New Pipeline Updates from Eli Lilly, Bone Therapeutics, Shoulder Innovations and BD

November 12, 2018

Company Drug/Device Medical Condition Status
AVEO Oncology Tivozanib Highly refractory advanced or metastatic renal cell carcinoma (RCC) Met its primary endpoint of demonstrating a statistically significant benefit in
progression-free survival (PFS) in Phase III clinical trial
Fortis Therapeutics, Inc. FOR46 Metastatic castration-resistant prostate cancer and late-stage multiple myeloma The FDA has cleared two Investigational New Drug (IND) applications
Shoulder Innovations InSet Humeral Short Stem System Degenerative, rheumatoid or traumatic arthritis in the shoulder Received 510(k) clearance from the FDA
Eli Lilly Trulicity (dulaglutide) Heart attacks and stroke in type 2 diabetes Reduced major adverse cardiovascular events (MACE) in REWIND Phase III clinical trial
Themis Bioscience MV-CHIK Chikungunya fever Primary endpoint —neutralizing antibodies after one or two injections — was met in Phase II clinical trial
Bristol-Myers Squibb Empliciti (elotuzumab) Multiple myeloma in adults
who have received at least
two prior therapies
Granted approval by the FDA
Bone Therapeutics PREOB Hip osteonecrosis (ON) Halted Phase III trial after interim analysis showed it would not meet endpoints
Endo International plc Collagenase clostridium histolyticum (CCH) Cellulite Positive results announced from two identical Phase III RELEASE* clinical trials
Mallinckrodt plc H.P. Acthar Gel Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU) First patient screened in company’s Phase IV, multi-center, multiple-dose, open label trial to assess effect
OncoSec Medical TAVO™ (in combination with Merck’s KEYTRUDA®) Late-stage triple negative breast cancer (TNBC) First patient treated in KEYNOTE-890 Phase II clinical trial
Glenmark Pharmaceuticals CD38xCD3 bispecific antibody GBR 1342 Solid tumors Launching a Phase I
clinical trial
Drug-Coated Balloon (DCB) IDE
Narrowed or obstructed
arteries below the knee
Primary safety and efficacy endpoints were met in
Phase I clinical trial
Urovant Sciences, Inc. Vibegron Overactive bladder Completed enrollment in international Phase III clinical trial, EMPOWUR to evaluating safety and efficacy