Pipeline new from Bonti, Amneal, Janssen, PaxVax and Genentech

May 14, 2018

Company Drug/Device Medical Condition Status
Nektar Therapeutics NKTR-358 systemic lupus erythematosus (SLE) Phase Ib trial initiated evaluating 50 subjects
Bonti, Inc. EB-001T elective abdominoplasty surgery Phase II trial initiated
Amneal IPX203 advanced Parkinson’s disease Phase III trial initiated to enroll 500 subjects
Prisyna, the oral care division of Synedgen Moisyn product line xerostomia 510(k) clearance granted by the FDA
C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers 510(k) clearance granted by the FDA
Palladio Biosciences. Inc. lixivaptan capsules autosomal dominant polycystic kidney disease (ADPKD) IND clearance granted by the FDA
Portola Pharmaceuticals Andexxa antidote for blood thinners rivaroxaban and apixaban Approval granted by the FDA
Janssen Pharmaceutical Companiesof Johnson & Johnson DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) Approval granted by the FDA
PaxVax, Inc. Chikungunya vaccine prevention of the chikungunya virus Fast Track Designation granted by the FDA
Debiopharm International SA Debio 1347 (FGFR 1-3 Inhibitor) unresectable or metastatic tumors with a specific FGFR gene alteration Fast Track Designation granted by the FDA
Genentech Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) first-line treatement of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) Priority Review granted by the FDA