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/
Cancer Treatment Centers of America® (CTCA), a national network of comprehensive cancer care hospitals and outpatient care centers, and Foundation Medicine, a leading molecular insights company that recently received FDA approval for its FoundationOne CDx™ genomic test, today announced the launch of a collaborative educational campaign designed to heighten awareness of the promise of precision medicine and the role that advanced genomic testing plays in helping identify treatments best suited for individual patients.
To view the multimedia release go to:
https://www.multivu.com/players/English/8295651-cancer-treatment-centers-of-america-foundation-medicine-precision-cancer-treatment/
Global biotherapeutics leader CSL Behring today announced that results were published in the New England Journal of Medicine (NEJM) from the COMPACT study, a pivotal Phase III study evaluating the safety and efficacy of CSL830 (a novel, investigational, self-administered, subcutaneous C1-Esterase Inhibitor [C1-INH] Human replacement therapy) for the prevention of HAE attacks. The study met its primary efficacy endpoint, significantly reducing the time-normalized number of HAE attacks. In addition, the study met its secondary endpoints, including the responder rate (patients who had at least a 50% reduction in their attack rate) and the number of rescue medication uses. If approved by the FDA, CSL830 would be the first and only subcutaneous preventative therapy for HAE.
To view the multimedia release go to:
https://www.multivu.com/players/English/8056151-csl-behring-subcutaneous-c1-esterase-inhibitor-hae-patients/
Studies show that more than two-thirds of aesthetically-oriented consumers are bothered by submental fullness, or “double chin.” And with social media profile images becoming more important than ever, there is interest in looking one’s best.
Submental fullness due to fat beneath the chin can impact a broad range of both men and women and because the condition can be genetic and resistant to diet and exercise. But there’s KYBELLA®, the first and only FDA-approved injectable treatment that is available by prescription only, that has been proven to improve the appearance of moderate to severe fat beneath the chin by physically destroying fat cells in the treatment area. In two pivotal clinical studies for KYBELLA®, reductions in submental fat volume were observed more frequently in the KYBELLA® treated group of 514 patients compared to the placebo group (508 patients) as measured by both clinician and patient ratings. In addition, visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were evaluated using a 6-question survey and 79% of 1 and 2-grade composite responders reported satisfaction after 12 weeks post final treatment compared with 33.6% of patients who received placebo.
To view the multimedia release go to:
http://www.multivu.com/players/English/7962051-kybella-injectable-double-chin-treatment-campaign/
The Eeva Test is now commercially available in the United States following its recent FDA clearance. This breakthrough technology is designed to help fertility clinics select the best embryos during in vitro fertilization (IVF) to aid in their effort to provide the best chance of a successful pregnancy.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7415751-the-eeva-test-by-auxogyn/
A first-of-a-kind neural stem cell therapy that works with a common cold virus to seek out and attack a lethal and aggressive brain cancer is being tested at Northwestern Medicine in a Phase I clinical trial for patients newly diagnosed with malignant glioma.
The novel drug to treat malignant glioma, notorious for recurring after typical bouts of standard cancer treatment, was developed by a Northwestern scientist and has been approved as an investigational drug by the U.S. Food and Drug Administration. This is only the second time the University has supported and filed an investigational new drug as a sponsor.
To view the multimedia release go to:
https://www.multivu.com/players/English/7944251-northwestern-medicine-stem-cell-trial/
The winter of 2016-2017 is in its early stages, and yet many parts of the country are already experiencing extreme weather conditions and power outages. In fact, a power outage can happen at any time, and it can affect the safety of your food. The U.S. Food and Drug Administration reminds you that the best way to ensure that food stays safe is to have a plan in place, and to know what food safety precautions to take if a power outage does occur.
To view the multimedia release go to:
http://www.multivu.com/players/English/7876851-fda-power-outage-food-safety-2016/
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, introduces today its latest innovation, the Cochlear™ Nucleus® 7 Sound Processor. Approved by the U.S. Food and Drug Administration (FDA) in June, the Nucleus 7 Sound Processor is the world’s first Made for iPhone cochlear implant sound processor and the smallest and lightest behind-the-ear cochlear implant sound processor available on the market.1-3
With the Nucleus 7 Sound Processor, people with a Cochlear Nucleus Implant can now stream sound directly from a compatible iPhone, iPad and iPod touch directly to their sound processor.4,5* They will also be able to control, monitor and customize their hearing on their iPhone or iPod touch through the Nucleus® Smart App available to download for free from the App Store®.
To view the multimedia release go to:
https://www.multivu.com/players/English/7987851-cochlear-nucleus-7-sound-processor/
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) alerta a las mujeres embarazadas sobre los riesgos de la listeriosis, una enfermedad transmitida por los alimentos que puede afectar gravemente a las mujeres embarazadas y a sus bebés no nacidos.
La Listeria puede afectar a personas de todas las razas y grupos étnicos, pero las mujeres embarazadas tienen una probabilidad aproximadamente 10 veces mayor de contraer listeriosis que otros adultos sanos debido a los cambios hormonales que afectan el sistema inmunológico durante el embarazo. Las mujeres hispanas embarazadas son unas 24 veces más propensas a contraer listeriosis que la población general. Una mujer embarazada puede transmitir la Listeria a su bebé no nacido incluso sin saberlo porque no se siente enferma, pero la enfermedad puede provocar un aborto espontáneo, muerte fetal, parto prematuro, nacimiento de un bebé con bajo peso, una amplia gama de problemas de salud para el recién nacido o incluso la muerte del bebé.
To view the multimedia release go to:
https://www.multivu.com/players/Spanish/7953451-fda-listeriosis-prevention-pregnant-women/
The winter of 2015-2016 is in its early stages, and yet many parts of the country are already experiencing extreme weather conditions and power outages. In fact, a power outage can happen at any time, and it can affect the safety of your food. The U.S. Food and Drug Administration reminds you that the best way to ensure that food stays safe is to have a plan in place, and to know what food safety precautions to take if a power outage does occur.
To view the multimedia release go to:
http://www.multivu.com/players/English/7674751-fda-power-outage-food-safety/
