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Drug & Device Pipeline News
September 6, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Approvals | |||
| Ascendis Pharma | Skytrofa (lonapegsomatropin-tcgd) | Growth failure in children age one year and older from inadequate secretion of endogenous growth hormone | Approved by the FDA |
| BeiGene | Brukinsa (zanubrutinib) | Waldenström’s macroglobulinemia | Approved by the FDA for new indication |
| Janssen | Invega Hafyera (6-month paliperidone palmitate) | Long-acting treatment of schizophrenia | Approved by the FDA |
| Merck | Keytruda | Locally advanced or metastatic urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy | Approved by the FDA for expanded indication |
| UCB | Briviact (brivaracetam) CV tablets, oral solution and injection | Partial-onset seizures in children age one month and older | Approved by the FDA for expanded indication |
| Intelivation Technologies | Golden Isles pedicle-screw system | Degenerative and traumatic procedures | Approved by the FDA |
| MicroTransponder | MicroTransponder Vivistim paired vagus nerve-stimulation system | Moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke | Approved by the FDA |
| Morphosys Incyte |
Minjuvi (tafasitamab) in combination with lenalidomide | Relapsed or refractory diffuse large B-cell lymphoma | Approved in the European Union |
| Trials Authorized | |||
| Anixa Biosciences | CAR T-cell therapy | Ovarian cancer | IND approved by the FDA |
| Diffusion Therapeutics | trans sodium crocetinate (TSC) | Interstitial lung disease | IND approved by the FDA |
| Immunolight | X-PACT X-ray psoralen-activated cancer treatment system | Solid tumors | Phase 1 trial authorized by the FDA |
| KAHR | DSP107 | Acute myeloid leukemia and myelodysplastic syndrome | IND approved by the FDA |
| Poseida Therapeutics | P-BCMA-ALLO1 | Relapsed/refractory multiple myeloma | IND approved by the FDA |
| Harbor Biomedical | batoclimab | Chronic inflammatory demyelinating polyneuropathy | IND approved by the FDA and by China’s regulatory authority |
| Laekna Therapeutics | afuresertib (LAE002) | Locally advanced or metastatic HR+, HER2- breast cancer | IND approved by the FDA and by China’s regulatory authority |
| AlzeCure Pharma | ACD856 | Alzheimer's disease | Phase 1 trial authorized by Sweden’s regulatory authority |
| Medivir | MIV-818 | Patients with hepatocellular carcinoma who have progressed on, or are intolerant of, first-line standard therapy | Phase 1/2a trial authorized by the British regulatory authority |
| Relief Therapeutics/AdVita Lifescience | Inhaled aviptadil | Sarcoidosis | Phase 2 trial authorized by the German regulatory authority |
| Trials Initiated | |||
| Lumen Bioscience | LMN-Cdiff01 | Treatment and prevention of recurrent C. difficile infection | Initiation of phase 1 trial |
| Pardes Biosciences | PBI-0451 | Antiviral to treat and prevent infections with SARS-CoV-2 | Initiation of phase 1 trial |
| Bayer | elinzanetant | Vasomotor symptoms during menopause | Initiation of phase 3 trial |
| GlaxoSmithKline SK Bioscience |
GBP510 | COVID-19 vaccine | Initiation of phase 3 trial |
| Merck Ridgeback Biotherapeutics |
molnupiravir | Postexposure prophylaxis of COVID-19 infection | Initiation of phase 3 trial |
| Pfizer | Respiratory syncytial virus (RSV) vaccine | Prevention of RSV in adults age 60 years and older | Initiation of phase 3 trial |
| Roche | giredestrant | Estrogen receptor-positive, HER2 negative early breast cancer | Initiation of phase 3 trial |
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