The Food and Drug Adminstration gave the green light for Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) for the treatment of pediatric patients 6 years old and older with active psoriatic arthritis.
This rare disease that resembles adult PsA affects 5% to 8% of children and adolescents with chronic inflammatory arthritis.
Two of the four indications for Stelara now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate to severe plaque psoriasis.
Stelara is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases. Stelara is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.
“We know active pediatric psoriatic arthritis is a challenging inflammatory disease given its rarity and that symptoms, such as swollen joints and skin lesions, can vary significantly in presentation and severity,” said Terence Rooney, vice president of rheumatology and maternal fetal disease area at Janssen Research & Development.
“With this pediatric approval of Stelara, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy,” he said.
“The approval of Stelara for use in children six years of age and older with active psoriatic arthritis, which follows the 2020 approval for moderate to severe plaque psoriasis in this population, is complemented by more than 12 years of clinical trial and real-world evidence across all approved indications demonstrating the safety and efficacy of this biologic therapy” said said Jennifer Davidson, vice president of immunology medical affairs at Janssen Scientific Affairs. “As a global leader in immunology, Janssen is dedicated to reducing the burden of chronic autoimmune diseases, and this additional approval for Stelara builds on our legacy of bringing important treatment options to younger patients.”
EnlivenHealth, the retail pharmacy solutions division of Omnicell, is releasing Amplicare Clinical Solution, a comprehensive suite of integrated technology solutions.
The automated technology suite is designed to enable pharmacies to shift from focusing primarily on dispensing medications to providing and efficiently billing for a growing array of high value clinical services, such as vaccinations, point-of-care testing and health-and-wellness counseling, the company said.
Amplicare noted that in the face of declining reimbursements and rising direct and indirect remuneration fees, as well as the persistent challenges of inefficient pharmacy workflows, many retail pharmacies have realized they need to transform both their clinical practices and business operations to continue to thrive and grow. At the same time, the COVID-19 pandemic has accelerated the trend of pharmacies becoming an increasingly central, and uniquely trusted, player in community health care, according to Amplicare.
EnlivenHealth’s Amplicare Clinical Solution is intended to provide a fully integrated and automated suite of technology solutions that should enable pharmacies to meet these growing challenges and capitalize on emerging opportunities to provide highly accessible and trusted healthcare services, the company said.
It is expected to enable pharmacies to become true clinical services providers by automating the process of identifying patient opportunities, providing appropriate clinical care and efficiently billing for those services, all in one integrated platform, according to the company.
“Retail pharmacy now finds itself at the epicenter of community health care,” said Danny Sanchez, senior vice president and general manager of EnlivenHealth.
“Our new Amplicare Clinical Solution was purpose-built to help pharmacies strengthen and expand that growing role, and was designed to keep patients healthy through medication adherence while enabling revenue-generating clinical services,” Sanchez said. “Our automated solutions suite should also help pharmacies reduce the administrative and operational burdens that keep pharmacists from practicing at the top of their license. We believe this really is a win-win for pharmacies, their patients and community health care overall.”
Key clinical services enabled by the EnlivenHealth Amplicare Clinical Solution include:
Clinical documentation and task management;
Care opportunities for intervention (i.e., vaccinations for COVID-19, flu, etc.);
Bio-Oil recently debuted a brand-new product — Bio-Oil Body Lotion.
Featuring a high-oil formula that is delivered in a nongreasy and ultralight fluid lotion, the product contains natural plant oils, vitamins and antioxidants, the company said.
Suitable for use on hands, arms and legs, the Bio-Oil Body Lotion is vegan, cruelty-free and comes in recyclable packaging.
Designed to spread easily, the lotion is quickly absorbed into the skin, contains 42% oil and does not leave behind a greasy residue. In addition, it also features a thin fluid-like consistency in which the water and oil are very lightly bound together, the company said.
It currently comes in an 8.5-oz. size that retails for $14.99 on Amazon and a 5.9-oz. size that retails for $11.99 on Amazon and for $15.99 at Ulta Beauty.
Cinnamon Toast Crunch is adding a hint of sweetness and heat to the breakfast aisle with its new CinnaFuego Toast Crunch.
The cereal, which combines sweet cinnamon and fiery spices including spicy pepper, looks the same as the original cereal, the brand said.
“CTC is always looking to give our fans the most absurd and exciting experiences,” said Mindy Murray, General Mills senior marketing communications manager. “So when we were thinking about what to do next, we realized snack time was a moment that could be spiced up. We can’t wait for CTC lovers to try CinnaFuego, and if they dare, eat it with some milk for breakfast.”
Sold in a resealable pouch, CinnaFuego Toast Crunch will be available on August 12 exclusively at Walmart.com for a limited time.
Clarvue releases advanced dark site management tool
Clarvue, a leading custom software solutions company, has launched a new dark site management tool to help retailers manage their closed locations.
The tool allows for asset tracking, risk management and mitigation, compliance, lease management, vendor management, and remote monitoring, as well as reduces the operation and financial burden of dark sites from time of announcement, until they are no longer part of the real estate portfolio.
“This rapidly changing retail environment has created a tremendous need for retailers to effectively and efficiently manage dark sites,” said Mike MacKenzie, president and founder of Clarvue.
“The majority of retail management tools are designed to open and operate new and/or existing sites, with very little attention to effective management of closures. There are substantial cost savings and efficiencies retailers can realize with our dark site management tool, and Clarvue is pleased to assist retailers with this overlooked market need,” he said.
“Our platform serves as a single efficiency tool for associates, multiple departments, merchants and outside facility vendors, delivering tangible ROI and financial and operational results,” said Robin Walker, Clarvue’s chief operating officer.
“We have a passion for executing projects that make mundane operations and processes more effective and efficient for all types of retailers — health care, discount, specialty, casual/fast dining — whether they operate a handful or thousands of locations,” Walker said. “In our history, we have managed thousands of different projects over tens of thousands of separate locations.”