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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

April 4, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
HLT Medical HLT Meridian TAVR Valve System Aortic disease Approval for two clinical studies granted by the FDA
Pipeline Therapeutics PIPE-307 Relapsing-remitting multiple sclerosis IND approved by the FDA
ReAlta Life Sciences RLS-0071 Infants with hypoxic-ischemic encephalopathy IND approved by the FDA
Sorrento Therapeutics Abivertinib Hospitalized patients with severe pneumonia due to COVID-19 Approval for a phase 3 trial granted by the FDA
Antengene ATG-016 High-risk myelodysplastic syndromes IND approved by China’s regulatory authorities
InnoCare Pharma ICP-488 Autoimmune diseases IND approved by China’s regulatory authorities
JW Therapeutics Carteyva (relmacabtagene autoleucel injection) Large B-cell lymphoma IND approved by China’s regulatory authorities
Trials Initiated
Accutar Biotechnology AC0176 Metastatic castration-resistant prostate cancer Initiation of phase 1 trial
Anixa Biosciences CER-T therapy Ovarian cancer Initiation of phase 1 trial
CStone Pharmaceuticals CS5001 B-cell lymphomas and solid tumors Initiation of phase 1 trial
CureVac

GlaxoSmithKline
CV2CoV COVID-19 vaccine COVID-19 Initiation of phase 1 trial
HDT Bio HDT-301 COVID-19 vaccine COVID-19 Initiation of phase 1 trial
Innovent Biologics IBI389 Advanced solid tumors Initiation of phase 1a/1b trial
Prothena PRX012 Alzheimer’s disease Initiation of phase 1 trial
Airway Therapeutics AT-100 Preterm infants at risk for bronchopulmonary dysplasia Initiation of phase 1b trial
Tiziana Life Sciences Foralumab oral capsules Crohn's disease Initiation of phase 1b trial
Clarity Pharmaceuticals 64Cu SAR-bisPSMA Prostate cancer Initiation of phase 1/2 trial
Genprex Reqorsa Immunogene Therapy plus Keytruda Nonsmall-cell lung cancer Initiation of phase 1/2 trial
Ribon Therapeutics RBN-2397 plus Keytruda Squamous-cell carcinoma of the lung Initiation of phase 1b/2 trial
Sangamo Therapeutics TX200 Kidney transplant Initiation of phase 1/2 trial
Sumitomo Dainippon Pharma Oncology DSP-5336 Relapsed or refractory acute myeloid leukemia or acute lymphocytic leukemia Initiation of phase 1/2 trial
Acer Therapeutics ACER-801 Vasomotor symptoms associated with menopause Initiation of phase 2a trial
Morphic Therapeutic MORF-057 Moderate-to-severe ulcerative colitis Initiation of phase 2a trial
PTC Therapeutics PTC518 Huntington's disease Initiation of phase 2 trial
Prometheus Bioscience PRA023 Systemic sclerosis-associated interstitial lung disease Initiation of phase 2 trial
Taysha Gene Therapies TSHA-102 Rett syndrome Initiation of phase 1/2 trial in Canada
Aristea Therapeutics RIST4721 Palmoplantar pustulosis Initiation of phase 2b trial
Angiocrine Bioscience AB-205 Lymphoma patients undergoing autologous hematopoietic cell transplantation Initiation of phase 3 trial
GE Healthcare PET radiopharmaceutical Parkinsonian syndromes Initiation of phase 3 trial
MaaT Pharma MaaT013 Acute graft-vs.-host disease with gastrointestinal involvement Initiation of phase 3 trial
Vaxxinity UB-612 COVID-19 booster COVID-19 Initiation of phase 3 trial
Approvals
Antares Pharma Tlando (testosterone undecanoate) Hypogonadism in adult males Approved by the FDA
Janssen Cabenuva (cabotegravir and rilpivirine) HIV-1 Approved by the FDA for expanded indication
Moderna mRNA-1273 COVID-19 vaccine COVID-19 Emergency Use Authorization granted by the FDA for a second booster
Novo Nordisk Ozempic (semaglutide) Type 2 diabetes Approved by the FDA for new dose formulation
UCB Fintepla (fenfluramine) Lennox-Gastaut syndrome Approved by the FDA for new indication
STAAR Surgical EVO/EVO+ Visian Implantable Collamer Lens Myopia and myopia with astigmatism Approved by the FDA
Gilead Jyseleca (filgotinib) Ulcerative colitis Approved in Japan
Neurocrine Biosciences

Mitsubishi Tanabe Pharma
Dysval (valbenazine) Tardive dyskinesia Approved in Japan
Sanofi Xenpozyme (olipudase alfa) Acid sphingomyelinase deficiency Approved in Japan

 

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