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Pipeline
April 5, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| University of California Centers for Integrative Medicine & Health |
agarikon and turkey tail mushroom varieties | patients with early-stage COVID-19 | initiation of clinical trial |
| Gritstone Oncology | COVID-19 vaccine | COVID-19 | first patients dosed in phase 1 trial |
| Foresee Pharmaceuticals | FP-025 | adult patients with severe-to-critical COVID-19 with associated acute respiratory distress syndrome | first patients dosed in phase 2/3 trial |
| Becton Dickenson | BD Veritor Plus System rapid antigen test | detection of SARS-CoV-2, influenza A and influenza B | Emergency Use Authorization (EUA) granted by the FDA |
| Escher Biomedical Diagnostics | Escher BT-MED COV19 Saliva Test | detection of SARS-CoV-2 virus | EUA granted by the FDA |
| Other Trials and Actions | |||
| Everest Medicines | Trodelvy (sacituzumab govitecan-hziy) | cancers with high TROP-2 expression | trial authorized by the China National Medical Products Administration |
| Stoke Therapeutics | STK-001 | Dravet syndrome | trial authorized by the UK Medicines and Healthcare products Regulatory Agency |
| Curevo Vaccine | CRV-101, varicella (chickenpox) vaccine | vaccine for immunocompromised pediatrics infected with HIV | trial authorized by the South African Health Products Regulatory Authority |
| Airway Therapeutics | AT-100 (rhSP-D) | bronchopulmonary dysplasia | IND approved by the FDA |
| Antibe Therapeutics | otenaproxesul | osteoarthritis pain | IND approved by the FDA |
| Enterome | EO2463 | indolent nonHodgkin B-cell lymphomas | IND approved by the FDA |
| I-Mab ABL Bio |
TJ-CD4B/ABL111 | advanced or metastatic solid tumors | IND approved by the FDA |
| Attgeno | Supernitro | patients with life-threatening conditions associated with acute lung injury | first patients dosed in phase 1 trial |
| Aptorum Group | ALS-4 | infections caused by staphylococcus aureus, including MRSA | first patient dosed in phase 1 trial |
| D&D Pharmatech | DD01 | obese patients with diabetes and nonalcoholic fatty liver disease | first patient dosed in phase 1 trial |
| Hutchison Meditech | HMPL-306 | advanced solid tumors | initiation of phase 1 trial |
| Hutchison Meditech | HMPL-306 | hematological malignancies | initiation of phase 1 trial |
| Theratechnologies | TH1902 | sortilin-positive (SORT1+) solid tumors | first patient dosed in phase 1 trial |
| CohBar | CB4211 | nonalcoholic steatohepatitis and obesity | patient enrollment complete in phase 1b trial |
| Dermata Therapeutics | DMT310 | mild-to-moderate psoriasis | first patient dosed in phase 1b trial |
| Flexion Therapeutics | FX301 | postoperative pain following bunionectomy | first patient dosed in phase 1b trial |
| Daiichi Sankyo AstraZeneca |
Enhertu (trastuzumab deruxtecan) | patients with HER2 mutated metastatic nonsmall-cell lung cancer with disease recurrence or progression during or after at least one prior platinum-containing treatment regimen | first patient dosed in phase 2 trial |
| Intensity Therapeutics Portage Biotech |
INT230-6 (PORT-1) | early-stage breast cancer | initiation of phase 2 trial |
| Istari Oncology | PVSRIPO alone or in combination with a programmed death receptor-1/ligand 1 (PD-1/L1) inhibitor | melanoma resistant to these checkpoint therapies | first patient dosed in phase 2 trial |
| Milestone Therapeutics | etripamil nasal spray | atrial fibrillation and rapid ventricular rate | first patient enrolled in phase 2 trial |
| NeoImmuneTech | NT-I7 (efineptakin alfa) | newly diagnosed, nonsevere lymphopenic high-grade glioma following standard radiation therapy and temozolomide | first patient dosed in phase 2 trial |
| ORYZON Genomics | vafidemstat | borderline personality disorder | first patient enrolled in phase 2b trial |
| Biohaven Pharmaceuticals | oral zavegepant | preventive treatment of migraine | first patient enrolled in phase 2/3 trial |
| Exelixis | cabozantinib (Cabometyx), nivolumab (Opdivo) and ipilimumab (Yervoy) | previously untreated advanced intermediate- or poor-risk renal cell carcinoma | patient enrollment complete in phase 3 trial |
| Pharnext | PXT3003 | Charcot-Marie tooth disease type 1A | first patient enrolled in phase 3 trial |
| Fractyl Laboratories | Revita DMR (duodenal mucosal resurfacing) device | type 2 diabetes | initiation of pivotal trial |
| Moleculin Biotech | Annamycin | soft tissue sarcoma lung metastases | Fast Track designation granted by the FDA |
| Syndax Pharmaceuticals | axatilimab | chronic graft vs. host disease | Orphan Drug designation granted by the FDA |
| Premia Spine | TOPS facet arthroplasty system | joint replacement system for the lumbar spine | Breakthrough Device designation granted by the FDA |
| Astellas | Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) | neurogenic detrusor overactivity in children age three and older | approved by the FDA for expanded indication |
| Celgene/Bristol-Myers Squibb | Abecma (idecabtagene vicleucel) | adult multiple myeloma that has not responded to or has returned after at least four prior lines of therapy | approved by the FDA |
| Jazz Pharmaceuticals | Vyxeos (daunorubicin and cytarabine) | newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients age one and older | approved by the FDA for expanded indication |
| Guardant Health | Guardant360 CDx test | liquid biopsy for comprehensive tumor mutation profiling across all solid cancers | approved by the FDA |
| Medtronic | Harmony Transcatheter Pulmonary Valve | congenital heart disease | approved by the FDA |
| Amarin | Vazkepa (icosapent ethyl) | risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (?150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor | approved by the European Commission |
| Ipsen Bristol Myers Squibb |
Cabometyx (cabozantinib) plus Opdivo (nivolumab) | first-line treatment of advanced renal cell carcinoma | approved by the European Commission |
| PTC Therapeutics | Evrysdi (risdiplam) | spinal muscular atrophy in patients age two months and older | approved by the European Commission |
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