New Pipeline Updates from Pfizer, Amgen and Synchron

April 15, 2019

Company Drug/Device Medical Condition Status
Immatics IMA203 solid tumors Phase I trial initiated enrolling 15 subjects with relapsed and/or refractory solid tumors for which no standard of care therapy is available
Concert Pharmaceuticals, Inc. CTP-692 schizophrenia Phase I trial initiated
National Institutes of Health (NIH) H1ssF_3928 flu Phase I trial initiated
Synchron, Inc. Stentrode in combination with BrainOS software severe paralysis Phase I trial initiated taking place at hospitals in Melbourne, Australia
Homology Medicines, Inc. HMI-102 phenylketonuria (PKU) Phase I/II trial initiated enrolling adults aged 18 to 55 years
NanOlogy NanoDoce (sterile submicron particle docetaxel suspension) bladder cancer Phase I/II trial initiated
Provention Bio, Inc. PRV-031 (teplizumab) recent onset type 1 diabetes (T1D) Phase III trial initiated enrolling 300 subjects aged 8-17 years with recent onset T1D at 80 centers worldwide
Pfizer IBRANCE (palbociclib) men with HR+, HER2- metastatic breast cancer sNDA approval granted by the FDA
Synspira Therapeutics SNSP113 cystic fibrosis (CF) Orphan Drug designation granted by the EMA
Aggredyne, Inc. AggreGuide A 100 ADP Assay testing cartridge platelet testing technologies Clearance granted by the FDA
Spry Health Loop System chronic obstructive pulmonary disease (COPD) Clearance granted by the FDA
Viiv Healthcare Dovato (combination of dolutegravir (DTG) and lamivudine (3TC)) HIV-1 in adults who had not received treatment before Approval granted by the FDA
Amgen Evenity (romosozumab-aqqg) osteoporosis in postmenopausal women at high risk of breaking a bone (fracture) Approval granted by the FDA