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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
COVID-19 Trials and Actions | |||
OSE Immunotherapeutics | CoVepiT | COVID-19 vaccine | approval received from the Belgian Federal Agency for Medicines and Health Products for phase 1 trial |
AzurRx Biopharma | micronized niclosamide (FW-1022) | COVID-19-related gastrointestinal infections | initiation of phase 2 trial |
The Cancer Research Institute RevImmune |
interleukin-7 (IL-7) | cancer patients with COVID-19 | first patients dosed in phase 2 trial |
Novavax | NVX-CoV2373 | COVID-19 vaccine | initiation of phase 2b and 3 trials |
Abbott | BinaxNOW COVID-19 Ag Self Test | detection of COVID-19 infection | Emergency Use Authorization (EUA) granted by the FDA |
Baebies | FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test – RT-PCR | detection of COVID-19 infection | EUA granted by the FDA |
Quidel | QuickVue At-Home OTC COVID-19 Test | detection of COVID-19 infection | EUA granted by the FDA |
Other Trials and Actions | |||
Arcellx | ACLX-001 | multiple myeloma | IND approved by the FDA |
BioInvent International | BI-1808 | ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma | IND approved by the FDA |
Landos Biopharma | omilancor (BT-11) | eosinophilic esophagitis | IND approved by the FDA |
Tarus Therapeutics | TT-10 | advanced solid tumors | IND approved by the FDA |
Antengene Corporation | ATG-019 (monotherapy or combined with niacin ER) | advanced solid tumors or nonHodgkin lymphoma | IND approved by the China National Medical Products Administration |
BlueRock Therapeutics | MSK-DA01 Cell Therapy | advanced Parkinson's disease | approval received from Health Canada for a phase 1 trial |
Azafaros | AZ-3102 | GM1 and GM2 gangliosidoses | first cohort dosed in phase 1 trial |
Celon Pharma | CPL’280 | diabetes and diabetic neuropathy | completion of phase 1 trial |
I-Mab ABL Biotechnologies |
TJ-L14B/ABL503 | locally advanced or metastatic solid tumors | first patient dosed in phase 1 trial |
Nascent Biotech | pritumumab | brain cancer, including malignant primary brain tumors and adult brain metastases | initiation of phase 1 trial |
TeneoBio Janssen |
JNJ-75348780 | B-cell lymphoid malignancies | first patients dosed in phase 1 trial |
Pinteon Therapeutics | PNT001 | acute traumatic brain injury | first patient dosed in phase 1b trial |
SpringWorks Therapeutics | nirogacestat | nirogacestat in combination with teclistamab | first patient dosed in phase 1b trial |
Daiichi Sankyo | DS-1594 | relapsed/refractory acute myeloid leukemia and acute lymphoblastic leukemia | initiation of phase 1/2 trial |
Gracell Biotechnologies | GC007g | B-cell acute lymphoblastic leukemia | first patient enrolled in phase 1/2 trial |
Molecular Partners | ensovibep | patients with symptomatic COVID-19 | first patient dosed in phase 2a trial |
Recognify Life Sciences/atai Life Sciences | RL-007 | cognitive impairment associated with schizophrenia | initiation of phase 2a trial |
AEON Biopharma | ABP-450 (prabotulinumtoxinA) injection | cervical dystonia | first patients dosed in phase 2 trial |
Aptinyx | NYX-458 | patients with mild cognitive impairment and mild dementia associated with Parkinson’s disease and dementia with Lewy bodies | restarted patient screening in phase 2 trial |
Chinook Therapeutics | atrasentan | patients with proteinuric glomerular disease who are at risk of progressive loss of renal function | first patient dosed in phase 2 trial |
Daiichi Sankyo AstraZeneca |
Enhertu (trastuzumab deruxtecan) | HER2 overexpressing locally advanced, unresectable or metastatic colorectal cancer with progression following treatment with standard-of-care chemotherapy | first patient dosed in phase 2 trial |
Enzychem Lifesciences | EC-18 | chemoradiation induced oral mucositis | patient enrollment complete in stage 2 of phase 2 trial |
Kadmon | belumosudil | diffuse cutaneous systemic sclerosis | first patient dosed in phase 2 trial |
Ocuphire Pharma | APX3330 | nonproliferative diabetic retinopathy and mild proliferative diabetic retinopathy | initiation of phase 2 trial |
Ionis Pharmaceuticals | ION363 | amyotrophic lateral sclerosis with mutations in the fused-in sarcoma gene | initiation of phase 3 trial |
Relmada Therapeutics | REL-1017 | adjunctive treatment for major depressive disorder | initiation of phase 3 trial |
Da Volterra | DAV132 | prevention of clostridioides difficile infection in high-risk patients | Fast-Track designation granted by the FDA |
Passage Bio | PBKR03 | Krabbe disease | Orphan Drug designation granted by the European Commission |
Taiho Oncology | futibatinib (TAS-120) | treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions | Breakthrough Therapy designation granted by the FDA |
Sanofi | Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone | treatment of patients with relapsed refractory multiple myeloma who have received one to three prior lines of therapy | approved by the FDA for expanded indication |
Supernus Pharmaceuticals | Qelbree (viloxazine extended-release capsules) | attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age | approved by the FDA |
United Therapeutics | Tyvaso (treprostinil) Inhalation Solution | pulmonary hypertension associated with interstitial lung disease | approved by the FDA |
Bausch and Lomb | ClearVisc dispersive ophthalmic viscosurgical device | ophthalmic surgery | approved by the FDA |
Chemence Medical | Exofin fusion skin closure system | topical adhesive to close and seal incisions | approved by the FDA |
NuVasive | NuVasive Simplify Cervical Artificial Disc | two-level cervical total disc replacement | approved by the FDA |
Respinova | Pulsehaler | inhaler for patients with respiratory diseases | approved by the FDA |
Vysioneer | VBrain, AI-powered tumor autocontouring solution | radiotherapy treatment | approved by the FDA |
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