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

January 22, 2018

Company Drug/Device Medical Condition Status
Tetra Bio-Pharma PPP005 safety study Phase I trials planned in Canada
Constellation Pharmaceuticals CPI-1205 oncology Phase Ib/II trials initiated
CytRx Aldoxorubicin metastatic pancreatic cancer Phase Ib/II trials initiated enrolling 173 subjects
Transgene TG4010 MUC1 expressing tumors Phase II trials initiated enrolling 39 subjects
Ophthotech Zimura (avacincaptad pegol) autosomal recessive Stargardt disease (STGD1) Phase IIb trials initiated enrolling 120 subjects
MiMedx AmnioFix Injectable recalcitrant plantar fasciitis pain Phase III trials initiated enrolling 164 subjects
LivaNova Aortic Valve Implant reporting of reduced leaflet motion Post-Market trials initiated enrolling 230 subjects in the U.S. and Canada
Aspyrian Therapeutics RM-1929 locoregional recurrent head and neck squamous cell carcinoma Fast Track designation granted by the FDA
Centrexion CNTX-4975 pain associated with knee osteoarthritis Fast Track designation granted by the FDA
Concert Pharmaceuticals CTP-543 moderate to severe alopecia areata Fast Track designation granted by the FDA
Cour Pharmaceuticals TIMP-GLIA Celiac disease Fast Track designation granted by the FDA
Benitec BioPharma BB-301 oculopharyngeal muscular dystrophy Orphan Drug designation granted by the FDA
Helsinn, MEI Pharma pracinostat acute myeloid leukemia Orphan Drug designation granted by the EMA
Novartis Kymriah (tisagenlecleucel) relapsed or refractory diffuse large B-cell lymphoma Priority Review granted by the FDA, Accelerated Assessment granted by the EMA
ACON Laboratories, Innovus Pharma UriVarx Urinary Tract Infection test strips overactive bladder, urinary incontinence FDA administration clearance
AstraZeneca, Merck Lynparza (olaparib) deleterious or suspected deleterious gBRCAm HER2-negative metastatic breast cancer FDA approved
Avion Pharmaceuticals Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) oral contraceptive FDA approved
Boehringer Ingelheim Gilotrif (afatinib) metastatic non-small cell lung cancer with non-resistant EGFR mutations FDA approved
GlaxoSmithKline Fluarix Quadrivalent (Influenza Vaccine) flu in patients 3 years of age or older FDA expanded indication approved
Innovus Pharma Xyralid (DIN 02471434) pain and symptom relief for hemorrhoids Health Canada approved
Myriad Genetics BRACAnalysis CDx HER2-negative metastatic breast cancer with germline BRCA mutation FDA approved