Pharma News

Pfizer Inc. announced the publication of a new post-hoc analysis of data from three studies of VYNDAQEL in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients with the Val30Met mutation treated over varying periods of up to 5.5 years, showed that treatment with VYNDAQEL initiated during the early stage of the disease resulted in minimal neurological disease progression and in preservation of body weight, which often declines as the disease progresses. VYNDAQEL was well tolerated with no new safety signals observed.

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. 

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).