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/
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/
Dune Medical Devices, Inc., announced today that its breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System, has received Premarket Approval (PMA) by the United States Food and Drug Administration. The technology significantly improves surgeons’ ability to intra-operatively identify
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
Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease.
With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after drug elution is complete at three months.
The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.
To view the multimedia release go to:
http://www.multivu.com/players/English/7223456-boston-scientific-fda-approval-synergy/
At the heart of Ketel One Vodka lies one family’s unwavering passion for crafting the world’s finest spirits. Inspired by over 325 years of distilling expertise, the Nolet family brings old-world pot still craft and modern distilling techniques together in one flawless process. From Joannes to Jacobus to Carolus Sr., creator of Ketel One Vodka, to Carolus Jr. and Bob Nolet today, each of the 11 generations of Nolet family distillers is tasked with upholding a legacy of distilling excellence. Some may consider the Nolets a little obsessive, but those individuals just don’t understand. Everything must be done with meticulous attention to detail, because the family name is riding on every bottle of Ketel One Vodka.
“We take our work very seriously, not ourselves,” said Carl Nolet Jr., 11th Generation Nolet Family Distillery. “The stories we tell are all true and based on family events, beliefs and the pressure of upholding 11 generations of legacy for generations to come.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7975151-ketel-one-vodka
Today, Novo Nordisk announced new phase 3 interim data from its guardianTM2 trial for its recombinant coagulation factor VIII (rFVIII) product NovoEight® (turoctocog alfa), the first new rFVIII molecule in over a decade, which shows that it provides long-term reduction from bleeding in people with haemophilia A when used as a preventative treatment.1 The results were presented at the World Federation of Haemophilia (WFH) World Congress and support findings from other studies within the guardianTM clinical programme that found NovoEight® demonstrated good efficacy in preventing and treating bleeds without inhibitor development in previously treated patients.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/71400529-novoeight-reduction-of-bleeding-haemophilia-a
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
InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused Ultrasound therapy, announced that the U.S. Food and Drug Administration (FDA) has approved ExAblate® MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56632-insightec-fda-approves-exablate
