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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/
Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already approved for closure of atrial septal defects (ASDs) up to 17 mm, is now also approved for the closure of PFO to reduce the risk of recurrent ischemic stroke in certain patients.*
To view the multimedia release go to:
https://www.multivu.com/players/English/8301551-gore-cardioform-septal-occluder-fda-approval/
Abbott today announced the U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children’s hearts. This dime-sized new valve is the first and only pediatric mechanical heart valve developed for newborns and infants, and offers hope for pediatric patients in urgent need of treatment who have no other approved options.
To view the multimedia release go to:
https://www.multivu.com/players/English/8280551-abbott-pediatric-heart-valve-fda-approval/
Federally funded research that provides a deep understanding of cancer is spurring advances against many types of the disease. With a strong bipartisan commitment from Congress to keep investment in biomedical research a national priority, we can accelerate our pace of progress and save more lives from cancer, according to the seventh annual American Association for Cancer Research (AACR) Cancer Progress Report, released today.
Basic research in the fields of immunology and cancer genetics has recently been harnessed to develop two new forms of cancer treatment: immunotherapy and precision medicine. As detailed in the report, the utility of these treatments is expanding rapidly. In May 2017, the U.S. Food and Drug Administration (FDA) heralded a new dawn for precision medicine when it approved the immunotherapeutic pembrolizumab (Keytruda) for treating patients with any solid tumor harboring specific genetic characteristics. This is the first anticancer therapeutic approved based on cancer biomarkers rather than the location in the body where the cancer originated.
To view the multimedia release go to:
https://www.multivu.com/players/English/8155051-aacr-cancer-progress-report-2017/
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/
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of the Fluzone® (Influenza Vaccine) portfolio for the 2017-2018 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA). Sanofi Pasteur has begun distributing initial shipments, representing the first of nearly 70 million total doses of seasonal influenza vaccine manufactured by the company for this upcoming influenza season. Widespread shipment of Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal Quadrivalent vaccine to health care provider offices, pharmacies and other immunizers will begin in early August to support fall immunization campaigns.
“As we enter the Swiftwater site’s 120th year, it reminds us of our innovation and growth as we came to understand the science of influenza and its impact on human health,” said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. “Influenza can be especially severe for the most vulnerable populations, including the elderly, young children and those with compromised immune systems; however, it can also have a serious health impact on otherwise healthy individuals. Sanofi Pasteur is and always has been deeply committed to improving public health by continuously striving to develop new vaccines and on improving existing ones.”
To view the multimedia release go to:
https://www.multivu.com/players/English/8081151-sanofi-pasteur-influenza-vaccine-first-shipment-2017/
Dornier MedTech® America, a global medical device company and the pioneer of Extracorporeal Shock Wave Lithotripsy (ESWL®), has received FDA clearance to market the Delta® III. This is the latest generation of the world’s best-selling and most clinically cited lithotripter, the Delta II.
To view the multimedia release go to:
https://www.multivu.com/players/English/8134451-dornier-medtech-delta-iii-kidney-stone-lithotripter/
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/
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 U.S. Food and Drug Administration (FDA) is alerting pregnant women about the risks of listeriosis, a foodborne disease that can severely affect a pregnant women and her unborn child.
Listeria can affect all races and ethnic groups, but pregnant women are 10 times more likely than other healthy adults to get listeriosis due to hormonal changes that affect the immune system during pregnancy. Pregnant Hispanic women are about 24 times more likely than the general population to get listeriosis. A pregnant mother may pass Listeria onto her unborn baby without even knowing it because she doesn’t feel sick at all, yet the disease can lead to miscarriage, stillbirth, premature labor, the delivery of a low birthweight infant, a wide range of health problems for a newborn, or even infant death.
To view the multimedia release go to:
https://www.multivu.com/players/English/7953451-fda-listeriosis-prevention-pregnant-women/
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/
