Intec Pharma Ltd, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the initiation of a new clinical development programme for its Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa.
The China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate (eribulin, product name: Halaven) for use in the treatment of patients with locally advanced or metastatic breast cancer in China.
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.
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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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.
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).
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.
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.
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.
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.
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