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Drug & Device Pipeline News
January 3, 2022
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Accutar Biotech | AC0176 | Metastatic castration-resistant prostate cancer | IND approved by the FDA |
Basilea Pharmaceutica | BAL0891 | Advanced solid tumors | IND approved by the FDA |
Editas Medicine | EDIT-301 | Transfusion-dependent beta thalassemia | IND approved by the FDA |
Glycomine | GLM101 | Phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG) | IND approved by the FDA |
Lyell Immunopharma | LYL797 | ROR1+ solid tumors | IND approved by the FDA |
Rakuten | RM-1995 photoimmunotherapy | Advanced cutaneous squamous-cell carcinoma or head and neck squamous-cell carcinoma | IND approved by the FDA |
Regor Therapeutics | RGT-419B | HER2-, HR+ breast cancer | Study May Proceed granted by the FDA |
Sorrento Therapeutics | STI-1386 | Relapsed or refractory solid tumors | IND approved by the FDA |
Tryp Therapeutics | Synthetic psilocybin | Binge eating disorder | Study May Proceed granted by the FDA |
Sedana Medical | Sedaconda (isoflurane) | Sedation of mechanically ventilated intensive care patients | IND approved by the FDA |
I-Mab | Enoblituzumab in combination with Keytruda (pembrolizumab) | Solid tumors | IND approved by China’s regulatory authorities |
IRLAB | Pirepemat | Parkinson's disease | Regulatory approval for a phase 2 trial granted by Sweden’s regulatory authorities |
Trials Initiated | |||
Bio-Thera | BAT6005 | Advanced solid tumors | Initiation of phase 1 trial |
Bio-Thera | BAT6026 | Advanced solid tumors | Initiation of phase 1 trial |
Immunolight | X-PACT Cancer Treatment system | Breast, melanoma, sarcoma and head and neck cancers | Initiation of phase 1 trial |
Oramed Pharmaceuticals | Oral virus-like particle (VLP) COVID-19 vaccine | COVID-19 vaccine | Initiation of phase 1 trial in South Africa |
Axcella | AXA1125 | Long COVID/postCOVID-19 condition | Initiation of phase 2a trial |
Alnylam | Lumasiran | Recurrent kidney stone disease and elevated urinary oxalate levels | Initiation of phase 2 trial |
Fortress Biotech Helocyte |
Triplex | Cytomegalovirus vaccine | Initiation of phase 2 trial |
Jazz Pharmaceuticals | JZP150 | Adults with post-traumatic stress disorder | Initiation of phase 2 trial |
PharmAbcine | Olinvacimab plus Keytruda | Metastatic triple-negative breast cancer | Initiation of phase 2 trial in Australia |
Aptinyx | NYX-783 | Post-traumatic stress disorder | Initiation of phase 2b trial |
ILiAD Biotechnologies | BPZE1 | Live attenuated intranasal pertussis vaccine | Initiation of phase 2b trial |
Saniona | Tesomet | Prader-Willi syndrome | Initiation of phase 2b trial |
Daiichi Sankyo Astrazeneca |
Enhertu (trastuzumab deruxtecan) | HER2-mutant unresectable, locally advanced or metastatic nonsquamous, nonsmall-cell lung cancer | Initiation of phase 3 trial |
Eiger Biopharma | Peginterferon Lambda | Chronic hepatitis delta virus infection | Initiation of phase 3 trial |
Kolon TissueGene | TG-C | Knee osteoarthritis | Initiation of phase 3 trials |
Navidea | NAV3-33 | Rheumatoid arthritis | Initiation of phase 3 trial |
Novavax | NVX-CoV2373 | COVID-19 vaccine with Matrix-M adjuvant | Initiation of phase 3 trial |
Palatin Technologies | PL9643 | Dry eye disease | Initiation of phase 3 trial |
Approvals | |||
Amgen AstraZeneca |
Tezspire (tezepelumab-ekko) | Add-on maintenance treatment for patients >12 years with severe asthma | Approved by the FDA |
Amgen | Otezla (apremilast) | Adults with plaque psoriasis across all severities | Approved by the FDA for expanded indication |
argenx | Vyvgart (efgartigimod) | Generalized myasthenia gravis in adults with AChR antibody | Approved by the FDA |
Calliditas Therapeutics | Tarpeyo (budesonide) delayed release capsules | Primary immunoglobulin A nephropathy | Accelerated approval granted by the FDA |
Daiichi Sankyo American Regent | Injectafer (ferric carboxymaltose injection) | Pediatric patients with iron deficiency anemia | Approved by the FDA |
Global Blood Therapeutics | Oxbryta (voxelotor) | Sickle cell disease in children ages four to 11 years | Approved by the FDA for expanded indication |
Intra-Cellular Therapies | Caplyta (lumateperone) | Bipolar depression in adults | Approved by the FDA |
Janssen Pharmaceuticals | Xarelto (rivaroxaban) | Prevention and treatment of venous thromboembolism in pediatrics | Approved by the FDA for new indications |
LEO Pharma | Adbry (tralokinumab-ldrm) | Atopic dermatitis | Approved by the FDA |
Novartis | Leqvio (inclisiran) | To lower low-density lipoprotein cholesterol | Approved by the FDA |
Novartis | Cosentyx (secukinumab) | Active enthesitis-related arthritis in patients four years and older, and active psoriatic arthritis in patients two years and older | Approved by the FDA for expanded indication |
Merck Ridgeback Biotherapeutics |
Molnupiravir | Mild-to-moderate COVID-19 infections in adults who are at high risk of progression to severe disease | Emergency Use Authorization (EUA) granted by the FDA |
Pfizer | Paxlovid (nirmatrelvir and ritonavir tablets) | High-risk adults and pediatric patients 12 years and older to treat COVID-19 | EUA granted by the FDA |
ViiV Healthcare | Apretude (cabotegravir extended-release injectable suspension) | Pre-exposure prophylaxis of HIV | Approved by the FDA |
Edwards Lifesciences | Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent | Severe pulmonary regurgitation | Approved by the FDA |
Sight Sciences | TearCare System | Meibomian gland dysfunction | Approved by the FDA |
Telix Pharmaceuticals | Illuccix | Prostate cancer imaging | Approved by the FDA |
Gilead Sciences | Veklury (remdesivir) | Adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19 | Approved by the European Commission for expanded indication |
Merck | Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) | Vaccine for invasive disease and pneumonia caused by Streptococcus pneumoniae | Approved by the European Commission |
Novavax | Nuvaxovid COVID-19 vaccine | COVID-19 vaccine | Conditional marketing authorization granted by the European Commission |