Industry News

- Read more about Masimo receives CE Marking for pediatric O3 regional oximetry
Masimo announced the CE marking for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.
- Read more about Allergan, Richter provide update on clinical study of cariprazine
Allergan plc, a leading global pharmaceutical company, and Gedeon Richter Plc. provided a clinical and regulatory update on cariprazine. For more than a decade both companies have conducted over 20 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for patients suffering from a broad range of mental health illnesses.

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- Read more about U.S. FDA Filing Accept NDA for Merck’s MK-1293
Merck , known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.
- Read more about Quest Diagnostics Launches CogniSense, New Digital Dementia Assessment Test
Quest Diagnostics announced CogniSense™, a digital cognitive assessment tool that aids in a physician's assessment, diagnosis and care management of individuals with cognitive dysfunction. CogniSense is designed to overcome several limitations of conventional paper-based cognitive assessment, such as lack of objective, easily trackable data over time and integration to electronic health records (EHRs).
- Read more about FDA Approves Merck’s KEYTRUDA for Patients with Recurrent or Metastatic HNSCC
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
- Read more about EndoChoice Receives FDA Clearance for Lumos with Adaptive Matrix Imaging
EndoChoice Holdings, Inc. announced the recent FDA clearance and US launch of Lumos™ with Adaptive Matrix Imaging. This novel and proprietary imaging software system will now be part of the Company's Generation 3 Fuse® Full Spectrum Endoscopy® System.
- Read more about Sylogent launch PROJECTIC, an information management tool for pharma industry
Sylogent, a software and data services company, has announced the formal launch of PROJECTIC for the pharmaceutical industry. The web-based process management tool is designed to visualize milestones, projects and tasks across the enterprise with the push of a button. PROJECTIC is a flexible tool that allows for repetitive structured processes to be saved as templates that are managed by key data points.
- Read more about Quest Diagnostics and AncestryDNA team up to expand consumer DNA testing
Quest Diagnostics are teaming up to help meet the rapidly growing consumer demand for genetic tests that provide insights into genetic ethnicity, origins and other factors. The new collaboration will allow AncestryDNA to scale its testing services and pave the way for new wellness offerings.
5 August 2016

Microbion’s MBN-101 receive Fast Track designation

Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, specializing in the treatment of hard to treat and antibiotic-resistant infections, announced that the U.S. FDA has granted MBN-101 Fast Track designation for adjunctive treatment of mild and moderate diabetic foot ulcer infections.
- Read more about GSK & Google's Verily to develop bioelectronic medicines
GSK agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to enable the research, development and commercialisation of bioelectronic medicines. GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%.