An injury ends Laura Nelson’s career as a surgeon. Now, as Vice President of a pharmaceutical company, Laura works to finalize the approval of a groundbreaking new drug. But her efforts are being thwarted by a malicious FDA employee who will stop at nothing to prevent the approval, and Laura is standing directly in his path. Find out more about the author here- http://patriciagussin.com/ and check out the book here http://oceanviewpub.com/after-the-fall/. After the Fall by Patricia Gussin. Thriller
Following FDA approval of the AspireSR® generator for the VNS Therapy® system in June 2015, more than a thousand patients with drug-resistant epilepsy across the United States have received this new treatment option. Many of these patients are experiencing benefits which have positively impacted their lives – and are sharing their stories during Epilepsy Awareness Month with the hope of encouraging others to seek new treatments for drug-resistant epilepsy. Numerous hospitals nationwide have begun providing the AspireSR device to patients with drug-resistant epilepsy – a condition that affects as many as one-third of people with epilepsy, causing them to have seizures in spite of treatment with antiepileptic medications.
The VNS Therapy system is a minimally invasive option in which a medical device is placed under the skin in the upper chest area during an outpatient procedure. The device sends mild electrical pulses through the vagus nerve to areas of the brain known to be associated with seizures. The new AspireSR generator takes the VNS Therapy technology a step further – detecting relative heart-rate increases that are often associated with seizures in people with epilepsy and providing responsive stimulation in an attempt to stop and shorten seizures and improve recovery.
To view the multimedia release go to:
http://www.multivu.com/players/English/7651751-livanova-aspiresr-treatment/
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among people previously at low risk for the disease. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDA-approved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD.
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/optimerpharma/50177/
Gen-Probe (NASDAQ: GPRO) announced today the US Food and Drug Administration (FDA) has approved its PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.
To view Multimedia News Release, go to http://www.multivu.com/mnr/53530-gen-probe-progensa-pca3-prostate-cancer-psa
Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7092251-fda-approve-s-exact-sciences-cologuard-screening-test-colorectal-cancer/
1 in 3 women will notice hair thinning in her lifetime, and it can start as early as her 20’s. Today, the hair regrowth category leader, ROGAINE® Brand, announced the official launch to market of Women's ROGAINE® 5% Minoxidil Topical Aerosol, the first and only FDA-approved, once-daily use treatment for Female Pattern Hair Loss containing 5 percent minoxidil in an elegant foam formula. Minoxidil is the only topical ingredient FDA-approved to help regrow hair.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7368851-introducing-women-s-rogaine-5-percent-minoxidil-topical-aerosol-fda-approved/
Boston Scientific Corporation (NYSE:BSX) announces U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the Company’s next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug. The Company plans to begin marketing the product in the U.S. immediately.
To view Multimedia News Release, go to http://www.multivu.com/mnr/43510-boston-scientific-fda-promus-element-plus-platinum-chromium-stent-system
Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO◊ system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures. This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.
To view Multimedia News Release, go to http://www.multivu.com/mnr/51011-smith-nephew-pico-system-fda-approval-npwt
Como preparación para el 4 julio y los meses veraniegos, período en el cual aumentan los casos de intoxicación alimentaria, el Ad Council y el Servicio de Inocuidad e Inspección de los Alimentos del Departamento de Agricultura de los Estados Unidos, en asociación con la Administración de Alimentos y Medicinas de los Estados Unidos (FDA) y los Centros para el Control y la Prevención de Enfermedades (CDC), prosiguen con su campaña de servicio público Familias Preparando Alimentos Adecuadamente a nivel nacional, el primer esfuerzo en multimedios diseñado para aumentar el grado de conciencia sobre los riesgos de las enfermedades transmitidas por los alimentos (o intoxicación alimentaria) en el hogar. Nuevos anuncios de servicio público (PSA), colocados en vallas, marquesinas de autobuses y otras localidades en exteriores a lo largo y ancho del país, están siendo distribuidos a medios informativos de todo el país y el spot televisivo “Chill” (Refrigere) se transmitirá a través de la cadena Checkout TV Network en 600 en tiendas de Walmart a nivel nacional.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56942-ad-council-usda-hhs-food-safe-families-public-service-campaign
Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61338-raptor-pharmaceutical-procysbi-fda-approval-nephropathic-cystinosis
In recognition of Melanoma Monday® and National Melanoma/Skin Cancer Detection & Prevention MonthTM, MELA Sciences, Inc. (NASDAQ: MELA) visited the NASDAQ MarketSite in Times Square today to ring the Opening Bell and sponsor free skin cancer checks.
One American dies every hour from melanoma, the most deadly skin cancer. MELA Sciences, Inc. is the pioneer company behind MelaFind®, the first and only FDA-approved diagnostic tool that helps dermatologists detect melanoma at its most curable stage. MelaFind® was approved by the U.S. Food & Drug Administration (FDA) in Fall 2011, and since then has strategically rolled out the technology to dermatology practices across the country.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61584-mela-sciences-rings-opening-bell-awareness-melanoma-detection-prevention
With their high quality protein and other essential nutrients, fish and shellfish are important parts of a healthful diet. But, as with any food, safe handling is essential to reducing the risk of foodborne illness, often called “food poisoning.” Follow these basic food safety tips for buying, storing, and preparing fish and shellfish.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/54147-u-s-fda-safe-food-handling-tips-fish-shellfish-reduce-risk-food-poisoning
