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Home » Drug & Device Pipeline News
Drug & Device Pipeline News
May 1, 2023
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Invivyd | VYD222 | Prevention of COVID-19 in vulnerable people | IND for a phase 1 trial approved by the FDA |
Bridge Biotherapeutics | BBT-207 | Non-small cell lung cancer with EGFR mutations | IND for a phase 1/2 trial approved by the FDA |
Direct Biologics | ExoFlo | Medically refractory perianal fistulizing Crohn’s disease | IND for a phase 1/2 trial approved by the FDA |
Stoke Therapeutics | STK-002 | Autosomal dominant optic atrophy | IND for a phase 1/2 trial approved by the UK’s regulatory authority |
Trials Initiated | |||
Avacta | AVA6000 | Locally advanced or metastatic solid tumors | Initiation of a phase 1 trial |
Janux Therapeutics | JANX008 | Advanced or metastatic solid tumors | Initiation of a phase 1 trial |
Oblato | OKN-007 | Recurrent high-grade glioma | Initiation of a phase 1 trial |
AbbVie Calico Life Sciences |
ABBV-CLS-7262 | Vanishing white matter disease | Initiation of a phase 1b trial |
Elicio Therapeutics | ELI-002 7P | KRAS/NRAS mutated solid tumors | Initiation of a phase 1/2 trial |
Contrafect | Exebacase | Chronic prosthetic joint infections of the knee | Initiation of a phase 1b/2 trial |
Artelo Biosciences | ART27.13 | Cancer-related anorexia and weight loss | Initiation of a phase 2a trial |
Aphaia Pharma | APH-012 | Prediabetes | Initiation of a phase 2 trial |
CinRx Pharma | Deudomperidone | Diabetic gastroparesis | Initiation of a phase 2 trial |
Okyo Pharma | OK-101 ophthalmic solution | Dry eye disease | Initiation of a phase 2 trial |
Sunovion Pharmaceuticals Otsuka Pharmaceutical |
Ulotaront | Generalized anxiety disorder | Initiation of a phase 2/3 trial |
Galapagos | Filgotinib | Active radiographic and nonradiographic axial spondyloarthritis | Initiation of two phase 3 trials |
I-Mab Biopharma | Lemzoparlimab plus azacitidine | Higher-risk myelodysplastic syndrome | Initiation of a phase 3 trial in China |
Approvals | |||
Biogen Ionis |
Qalsody (tofersen) | SOD1-amyotrophic lateral sclerosis | Accelerated approval granted by the FDA |
Galderma | Sculptra (injectable poly-L-lactic acid) | Cheek wrinkles | Approved by the FDA |
Seres Therapeutics Nestlé Health Science |
Vowst (fecal microbiota spores, live-brpk) | Recurrent C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI | Approved by the FDA |
Vertex Pharmaceuticals | Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) | Treatment of children with cystic fibrosis age two through five years with certain mutations | Approved by the FDA for expanded age indication |
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