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
In recent years there has been a shift in the understanding of cancer. Immunotherapy with vaccines has been emerging as the most promising direction towards a decisive improvement of treatment outcomes.
The Dendritic Cell Vaccine has received FDA approval for prostate cancer and trials are now under way for a variety of other cancers. These vaccines are usually administered on their own.
To view Multimedia News Release, go to http://www.multivu.com/mnr/64654-issels-integrative-immunotherapy-for-standard-therapy-resistant-cancers
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today it has received U.S. Food and Drug Administration (FDA) approval for its newest innovative hearing loss solution, Kanso.
The Kanso Sound Processor provides a distinct new way for cochlear implant users to hear. Unlike most hearing aids and current cochlear implant sound processors that are worn on the ear, Kanso is a small, off-the-ear hearing device that provides a more discreet hearing solution and delivers the same hearing experience as a behind-the-ear sound processor.
The name Kanso is a Japanese word for ‘simplicity,’ and it was selected in recognition of Kanso’s all-in-one design. The Kanso Sound Processor features a single on/off button with no cables so it is easy to use. It is worn on the user’s head with nothing behind the ear, adding greater comfort for those with glasses, and it can be easily hidden under or blended within a user’s hair.
To view the multimedia release go to:
http://www.multivu.com/players/English/7658352-cochlear-kanso-fda-approval/
The millions of women who experience bladder leakage now have a new option to strengthen and tone away their problem instead of covering it up with pads.
The PeriCoach System is a discreet device and smartphone app that helps women perform at-home pelvic floor muscle training, exercises recommended by the American College of Physicians as first-line treatment for urinary incontinence. PeriCoach is the only system that includes a web portal allowing clinicians to remotely monitor their patients’ progress.
To view the Multimedia News Release, go http://www.multivu.com/players/English/7543451-pericoach-fda-approval/
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/
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/
EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device/
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The following is being released by the Notice Provider, Kinsella Media, LLC, about the lawsuit In re Automotive Parts Antitrust Litigation, MDL No. 2311.
There is an update for affected purchasers in this lawsuit about certain vehicle components, as there have been additional Settlements that may affect their rights.
Twelve additional Defendants have agreed to Settlements resolving claims that they fixed the price of certain vehicle components. (The Court previously approved settlements with 11 Defendants, totaling approximately $225 million.) The additional Settlements being presented for Court Approval total approximately $379 million.
The lawsuits allege that Defendants fixed the price of certain vehicle components, causing millions of consumers and businesses from around the country to pay more for certain new or leased vehicles and replacement parts. A complete list of included parts is available at the website, www.AutoPartsClass.com.
To view the multimedia release go to:
http://www.multivu.com/players/English/7982351-auto-parts-class-action-settlements/
