Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report, “A Decade of Innovation in Rare Diseases,” to document the significant progress made in the last 10 years in understanding a broad range of rare diseases and translating this knowledge into groundbreaking therapies for a variety of patient populations.
The report illustrates that more than 230 new medicines to treat rare or “orphan” diseases were approved by the U.S. Food and Drug Administration (FDA) in the last decade, and there are currently more than 450 orphan drugs in development.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7350554-phrma-report-innovation-rare-diseases/
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval and launch of the Cochlear™ Nucleus® Hybrid Implant System, a revolutionary new hybrid hearing solution that helps people who may hear a little but are still missing a lot, even with their hearing aids. The Nucleus Hybrid System is a unique combination of proven solutions, which allows people to get back what they've been missing by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they've lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the Nucleus Hybrid System will allow them to maximize their hearing in all frequencies.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7150651-cochlear-fda-approval-u-s-launch-cochlear-nucleus-hybrid-implant-system
Nearly 12 million men in the U.S. suffer from symptoms related to benign prostatic hyperplasia (BPH), an enlargement of the prostate that can cause issues such as frequent and weak urinary streams and sleep deprivation from getting up repeatedly during the night to urinate. Since traditional BPH therapies such as daily medications and more invasive or surgical procedures often result in unwanted side effects and complications, more than 54 percent of men who would benefit from treating their BPH choose not to do anything1. With today’s national introduction of the FDA-cleared Rezūm® System, NxThera provides urologists and their patients suffering from symptomatic BPH with a new, safe and effective minimally-invasive, office-based treatment option which improves quality of life and preserves sexual function2 – one of the main reasons many men choose to forego medications or more invasive procedures.
“Men suffering from BPH are constantly evaluating the trade-offs between maintaining their current declined quality of life or treating their BPH symptoms and possibly incurring long term side effects,” said Dr. Kia Michel, M.D., a urologist at Comprehensive Urology in Los Angeles who recently performed the procedure as part of a nationally televised segment on prostate health. “Of all the minimally-invasive BPH treatments I’ve performed, Rezūm is the most effective and most versatile treatment available to patients – and the results have been excellent.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7933151-nxthera-rezum-therapy/
The egg has been associated with festivals celebrating spring for many centuries. Decorating eggs for Easter is a tradition that dates back to the 13th century or earlier. Eggs were formerly a forbidden food during the Lenten season, and there are rituals in many countries involving painting and decorating them to mark the end of the period of penance and fasting, and then eating them as a celebration of Easter.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54146-u-s-fda-playing-it-safe-with-eggs-food-safety-tips
ACCU-CHEK Aviva Expert offers people with diabetes a new and easy way to simplify complex calculations to deliver precise insulin dosing advice.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the ACCU-CHEK® Aviva Expert system, the first and only blood glucose meter system with a built-in insulin calculator to be approved by the U.S. Food and Drug Administration (FDA), is now available by prescription. The device represents a significant advancement in blood glucose meter technology for people with diabetes who take multiple daily insulin injections. The meter’s integrated bolus calculator provides easy-to-use and reliable dose recommendations based on automated calculations, eliminating the need for manual dosing calculations and estimations.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7322751-roche-accu-chek-aviva-expert-blood-glucose-meter-now-available/
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of Fluzone® (Influenza Vaccine) for the 2016-2017 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA) for shipment. This represents the first of more than 65 million total doses of seasonal influenza vaccine manufactured by Sanofi Pasteur that will be delivered to U.S. health care providers and pharmacies beginning in July and continuing throughout the remainder of the year. Sanofi Pasteur plans to increase its supply to respond to the shifting pediatric public health needs.
Seasonal influenza activity typically occurs between October and May and peaks between December and February. However, influenza activity peaked noticeably late last season occurring in early March 2016.1 Influenza seasons are always unpredictable as new influenza strains emerge and strain activity fluctuates throughout the year, making timely vaccination even more important to help protect against the virus, especially for seniors, young children and infants six months of age and older.
To view the multimedia release go to:
http://www.multivu.com/players/English/7842051-sanofi-pasteur-influenza-vaccine/
FDA’s Read the Label Youth Outreach Campaign is an exciting initiative that challenges kids (ages 9 to 13) to “get their food facts first” by using the Nutrition Facts Label to make healthy food choices. Read the Label campaign materials enable parents and caregivers to help kids use this important tool.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7106352-fda-read-the-label-youth-outreach-campaign-tweens-healthy-choices
Summer has arrived – and now is the perfect time to enjoy fresh fruits and vegetables from the farm stand, supermarket, or even your own garden! The U.S. Food and Drug Administration reminds you that safe handling of produce and fresh-squeezed juice is especially important during the summer months, because foodborne bacteria multiply faster in warm weather and fresh fruits and vegetables are often consumed raw.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7231952-fda-produce-safety/
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
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the ClearSight system.
The ClearSight system is a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
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/
Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved the Tecnis Symfony® Intraocular Lenses for the treatment of cataracts. The first in a new category of intraocular lenses (IOLs), the Tecnis Symfony lenses are the only lenses in the United States that provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.
Cataracts are a common condition, with almost 4 million cataract surgeries performed each year, and that number is expected to increase.1 By age 80, more than half of all Americans either have a cataract or have had cataract surgery.2 However, cataracts do not just impact seniors. In 2016 it is estimated that nearly one in four cataract surgeries will be performed on people younger than 65.1 Many people who have cataracts experience other problems with their vision, such as presbyopia and astigmatism, which the Symfony lenses also address. Presbyopia, which affects most people over age 40, means people have lost the ability to focus on objects up close and often require glasses to perform near visual tasks. Astigmatism is when the cornea is misshapen, which causes blurry or distorted vision.
To view the multimedia release go to:
http://www.multivu.com/players/English/7870151-abbott-intraocular-lenses/
