Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Antengene | ATG-101 | Metastatic/advanced solid tumors and B-cell nonHodgkin’s lymphoma | IND for a phase 1 trial approved by the FDA and by China’s regulatory authority |
| Oravax Medical | Oral COVID-19 vaccine | COVID-19 | Phase 1 trial approved by South Africa’s regulatory authority |
| BioTheryX | BTX-1188 | Hematologic and solid malignancies | IND for a phase 1 trial approved by the FDA |
| Antengene | onatasertib in combination with selinexor | Relapsed/refractory diffuse large B-cell lymphoma | IND for a phase 1b trial approved by China’s regulatory authority |
| Memgen | MEM-288 | Multiple solid tumors | IND for a phase 1 trial approved by the FDA |
| Ikena Oncology | IK-930 | Therapy for cancer patients who exhibit genetic alterations across the Hippo pathway | IND for a phase 1 trial approved by the FDA |
| Theseus Pharmaceuticals | THE-630 | Gastrointestinal stromal tumors | IND for phase 1/2 dose-escalation and expansion trial approved by the FDA |
| Landos Biopharma | LABP-104 | Rheumatoid arthritis | IND for a phase 1 trial approved by the FDA |
| Impact Therapeutics | IMP9064 as a monotherapy and in combination with senaparib (IMP4297) | Patients with advanced solid tumors | IND for a phase 1/2 trial approved by the FDA |
| Bionomics | BNC210 | Social anxiety disorder | IND for a phase 2 trial approved by the FDA |
| Akeso | AK112 as a monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy | Resectable nonsmall-cell lung cancer | IND for a phase 2 trial approved by China’s regulatory authority |
| Rapid Medical | Interventional stroke treatment | Distal thrombectomy | Investigational device exemption approved by the FDA |
| Gannex Pharma Ascletis Pharma |
ASC43F | Nonalcoholic steatohepatitis | IND approved by the FDA |
| Trials Initiated | |||
| OncoResponse | OR2805 | Patients with advanced cancer | Initiation of a phase 1/2 trial |
| Talaris Therapeutics | FCR001 | Kidney transplantation | Initiation of a phase 2 trial |
| HutchMed AstraZeneca |
savolitinib in combination with Imfinzi (durvalumab) | MET-driven advanced papillary renal-cell carcinoma | Initiation of a phase 3 trial |
| Ionis | olezarsen | Severe hypertriglyceridemia | Initiation of a phase 3 trial |
| Approvals | |||
| Pfizer BioNTech |
Pfizer-BioNTech COVID-19 Vaccine | COVID-19 | Emergency Use Authorization (EUA) granted for children age five through 11 years as a two-dose regimen given 21 days apart |
| ANI Pharmaceuticals | Purified Cortrophin Gel (repository corticotropin injection USP) | Chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis and excess urinary protein due to nephrotic syndrome | Approved by the FDA |
| Novartis | Scemblix (asciminib) | Chronic myeloid leukemia (CML) | Approved by the FDA for adults with Philadelphia chromosome-positive CML in chronic phase with T315I mutation; accelerated approval for adults with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors based on molecular response rate at 24 weeks |
| AbbVie | Vuity (pilocarpine HCl ophthalmic solution) 1.25 percent | Adults with presbyopia (age-related farsightedness) | Approved by the FDA |
| Insightec | Exablate Neuro | Advanced Parkinson's disease with mobility, rigidity or dyskinesia symptoms | Approved by the FDA |
| GenBody America | Visually readable COVID-19 antigen test kit | COVID-19 | EUA granted by the FDA |
Upcoming Events
-
01Dec
-
08Dec
-
13Dec
