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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
TScan Therapeutics | T-Plex | Solid tumors | IND for a phase 1 trial approved by the FDA |
TScan Therapeutics | TSC-204-A0201 | Solid tumors | IND for a phase 1 trial approved by the FDA |
TScan Therapeutics | TSC-204-C0702 | Solid tumors | IND for a phase 1 trial approved by the FDA |
ImmPACT Bio | IMPT-314 | Aggressive B-cell lymphoma, including diffuse large B-cell lymphoma | IND for a phase 1/2 trial approved by the FDA |
Mirati Therapeutics | MRTX1133 | Solid tumors with KRASG12D mutations | IND for a phase 1/2 trial approved by the FDA |
Carina Biotech | CNA3103 | Advanced colorectal cancer | IND for a phase 1/2a trial approved by the FDA |
Decibel Therapeutics | DB-OTO | Congenital hearing loss caused by mutations of the otoferlin gene | Phase 1/2 trial authorized by the UK’s regulatory authority |
Diamond Therapeutics | Low-dose psilocybin | Generalized anxiety disorder | Phase 2 trial authorized by Canada’s regulatory authority |
Varian | Cardiac radioablation | High-risk refractory ventricular tachycardia | IDE approved by the FDA |
Trials Initiated | |||
ADARx Pharmaceuticals | ADX-324 | Hereditary angioedema | Initiation of a phase 1 trial |
AltruBio | ALTB-268 | Ulcerative colitis | Initiation of a phase 1 trial |
Awakn Life Sciences | (S)-ketamine | Alcohol use disorder | Initiation of a phase 1 trial |
Dyadic International | DYAI-100, COVID-19 recombinant protein receptor binding domain booster vaccine | COVID-19 | Initiation of a phase 1 trial |
Illuminare Biotechnologies | Illuminare-1 | Fluorescent agent to provide real time visualization and delineation of nerves during surgery | Initiation of a phase 1 trial |
Mersana Therapeutics | XMT-2056 | Previously treated HER2+ advanced/recurrent solid tumors | Initiation of a phase 1 trial |
Vistagen Therapeutics | PH10 pherine nasal spray | Major depressive disorder | Initiation of a phase 1 trial |
VITRAC Therapeutics | VIC-1911 and VIC-1911 plus sotorasib | KRAS G12C-mutant non-small cell lung cancer | Initiation of a phase 1 trial |
Immunis | IMM01-STEM | Muscle atrophy associated with knee osteoarthritis | Initiation of a phase 1/2a trial |
REGENXBIO | RGX-202 | Duchenne muscular dystrophy | Initiation of a phase 1/2 trial |
Eloxx Pharmaceuticals | ELX-02 | Alport syndrome with nonsense mutations in the COL4 gene | Initiation of a phase 2 trial |
Highlightll Pharmaceutical | TLL-018 | Moderate-to-severe plaque psoriasis | Initiation of a phase 2 trial |
SOTIO Biotech | Nanrilkefusp alfa | Colorectal cancer | Initiation of a phase 2 trial |
Teva Pharmaceuticals | TEV-44749 (subcutaneous long-acting injectable formulation of olanzapine) | Schizophrenia | Initiation of a phase 3 trial |
Aculys | Pitolisant | Excessive daytime sleepiness associated with obstructive sleep apnea | Initiation of a phase 3 trial in Japan |
Approvals | |||
ALK | Odactra (house dust mite allergen extract) tablet for sublingual use | House dust mite-induced allergic rhinitis in patients age 12 through 17 | Approved by the FDA for expanded age indication |
BeiGene | Brukinsa (zanubrutinib) | Chronic lymphocytic leukemia or small lymphocytic lymphoma | Approved by the FDA for new indication |
Seagen | Tukysa (tucatinib) plus trastuzumab | Previously treated RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer | Accelerated approval granted by the FDA |
TheracosBio | Brenzavvy (bexagliflozin) | Type 2 diabetes | Approved by the FDA |
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