Pharma News

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. 

Dynavax Technologies Corporation  announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.

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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The parasites responsible for malaria and toxoplasmosis depend on mechanisms inherited from the plant world. This is what a team of researchers from CNRS and the University of Melbourne has shown. They have just published two studies in Cell Microbiology and PLOS Pathogens. This discovery is a major advance for the development of new therapeutic targets for these parasites, which have such substantial public health consequences. 

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.