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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

November 8, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Antengene ATG-101 Metastatic/advanced solid tumors and B-cell nonHodgkin’s lymphoma IND for a phase 1 trial approved by the FDA and by China’s regulatory authority
Oravax Medical Oral COVID-19 vaccine COVID-19 Phase 1 trial approved by South Africa’s regulatory authority
BioTheryX BTX-1188 Hematologic and solid malignancies IND for a phase 1 trial approved by the FDA
Antengene onatasertib in combination with selinexor Relapsed/refractory diffuse large B-cell lymphoma IND for a phase 1b trial approved by China’s regulatory authority
Memgen MEM-288 Multiple solid tumors IND for a phase 1 trial approved by the FDA
Ikena Oncology IK-930 Therapy for cancer patients who exhibit genetic alterations across the Hippo pathway IND for a phase 1 trial approved by the FDA
Theseus Pharmaceuticals THE-630 Gastrointestinal stromal tumors IND for phase 1/2 dose-escalation and expansion trial approved by the FDA
Landos Biopharma LABP-104 Rheumatoid arthritis IND for a phase 1 trial approved by the FDA
Impact Therapeutics IMP9064 as a monotherapy and in combination with senaparib (IMP4297) Patients with advanced solid tumors IND for a phase 1/2 trial approved by the FDA
Bionomics BNC210 Social anxiety disorder IND for a phase 2 trial approved by the FDA
Akeso AK112 as a monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy Resectable nonsmall-cell lung cancer IND for a phase 2 trial approved by China’s regulatory authority
Rapid Medical Interventional stroke treatment Distal thrombectomy Investigational device exemption approved by the FDA
Gannex Pharma

Ascletis Pharma
ASC43F Nonalcoholic steatohepatitis IND approved by the FDA
Trials Initiated
OncoResponse OR2805 Patients with advanced cancer Initiation of a phase 1/2 trial
Talaris Therapeutics FCR001 Kidney transplantation Initiation of a phase 2 trial
HutchMed

AstraZeneca
savolitinib in combination with Imfinzi (durvalumab) MET-driven advanced papillary renal-cell carcinoma Initiation of a phase 3 trial
Ionis olezarsen Severe hypertriglyceridemia Initiation of a phase 3 trial
Approvals
Pfizer

BioNTech
Pfizer-BioNTech COVID-19 Vaccine COVID-19 Emergency Use Authorization (EUA) granted for children age five through 11 years as a two-dose regimen given 21 days apart
ANI Pharmaceuticals Purified Cortrophin Gel (repository corticotropin injection USP) Chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis and excess urinary protein due to nephrotic syndrome Approved by the FDA
Novartis Scemblix (asciminib) Chronic myeloid leukemia (CML) Approved by the FDA for adults with Philadelphia chromosome-positive CML in chronic phase with T315I mutation; accelerated approval for adults with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors based on molecular response rate at 24 weeks
AbbVie Vuity (pilocarpine HCl ophthalmic solution) 1.25 percent Adults with presbyopia (age-related farsightedness) Approved by the FDA
Insightec Exablate Neuro Advanced Parkinson's disease with mobility, rigidity or dyskinesia symptoms Approved by the FDA
GenBody America Visually readable COVID-19 antigen test kit COVID-19 EUA granted by the FDA

 

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