinib) Myelofibrosis and thrombocytopenia Accelerated approval granted by the FDA
Legend Biotech Carvykti (ciltacabtagene autoleucel) Relapsed or refractory multiple myeloma Approved by the FDA
Kaléo Naloxone auto-injector Exposure to ultrapotent weaponized opioids Approved by the FDA
Medicago

GlaxoSmithKline
Covifenz COVID-19 vaccine COVID-19 Approved in Canada

 

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