Clinical Trials

Merck’s BELSOMRA C-IV meets primary efficacy endpoint in phase 3 trial

Merck announced the presentation of results of a phase 3 trial evaluating the efficacy and safety of BELSOMRA (suvorexant) C-IV for the treatment of insomnia in people with mild-to-moderate Alzheimer’s disease dementia.

Xencor begins phase 1 trial of XmAb23104 in advanced solid tumors

Xencor has dosed the first patient in a phase 1 clinical trial that will evaluate its bispecific antibody XmAb23104 for the treatment of advanced solid tumors.

AstraZeneca’s blood cancer drug Calquence improves PFS in phase III Ascend trial

AstraZeneca announced that its blood cancer drug Calquence (acalabrutinib) has met its primary endpoint at interim analysis in the phase III Ascend (ACE-CL-309) trial.

PharmaCyte Biotech advances manufacturing process for clinical trial in pancreatic cancer

PharmaCyte Biotech, a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced that advances have been completed in the manufacturing process for the clinical trial product that will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Pear Therapeutics initiates feasibility study to treat depressive symptoms in people with multiple sclerosis

Pear Therapeutics, Inc. announced the start of a feasibility study for a prescription digital therapeutic (PDT) intended to treat depressive symptoms in people with Multiple Sclerosis (MS). Known as Pear-006, the PDT is intended to be used in combination with disease-modifying treatment.

WuXi AppTec buys clinical research services firm Pharmapace

WuXi AppTec has acquired US-based clinical research services firm, Pharmapace, for an undisclosed sum.

GSK, Innoviva’s Trelegy Ellipta meets primary endpoint in phase III asthma study

GlaxoSmithKline (GSK) and Innoviva’s respiratory drug Trelegy Ellipta has met primary endpoint in the phase III CAPTAIN (clinical study of asthma patients receiving triple therapy through a single inhaler) study.

Exelixis initiates phase 3 trial of cabozantinib in advanced renal cell carcinoma

Exelixis, Inc. today announced that it is initiating COSMIC-313, a phase 3 pivotal trial of cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.

Navidea announces comparative study to evaluate tilmanocept in patients with TB

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Professor Mike Sathekge, MBChB, M. Med (Nuclear Medicine), PhD Professor and Head of the Department of Nuclear Medicine in the Faculty of Health Sciences at the University of Pretoria/Steve Biko Academic Hospital, plans to initiate a comparative study evaluating the use of Tilmanocept in patients with TB.