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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
PharmAbcine | PMC-403 | Neovascular age-related macular degeneration | Approval for a phase 1 trial granted by Korea’s regulatory authority |
IDEAYA Biosciences | IDE397 plus AMG 193 | Solid tumors having MTAP deletion | IND for a phase 1/2 trial approved by the FDA |
Laekna Therapeutics | LAE102 | Non-small cell lung cancer | IND for a phase 1/2 trial approved by the FDA |
Affimed | AFM13 plus AB-101 | Relapsed/ refractory classical Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma | IND for a phase 2 trial approved by the FDA |
Cumberland Pharmaceuticals | Ifetroban | Idiopathic pulmonary fibrosis | IND for a phase 2 trial approved by the FDA |
xBiotech | Natrunix | Rheumatoid arthritis | IND for a phase 2 trial approved by the FDA |
Rakuten Medical | Alluminox (ASP-1929) | Recurrent head and neck squamous cell carcinomas | Approval for a phase 3 trial granted by India’s regulatory authority |
Trials Initiated | |||
Minghui Pharmaceutical | MHB018A | Thyroid eye disease | Initiation of a phase 1a trial |
Acepodia | ACE1831 | Non-Hodgkin lymphoma | Initiation of a phase 1 trial |
AiViva Biopharma | AIV007 | Wet age-related macular degeneration and/or diabetic macular edema | Initiation of a phase 1 trial |
Kymera Therapeutics | KT-253 | Relapsed/refractory high-grade myeloid malignancies, acute lymphocytic leukemia, lymphomas, and solid tumors | Initiation of a phase 1 trial |
Cybin | CYB004 (deuterated dimethyltryptamine) | Generalized anxiety disorder and major depressive disorder | Initiation of a phase 1 trial in the Netherlands |
HiberCell | Odetiglucan plus CDX-1140 | Metastatic pancreatic ductal adenocarcinoma | Initiation of a phase 1b trial |
Topas Therapeutics | TPM502 | Celiac disease | Initiation of a phase 2a trial |
StemCyte | Umbilical cord blood cells | Post-COVID syndrome | Initiation of a phase 2a trial |
Galapagos | GLPG3667 | Dermatomyositis | Initiation of a phase 2 trial |
TrialSpark | ASN008-201 | Pruritus associated with atopic dermatitis | Initiation of a phase 2 trial |
89bio | Pegozafermin | Severe hypertriglyceridemia | Initiation of a phase 3 trial |
Approvals | |||
Bausch + Lomb Novaliq |
Miebo (perfluorohexyloctane ophthalmic solution) | Dry eye disease | Approved by the FDA |
Camerus | Brixadi (buprenorphine) extended-release injection | Moderate-to-severe opioid use disorder | Approved by the FDA |
Entasis Therapeutics | Xacduro (sulbactam and durlobactam for injection) | Hospital -acquired and ventilator-associated bacterial pneumonia | Approved by the FDA |
Genmab | Epkinly (epcoritamab-bysp) | Relapsed or refractory diffuse large B-cell lymphoma | Approved by the FDA |
Indivior | Opvee (nalmefene) nasal spray | Emergency treatment of opioid overdose | Approved by the FDA |
Krystal Biotech | Vyjuvek (beremagene geperpavec-svdt) | Dystrophic epidermolysis bullosa in patients age six months and older | Approved by the FDA |
AbbVie | Rinvoq (upadacitinib) | Moderately-to-severely active Crohn's disease | Approved by the FDA for new indication |
Blueprint Medicines | Ayvakit (avapritinib) | Indolent systemic mastocytosis | Approved by the FDA for new indication |
Abbott Laboratories | TactiFlex Ablation Catheter | Atrial fibrillation | Approved by the FDA |
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