The Food and Drug Administration has given USB its blessing for Fintepla (fenfluramine) oral solution CIV for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.
Fintepla was developed by Zogenix, which was recently acquired by UCB.
The medication already is approved for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
Additionally, the FDA granted Fintepla pediatric exclusivity.
LGS is a severe childhood-onset developmental and epileptic encephalopathy characterized by drug-refractory seizures with high morbidity as well as serious impairment of neurodevelopmental, cognitive and motor functions. It affects an estimated 30,000 to 50,000 patients in the United States.
"The approval of Fintepla for Lennox-Gastaut syndrome highlights our continued commitment to bringing differentiated medicines to patients who may not be well controlled on current therapies, and their caregivers," Mike Davis, head of global epilepsy at UCB said. "We are proud to add Fintepla as a treatment for Dravet syndrome, and now Lennox-Gastaut syndrome, to our portfolio of epilepsy medicines to help reduce the impact and burden of seizures, including severe epilepsy syndromes that have high pediatric morbidity and mortality rates."
Fintepla for LGS is available through a restricted distribution program, called the Fintepla Risk Evaluation and Mitigation Strategy Program.
No Cow, maker of plant-based, low-sugar protein bars and powders, is adding a chocolate-dipped protein bar to its lineup. The Denver-based brand, which launched in 2015, offers gluten-, soy- and dairy-free products that are Non-GMO Project Verified, kosher and vegan.
The new Dipped bars use a proprietary blend of rice and pea protein and feature flavors reminiscent of classic American candies. The six flavors are: chocolate sea salt, chocolate salted caramel, chocolate peanut butter cup, chocolate mint cookie, chocolate sprinkled donut and chocolate coconut almond, the last being the signature flavor of country music star and No Cow brand ambassador Jessie James Decker.
Each bar contains 20 g of plant protein, 3 g to 5 g net carbs and 1 g of sugar.
“Forget about just trying to be the best plant-based option, we truly believe that the new line of Dipped Protein Bars are quite simply the best protein bars on the market, period,” said CEO Eric Haddenhorst. “Early feedback from both consumers and retail partners after a soft launch of two flavors could not have been stronger. Consumers love the taste of these new bars — so many have told us they can’t believe they are plant-based. Of course, they still expect all of the low sugar, high protein, low carb benefits that they’ve come to expect from No Cow.”
The brand’s offerings, which include 19 flavors of protein bars and two flavors of protein powder, are supported by investors that include General Mills’ 301, Valor Equity Partners and Loft Partners.
The single flavor 12-count boxes of the Chocolate Dipped line have a $29.99 SRP.
Dove is rolling out a new line of antiperspirants, dubbed Dove Ultimate Antiperspirant.
The company noted that the line is created with breakthrough water-based technology to help restore underarm skin to its best condition. The formula contains a high concentration of glycerin, which is supposed to soothe dryness and help improve texture, for soft and healthy-looking underarms.
Product highlights also include:
• Water-based technology;
• Glides more easily for a smooth, even feel;
• 6x more humectant moisturizers versus Dove Advanced Care;
• Proven to moisturize skin for longer; and
• 48 hour sweat & odor protection.
Dove Ultimate Antiperspirant is available in six scents: Peony & Rose Water, Cucumber Water & Mint, Coconut & Sandalwood, Jasmine & Vanilla, Orchid & Blackberry and Gardenia & Aloe.
IRI joins Ulta Beauty in multiyear strategic partnership
IRI, a global technology leader in innovative solutions and services for consumer, retail and media companies, and Ulta Beauty are joining forces in a strategic, multiyear partnership aimed at bolstering Ulta Beauty's view of the total beauty market.
"At IRI, we are passionate about understanding and serving the needs of our clients. We couldn't be more excited to support Ulta Beauty in gaining a deeper view of the beauty market and identifying opportunities for innovation and advancement," said Wei Lin Wong, president of global retail and strategy at IRI. "Our personalized solutions will provide Ulta Beauty meaningful data and actionable, real-time insights to elevate their retail strategy."
