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Twenty Drugs and Devices have Entered a New Trial Phase This Week

January 29, 2018

Company Drug/Device Medical Condition Status
Apexian Pharmaceuticals APX3330 advanced solid tumors Phase I trials initiated
Bavarian Nordic BN-Brachyury cancer metastasis Phase I trials initiated enrolling 10 subjects
Protalex PRTX-100 (PRTX-100-203 Study) persistent/chronic Immune Thrombocytopenia Phase Ib trials initiated enrolling 30 subjects in Europe
IntelGenx Montelukast VersaFilm Alzheimer’s disease Phase IIa trials initiated
Biomarck Pharmaceutical BIO-11006 non-small cell lung cancer Phase II trials initiated in India
Melinta Therapeutics radezolid bacterial vaginosis Phase II trials initiated
TrovaGene PCM-075 + Zytiga metastatic castration-resistant prostate cancer Phase II trials initiated enrolling 25 subjects
Evofem Biosciences Amphora prevention of urogenital chlamydia and gonorrhea in women Phase IIb/III trials initiated enrolling 850 subjects in the U.S.
GC Pharma GC1102 hepatitis B virus infection following liver transplantation Phase II/III trials planned
Swedish Orphan Biovitrum SOBI003 mucopolysaccharidosis type IIIA Fast Track designation granted by the FDA
Astellas Pharma gilteritinib acute myeloid leukemia Orphan Drug designation granted by the EC
BERG BPM31510 pancreatic cancer Orphan Drug designation granted by the FDA
Enzychem Lifesciences EC-18 acute radiation syndrome Orphan Drug designation granted by the FDA
Nohla Therapeutics NLA101 hematopoietic stem cell transplantation Orphan Drug designation granted by the EC
Omeros OMS721 primary Immunoglobulin A nephropathy Orphan Drug designation granted by the EMA
Orphazyme arimoclomol Niemann-Pick disease Type C Rare Pediatric Disease designation granted by the FDA
Genmab daratumumab (Darzalex) + bortezomib, melphalan and prednisone newly diagnosed multiple myeloma Priority Review granted by the FDA
Baxter International Bivalirudin anticoagulant in patients undergoing percutaneous coronary intervention FDA approved
Bristol-Myers Squibb Yervoy (ipilimumab) advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older EC expanded indication approved
Takeda Pharmaceutical Adcetris (brentuximab vedotin) CD30-positive cutaneous T-cell lymphoma EC extended current conditional marketing authorization