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New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.
In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.
“This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news
7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning.
1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical Source Type: news
Making Sense of Nutraceuticals in China
The Chinese nutraceutical market is considered the third largest in the world after the US and Japan, or the fourth largest if Europe is counted as a single market.Despite strong fundamentals and high rates of annual growth, though, the Chinese market remains some way from realizing its true potential. Its evolution is muddied by ambiguities around what nutraceuticals actually are and how they should be managed.The result has been polarization between over-zealous regulation of so-called health foods, and a grey market where products have skirted approval procedures through questionable positioning or by exploiting alterna...
Source: EyeForPharma - February 10, 2017 Category: Pharmaceuticals Authors: Marc Yates Source Type: news
Pretty Much Nobody In The U.S. Leads A Healthy Lifestyle
Only 2.7 percent of U.S. adults hit the four key metrics of living a healthy lifestyle -- abstaining from smoking, eating well, exercising and maintaining a healthy body fat percentage -- according to a disheartening new study. The study's lifestyle benchmarks for health weren't particularly high. Being smoke-free, exercising moderately and eating USDA recommended foods don't seem like particularly difficult marks to hit. So why do so many Americans fall short of living healthy lives? "That is the million dollar question," Ellen Smit, a senior author of the study and an associate professor at the Oregon State Un...
Source: Science - The Huffington Post - March 25, 2016 Category: Science Source Type: news
No, Omega 3-Enriched Beef Is Not Necessarily Heart Healthy
Feeding cattle flaxseed or marine algae can raise the omega-3 fatty acid levels in ground beef from 30 milligrams per serving to 200 milligrams per serving, as Kansas State University researchers have found. But do higher levels of omega-3s make red meat significantly healthier? Not according to Kim Larson, a registered dietitian nutritionist and spokesperson for the Academy of Nutrition and Dietetics. The attempt to make beef look like an important source of omega-3s is essentially a marketing ploy, she said. And despite the fatty acid's reputation as a health ...
Source: Science - The Huffington Post - October 14, 2015 Category: Science Source Type: news