As part of the partnership, Ulta Beauty will leverage IRI's suite of innovative solutions for e-commerce data, consumer insights and merchandising tools to support its go-to-market strategies.
IRI's solutions identify shoppers' online behavior, provide a 360-degree view of the e-commerce universe and help companies better understand exactly where to invest to drive growth online. Utilizing IRI's consumer and shopper insights solutions allows Ulta Beauty to better understand shopping behaviors, including guests' on-the-go and in-the-moment needs. IRI's innovative platform also enables the retailer to transform its merchandising processes by embedding data into decision-making with easy-to-consume, real-time insights.
"As a data-driven company, we believe in taking a holistic view of retail and consumer channels to unlock meaningful actions," said Jordan Pious, senior director of merchandising strategy and insights at Ulta Beauty. "We're excited to partner with IRI to enhance how we use data and analytics to inform our merchandising strategies and, most importantly, optimize our guests' experiences."
The Food and Drug Administration has approved Keytruda, Merck's anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
"New data from the Keynote-158 trial showed an objective response rate of 46% for certain patients with advanced endometrial carcinoma that is MSI-H or dMMR treated with Keytruda," said David O’Malley, division of gynecologic oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center. "The objective response rate and duration of response observed in this trial solidify the role of Keytruda as a treatment option for these patients."
"This FDA approval is great news for women facing advanced endometrial cancer," said Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories. "We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda, as monotherapy and in combination, with two approved indications in this area. We remain committed to pursuing meaningful advances in gynecologic and breast cancers through our portfolio of medicines."
This is the second indication for Keytruda in endometrial cancer. Keytruda also is indicated in combination with Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Purezero Clean Beauty, an independent hair care brand that offers clean ingredients and salon-quality performance at accessible prices, has a reason to celebrate its recent sustainable practices. The company is the first mass-market hair care brand to secure the Carbonfree Product Certification, a globally recognized carbon-neutral designation from Carbonfund.org Foundation.
Since its creation in 2018, Purezero has prioritized sustainability as a core part of the brand, the company said. Understanding that the use of overseas manufacturing and supply chain operations produces significant carbon emissions, Purezero set out to innovate.
Purezero has hyper-localized its sourcing and production on the Atlantic Coast of Florida to manufacture, warehouse and fulfill products on-site. To earn Carbonfund’s Carbonfree Product certification, Purezero identified viable ways to decrease carbon impact, including a reduction in plastic usage. The partnership with Carbonfund.org allows Purezero to continue those efforts and offset remaining emissions in its footprint.
“The production of personal care and beauty products causes significant carbon emissions, which play a big role in the climate crisis. It’s time to do better by the planet, and we’re leading the way,” said Matt Kuhlman, co-founder, Purezero Clean Beauty. “Consumers have had to choose between professional performance, accessible pricing and clean ingredients — Purezero makes it possible for them to have it all. Now we’ve innovated to democratize clean, sustainable beauty, and this is just the beginning of our hair care revolution.”
“The beauty industry is in desperate need of a sustainable makeover, and working with Purezero on this long-term partnership brings hope for a brighter, more eco-friendly future,” said Eric Carlson, president of Carbonfund.org Foundation. “We’re excited to see a mass hair care brand like Purezero lead the way and set an example for others to follow suit.”
The Carbonfund.org Carbonfree seal will be featured on every Purezero product label in brick-and-mortar retailers nationwide, including Target, Whole Foods Market, Rite Aid, Kroger, Wegmans, Price Chopper, Fred Meyer, King Soopers, Smith’s, Fry’s, Ralphs, QFC, Roundy’s, Dillons, Coburn’s, Market of Choice and more. Also available on Amazon, Purezero was recently inducted into Amazon’s Climate Pledge Friendly Program, which highlights brands that are committed to net-zero carbon across the business.
Purezero noted that it takes its commitment to clean beauty seriously and has banned over 120 harmful, commonly used ingredients from its products, including sulfates, parabens, phosphates, phthalates, dyes and gluten. All products, crafted with a proprietary surfactant product formula, are also PETA-certified cruelty free and vegan. Purezero offers 22 shampoo and conditioner SKUs.