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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

November 22, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
InnoCare Pharma ICP-189 Advanced solid tumors IND approved by the FDA
MyMD Pharmaceuticals MYMD-1 Aging IND approved by the FDA for a phase 2 trial
Paradigm Biopharmaceuticals Zilosul (pentosan polysulphate sodium) Knee osteoarthritis pain IND approved by the FDA for a phase 3 trial
Vitro Biopharma AlloRx stem cells Pitt Hopkins syndrome IND approved by the FDA
Cardialen MultiPulse therapy Paroxysmal and persistent atrial fibrillation IDE approved by the FDA
Paracrine Celution system to deliver adipose derived regenerative cells Diabetic foot ulcers IDE approved by the FDA
MimiVax SurVaxM Newly diagnosed glioblastoma Approval for a phase 2b trial granted by the FDA
Emergex Vaccines COVID-19 vaccine COVID-19 Approval for a phase 1 trial granted by Switzerland’s regulatory authority
Gannex Pharma ASC42 Primary biliary cholangitis Approval for phase 2 and 3 trials granted by China’s regulatory authority
HebaBiz Biotech Clevudine (L-FMAU) Chronic hepatitis B virus Approval for phase 3 trial granted by China’s regulatory authority
Trials Initiated
Revelation Biosciences REVTx-99 Allergic rhinitis and chronic nasal congestion without polyps Initiation of phase 1b trial in Australia
Eureka Therapeutics ET140203 ARTEMIS T-cell therapy Pediatric cases of relapsed or refractory hepatoblastoma, hepatocellular neoplasm not otherwise specified or hepatocellular carcinoma Initiation of phase 1/2 trial
Graphite Bio GPH101 Sickle cell disease Initiation of phase 1/2 trial
Inozyme Pharma INZ-701 ENPP1 deficiency in adults Initiation of phase 1/2 trial
NiKang Therapeutics NKT2152 Clear-cell renal-cell carcinoma Initiation of phase 1/2 trial
Rafael Pharmaceuticals CPI-613 (devimistat) Clear-cell sarcoma Initiation of phase 1/2 trial
Biosight Aspacytarabine (BST-236) Relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia Initiation of phase 2 trial
Dermata Therapeutics DMT310 Moderate-to-severe rosacea Initiation of phase 2 trial
Oryzon Vafidemstat Schizophrenia Initiation of phase 2b trial in Spain
Saniona Tesomet Hypothalamic obesity Initiation of phase 2b trial
Merck Verquvo (vericiguat) Chronic heart failure and reduced ejection fraction in patients who have not had a recent worsening heart-failure event Initiation of phase 3 trial
Approvals
Merck Keytruda Adjuvant treatment of patients with renal-cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions Approved by the FDA for expanded indication
PharmaEssentia Besremi (ropeginterferon alfa-2b-njft) Polycythemia vera Approved by the FDA
AbbVie Skyrizi (risankizumab) Active psoriatic arthritis in adults Approved by the European Commission

 

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