Medical Tidbits, Health Canada Approves PrORKAMBI(R) (lumacaftor/ivacaftor) – the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved PrORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test.  read more

Baxter initiates Voluntary Nationwide Recall of Select Lots of IV Solutions Due to the Potential for Leaking Containers and Particulate Matter

Baxter International Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date. read more

Boehringer Ingelheim’s Giotrif® (afatinib) demonstrated superiority to gefitinib in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer

BRACKNELL, England–(EON: Enhanced Online News)–Boehringer Ingelheim announced today the results of the LUX-Lung 7 trial. Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib, versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). 1 The Phase IIb trial met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start, and discontinuation of treatment for any reason). 1 The LUX-Lung 7 trial results will be presented today at the 14th Annual British Thoracic Oncology Group (BTOG) Conference in Dublin, Ireland. Data for the third co-primary endpoint, overall survival (OS), are not yet mature and will be presented in the future. read more

Ferring Pharmaceuticals and Karolinska Institutet Sign Collaboration Agreement on the Development of a Human Microbiome Translational Research Programme

SAINT-PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals and Karolinska Institutet announce today that a collaboration agreement has been signed for the establishment of a research center exploiting the human microbiome. The programme will be fully funded by Ferring Pharmaceuticals and governed by a joint steering committee. read more

NTCELL® Continues to Reverse the Progression of Parkinson’s Disease – One Year after Implant

SYDNEY & AUCKLAND, New Zealand–(BUSINESS WIRE)–Over a year after treatment all four patients who took part in Living Cell Technologies Limited’s Phase I/IIa clinical study of NTCELL® for Parkinson’s disease remain well, and at 58 weeks post-implant there are no safety concerns. read more

ImmunoCellular Therapeutics Enters into a Sponsored Research Agreement with The University of Maryland, Baltimore to Pursue Multiple Enhancements of its Cancer Immunotherapy Platforms

/PRNewswire/ — ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) today announced it has entered into a sponsored research agreement with Eduardo Davila, PhD, Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, and the University of Maryland, Baltimore.  The agreement includes three projects, which together have the potential to improve the efficacy of dendritic cell, T-cell, and combination immunotherapies for cancer and lead to enhancements to both of ImmunoCellular’s dendritic cell and Stem-to-T-cell platforms. read more

Record Number of Irish Companies Showcase Medtech at Arab Health 2016

Irish company Fleming Medical signs $1 million distribution agreement with UAEs City Pharmacy

Enterprise Ireland Middle East, the regional arm of the Irish government organisation responsible for the development and growth of Irish enterprises in world markets, marks its fifth year at Arab Health with a significant increase in the number of healthcare companies under its umbrella.

Ireland is renowned as a global hub for healthcare excellence and in 2011 healthcare companies made up 10 percent of Enterprise Ireland’s total exporters in the Middle East & North Africa region – a figure that is expected to reach 30 percent by the end of 2016.

Journal of Clinical Oncology Publishes Results from the STRIVE trial of enzalutamide Compared to bicalutamide in Castration-resistant Prostate Cancer

/PRNewswire/ — Astellas US LLC, a United States (U.S.) subsidiary of Tokyo-based Astellas Pharma Inc. (TSE: 4503), and Medivation, Inc. (Nasdaq: MDVN) today announced that results from the STRIVE trial of enzalutamide compared to bicalutamide in men with castration-resistant prostate cancer (CRPC) were published in the Journal of Clinical Oncology.  The article, titled, “Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial,” appears in the January 25, 2016 online issue and will be published in a future print issue of the journal. read more


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