Merck, referred to as MSD outside the US and Canada, and Luminex have signed a deal to develop a companion diagnostic device to support patient selection for the clinical development program of investigational drug MK-8931 to treat ...
Tags: companion diagnostic device, drug, Merck
Target Health and LifeOnKey have own Israel-United States Binational Industrial Research and Development (BIRD) Foundation award to integrate the EMR with the electronic data capture (EDC) clinical trial database. The two-year award worth ...
Tags: Health, LifeOnKey, clinical trial
St. Jude Medical has implanted the first patient in a clinical study of its Amplatzer Cardiac Plug (ACP) device, designed for the prevention of stroke in patients with non-valvular atrial fibrillation (AF). The self-expanding occlusion ...
Tags: St.Jude Medical, clinical study, ACP device
Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
CMS Medical, a distributor and manufacturer of minimally-invasive medical products in Brazil, has entered into a collaboration agreement with GI Dynamics. Under the deal, CMS will distribute GI Dynamics' EndoBarrier therapy in Brazil, ...
Swedish medical device company Dignitana's subsidiary Brain Cool has announced that its medical brain cooling system is being tested in a Phase One clinical trial at the University of Edinburgh. The Brain Cool system, which uses a ...
On-X Life Technologies has gained US marketing rights to its new On-X aortic prosthetic valve with anatomic sewing ring, following the regulatory approval from the US Food and Drug Administration (FDA). The prosthetic valve, which is made ...
Global diagnostic imaging network AG Mednet has launched a Cloud Storage Solution with on-demand access to clinical trial data. AG Mednet Storage complements the firm's other software, including AG Mednet Submission Quality & Compliance, ...
Tags: clinical trial, Cloud Storage Solution, clinical trials
Contract development and manufacturing company Pharmatek is all set to expand its good manufacturing practice (GMP) facilities, owing to increasing growth and global demand for its services. The expansion, which is expected to complete in ...
Tags: Pharmatek, Packaging Capabilities, Packaging
ReShape Medical has completed patient enrollment in a pivotal clinical trial of its ReShape Duo Intragastric Balloon device, designed for the treatment of obese. Using a standard endoscope, non-surgical weight loss device is placed in the ...
Tags: ReShape, weight loss device, Medical
Ventrix said that its VentriGel biomaterial scaffold has shown potential to prevent heart failure following heart attack in a pre-clinical study. VentriGel is injected in a minimally-invasive procedure using a catheter to repair damaged ...
Tags: Ventrix, heart attack, minimally invasive
Neurim Pharmaceuticals has announced positive results from a phase II clinical study reviewing the efficacy and safety of piromelatine. The novel investigational multimodal sleep medicine has been developed for the treatment of patients ...
Tags: Neurim Pharmaceuticals, positive results, phase II clinical study
Exact Sciences has submitted the second module of premarket application (PMA) of its noninvasive stool DNA colorectal cancer screening test to the US Food and Drug Administration (FDA). The module included the required studies and ...
Tags: FDA, colorectal cancer, clinical trial
Critical Pharmaceuticals has completed second clinical trial on CP024 intranasal growth hormone. CP024 growth hormone nasal spray was safe and well tolerated in the study that administered six dose levels of CP024 in healthy subjects. ...
K&L Consulting Services, a contract research organization for clinical trial Sponsors, has chosen OpenClinica's Enterprise Edition for Electronic Data Capture (EDC) and clinical data management to implement in its Phase I-IV clinical ...
Tags: K&L Consulting Services, clinical trial Sponsors, OpenClinica, EDC