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Drug & Device Pipeline News
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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