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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

November 21, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
YS Biopharma PIKA COVID-19 vaccine COVID-19 IND approved by the FDA
Gmax Biopharm GMA131 Diabetic kidney disease IND approved by the FDA
Ascletis Pharma ASC10 Monkeypox IND approved by the FDA for phase 1b trial
Asieris Pharmaceuticals APL-1401 Moderately-to-severely active ulcerative colitis IND approved by the FDA for phase 1b trial
J INTS BIO JIN-A02 Advanced non-small cell lung cancer IND approved by the FDA for phase 1/2 trial
NeuroSense Therapeutics PrimeC Amyotrophic lateral sclerosis IND approved by the FDA for phase 2b trial
AUM Biosciences AUM001 Metastatic colorectal cancer Approval for a phase 2 trial granted by Australia’s regulatory authority
Trials Initiated
Virogin Biotech VG201 Advanced solid tumors Initiation of phase 1 trial
Beam Therapeutics BEAM-101 Severe sickle cell disease in adults Initiation of phase 1/2 trial
Equillium EQ101 Alopecia areata Initiation of phase 2 trial
EpiEndo Pharmaceuticals EP395 Chronic obstructive pulmonary disease Initiation of phase 2a trial in Germany and the UK
Ayala Pharmaceuticals AL102 Desmoid tumors Initiation of phase 3 trial
Innovent Biologics Mazdutide (IBI362) Obesity Initiation of phase 3 trial in China
Approvals
Sobi North America Kineret (anakinra) COVID-19-related pneumonia in hospitalized adults requiring supplemental oxygen Emergency Use Authorization granted by the FDA
AstraZeneca Imfinzi (durvalumab) plus Imjudo (tremelimumab) plus platinum-based chemotherapy Non-small cell lung cancer Approved by the FDA
ImmunoGen Elahere (mirvetuximab soravtansine-gynx) Treatment of previously treated adults with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer Accelerated approval granted by the FDA
Medicines360 Liletta (levonorgestrel-releasing intrauterine system) Pregnancy prevention for up to eight years Approved by the FDA for extended treatment duration
Seagen Adcetris (brentuximab vedotin) Previously untreated high-risk classical Hodgkin lymphoma in children age two years and older Approved by the FDA for expanded age indication
Agios Pharmaceuticals Pyrukynd (mitapivat) Pyruvate kinase deficiency in adults Approved in the EU

 

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