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Pipeline
June 14, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Alessa Therapeutics | Biolen system in conjunction with radiation therapy | localized prostate cancer | IND approved by the FDA |
| Cullinan Oncology | CLN-049 | relapsed/refractory acute myeloid leukemia | IND approved by the FDA |
| Dynacure | DYN101 | myotubular and centronuclear myopathies | IND approved by the FDA |
| Ascletis Pharma | ASC42 | chronic hepatitis B | IND approved by the China National Medical Products Administration (NMPA) |
| Neurescue | Neurescue device | cardiac arrest treatment | Investigational Device Exemption (IDE) approved by the FDA |
| OraSure Technologies | InteliSwab | COVID-19 rapid antigen test | Emergency Use Authorization (EUA) granted by the FDA |
| Hoffman-La Roche | REGN-COV2 (casirivimab and imdevimab) | mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease | Interim Order authorization granted by Health Canada |
| Regeneron Pharmaceuticals | REGEN-COV (casirivimab and imdevimab) | mild-to-moderate COVID-19 in adults and children 12 years and older who weigh less than 40 kilograms and are at high risk for progression to severe disease | EUA revised by the FDA for lower dose |
| Alexion Pharmaceuticals | Ultomiris (ravulizumab-cwvz) | paroxysmal nocturnal hemoglobinuria in children one month of age and older and adolescents | approved by the FDA for expanded patient population |
| Biogen Eisai |
Aduhelm (aducanumab-avwa) | Alzheimer’s disease | approved by the FDA |
| Chimerix | Tembexa (brincidofovir) | smallpox vaccine | approved by the FDA |
| Liminal BioSciences/Prometic Biotherapeutics | Ryplazim (plasminogen, human-tvmh) | plasminogen deficiency type 1 (hypoplasminogenia) | approved by the FDA |
| Novo Nordisk | Wegovy (semaglutide) injection | chronic weight management in adults with obesity or who are overweight with at least one weight-related condition | approved by the FDA |
| Pfizer | Prevnar 20 (pneumococcal 20-valent conjugate vaccine) | prevention of invasive disease and pneumonia caused by the 20 streptococcus pneumoniae (pneumococcus) serotypes in adults | approved by the FDA |
| Vertex Pharmaceuticals | Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) | children with cystic fibrosis ages six through 11 who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data | approved by the FDA for expanded patient population |
| Innovent Eli Lilly |
Tyvyt (sintilimab injection) in combination with gemcitabine and platinum chemotherapy | first-line therapy for unresectable locally advanced or metastatic squamous nonsmall-cell lung cancer | approved by China’s NMPA for new indication |
| AngioDynamics | AlphaVac mechanical thrombectomy system | mechanical aspiration thrombectomy device for the nonsurgical removal of thrombi or emboli from the vasculature | approved by the FDA |
| Cardinal Health | Lymphoseek (technetium Tc 99m tilmanocept) injection | lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma or other types of solid tumors | approved by the FDA for new indication |
| Medtronic | SenSight directional lead system | deep-brain stimulation therapy | approved by the FDA |
| Neurescue | Neurescue device | temporary occlusion of large vessels, including patients requiring emergency control of hemorrhage | approved by the FDA |
| MiMedx Group | EPIFIX allografts | wound healing | approved by the Japanese Ministry of Health, Labor and Welfare |
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