
Home » Drug & Device Pipeline News
Drug & Device Pipeline News
This week’s Pipeline features a phase 1 trial approval for liver cancer, a phase 2 trial start for lymphatic malformations in pediatric patients and an FDA device approval for coronary artery disease.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Biosyngen | BST02 | Liver cancer | IND for a phase 1 trial approved by the FDA |
Endogena Therapeutics | EA 2351 | Geographic atrophy | IND for a phase 1 trial approved by the FDA |
KaliVir Immunotherapeutics | ASP1012 | Locally advanced/metastatic solid tumors | IND for a phase 1 trial approved by the FDA |
Rise Therapeutics | R-2487 | Rheumatoid arthritis | IND for a phase 1 trial approved by the FDA |
PHAXIAM Therapeutics | PHAXIAM phages | Endocarditis infections caused by staphylococcus aureus | Approval for a phase 1 trial granted by France’s regulatory authority |
Verve Therapeutics | VERVE-101 | Heterozygous familial hypercholesterolemia | IND for a phase 1b trial approved by the FDA |
ReAlta Life Sciences | RLS-0071 | Acute exacerbations of chronic obstructive pulmonary disease | IND for a phase 2 trial approved by the FDA |
Lipella Pharmaceuticals | LP-310 | Symptomatic oral lichen planus | IND for a phase 2a trial approved by the FDA |
MTF Biologics | FlexHD Pliable | Implant-based breast reconstruction | IDE approved by the FDA |
Trials Initiated | |||
Iksuda Therapeutics | IKS014 | Advanced HER2+ solid tumors | Initiation of a phase 1 trial in Australia |
Aurion Biotech | AURN001 | Corneal edema secondary to corneal endothelial dysfunction | Initiation of a phase 1/2 trial |
Boehringer Ingelheim | BI 764532 | Small cell lung cancer and other neuroendocrine cancers | Initiation of a phase 2 trial |
Oxular | OXU-001 | Diabetic macular edema | Initiation of a phase 2 trial |
Protara Therapeutics | TARA-002 | Treatment of pediatric patients with lymphatic malformations | Initiation of a phase 2 trial |
Sparrow Pharmaceuticals | SPI-62 | Autonomous cortisol secretion | Initiation of a phase 2 trial |
BioNTech | Autogene cevumeran plus atezolizumab and chemotherapy | Resected pancreatic ductal adenocarcinoma | Initiation of a phase 2 trial |
Sabin Vaccine Institute | Marburg virus vaccine | Marburg virus | Initiation of a phase 2 trial in Uganda |
Acasti Pharma | GTX-104 | Aneurysmal subarachnoid hemorrhage | Initiation of a phase 3 trial |
Moderna Therapeutics | mRNA-1083 influenza and COVID-19 combination vaccine | Influenza and COVID-19 | Initiation of a phase 3 trial |
Renibus Therapeutics | RBT-1 | Postoperative complications following cardiothoracic surgery | Initiation of a phase 3 trial |
Approvals | |||
Bausch Health | Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel | Acne vulgaris in patients age 12 and older | Approved by the FDA |
Pfizer | Penbraya (meningococcal groups A, B, C, W and Y vaccine) | Meningococcal disease in patients age 10 to 25 | Approved by the FDA |
BioMarin | Voxzogo (vosoritide) | Achondroplasia in children of all ages with open growth plates | Approved by the FDA for expanded age indication |
Genentech | Rozlytrek (entrectinib) oral pellet formulation | Treatment of pediatric patients with solid tumors harboring a NTRK gene fusion | Approved by the FDA for new formulation |
Celltrion | Zymfentra (infliximab-dyyb) subcutaneous formulation | Moderately-to-severely active ulcerative colitis and Crohn’s disease after treatment with an intravenous infliximab product | Approved by the FDA for new formulation |
Servier Pharmaceuticals | Tibsovo (ivosidenib tablets) | Relapsed/ refractory myelodysplastic syndromes with IDH1 mutations | Approved by the FDA for new indication |
Medinol | EluNIR-PERL drug-eluting stent | Coronary artery disease | Approved by the FDA |
Upcoming Events
-
14Apr