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Home » Drug & Device Pipeline News
Drug & Device Pipeline News
August 15, 2022
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Cure Rare Disease | CRD-TMH-001 CRISPR therapy | Duchenne muscular dystrophy | IND approved by the FDA |
Immunis | IMM01-STEM | Muscle atrophy related to knee osteoarthritis | IND approved by the FDA |
ProfoundBio | PRO1184 | Ovarian, endometrial, breast, non-small cell lung cancer and mesothelioma | IND approved by the FDA |
CereVasc | eShunt System | Communicating hydrocephalus following subarachnoid hemorrhage | IDE approved by the FDA |
Neurocrine Biosciences | NBI-1117568 | Schizophrenia | IND approved by the FDA for a phase 2 trial |
Trials Initiated | |||
Arbele Biopharmaceutical | ARB202 | Advanced gastrointestinal cancer | Initiation of phase 1 trial in Australia |
Ascletis Pharma | ASC61 | Advanced solid tumors | Initiation of phase 1 trial |
Inmagene Biopharmaceuticals HutchMed |
IMG-004 | Inflammatory and autoimmune diseases | Initiation of phase 1 trial |
Innovent Biologics | IBI324 | Diabetic macular edema | Initiation of phase 1 trial |
Upstream Bio | UPB-101 | Asthma | Initiation of phase 1b trial |
Gamida Cell | GDA-201 | Follicular and diffuse large B-cell lymphomas | Initiation of phase 1/2 trial |
Graphite Bio | GPH101 (nulabeglogene autogedtemcel) | Sickle cell disease | Initiation of phase 1/2 trial |
Tarsus Pharmaceuticals | TP-03 (lotilaner ophthalmic solution) | Meibomian gland disease in patients with Demodex mites | Initiation of phase 2a trial |
Artios | ART4215 | BRCA-deficient breast cancer | Initiation of phase 2 trial |
Disc Medicine | Bitopertin | Erythropoietic protoporphyria or X-linked protoporphyria | Initiation of phase 2 trial |
Olema Oncology | OP-1250 | ER+/HER2- metastatic breast cancer | Initiation of phase 2 trial |
Saol Therapeutics | SL-1002 | Knee pain associated with osteoarthritis | Initiation of phase 2 trial |
Noema Pharma | Gemlapodect (NOE-105) | Childhood onset fluency disorder | Initiation of phase 2b trial |
Union Therapeutics | Orismilast MR tablet | Moderate-to-severe atopic dermatitis | Initiation of phase 2b trial |
Daiichi Sankyo | Patritumab deruxtecan (HER3-DXd) | EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer | Initiation of phase 3 trial |
Pfizer Valneva |
VLA15 Lyme disease vaccine | Lyme disease | Initiation of phase 3 trial |
Approvals | |||
Myovant Sciences Pfizer |
Myfembree (relugolix, estradiol and norethindrone acetate) | Moderate-to-severe endometrial pain in premenopausal women | Approved by the FDA for new indication |
Daiichi Sankyo AstraZeneca |
Enhertu (fam-trastuzumab deruxtecan-nxki) | HER2-low metastatic breast cancer | Approved by the FDA for expanded indication |
Orion Bayer |
Nubeqa (darolutamide) | Metastatic hormone-sensitive prostate cancer | Approved by the FDA for expanded indication |
AstraZeneca Merck |
Lynparza (olaparib) | gBRCA-mutated, HER2-negative high-risk early breast cancer | Approved by the European Commission |
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