News Briefs

06/06/2022

Pringles Wavy Chipotle Ranch delivers spicy, cool flavor blend

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pringles wavy chipotle ranch

Pringles is continuing to once again innovate its Wavy chips line with the launch of a brand-new flavor.

Wavy Chipotle Ranch delivers smoky chipotle heat and creamy zesty ranch flavors in a chip that features a thick and wavy texture for an extra bold crunch, the Battle Creek, Mich.-based company said.

“We’re always listening to what our fans crave and pride ourselves on delivering insanely accurate flavor combinations in a single crisp,” said Mauricio Jenkins, U.S. marketing lead at Pringles. “These new crisps boast the perfect balance of spicy and sweet with flavor first and heat second, all while providing Pringles Ranch devotees and snackers alike with a new way to experience this classic bite.”

Consumers can find Pringles Wavy Chipotle Ranch for a limited time at Walgreens stores nationwide.

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06/06/2022

Amgen’s Rituxan biosimilar gets FDA OK for new indication

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Binder with FDA Approved

Amgen has obtained the Food and Drug Administration’s permission for Riabni (rituximab-arrx), a biosimilar to Rituxan, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Riabni already is approved for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (also called Wegener’s granulomatosis) and microscopic polyangiitis.

"The approval of Riabni is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option," said Murdo Gordon, executive vice president of global commercial operations at Amgen. "Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high quality and affordable treatment options that deliver substantial value to our healthcare system."

06/02/2022

Ancient Nutrition unveils Herbal Cider Vinegar supplement

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ancient nutrition herbal cider vinegar

Ancient Nutrition is debuting its new Herbal Cider Vinegar product, which is set to be available in tincture, gummies and capsule formats.

The formula contains the time-honored genius of apple cider vinegar plus a regenerative organic-certified superfood blend of 10 fermented and antioxidant-rich herbs, spices and berries, the Nashville, Tenn.-based company said.

Included in the product’s formulation is organic and uncultured apple cider vinegar that is infused with fermented herbs, spices and berries such as turmeric, goji berry, sumac berry, guava, passionfruit, elderberry fruit, moringa leaf, holy basil leaf, feijoa and key lime.

“Apple cider vinegar has been used for its health-promoting benefits for centuries. Using the power of apple cider vinegar to amplify the benefits of time-honored and revered herbs and spices creates an incredible synergy. Simply put, Herbal Cider Vinegar takes ACV and herbs to the next level!” said co-founder of Ancient Nutrition Dr. Josh Axe. “Fermenting traditional superfoods such as herbs, spices, roots and berries in a raw vinegar culture is an ancient process that is an effective way to capture their beneficial properties. That’s what makes our Herbal Cider Vinegar a one-of-a-kind product that has benefits beyond measure.”

In addition, the Herbal Cider Vinegar product has also been designed to provide users with 3-in-1 benefits that include supporting healthy microbial balance, promoting healthy antioxidant levels, supporting healthy weight management, supporting healthy body composition, promoting cardiovascular health and function, and promoting healthy nutrient metabolism, the company said.

The Herbal Cider Vinegar capsules, tinctures and gummies retail for $24.95 each and will be available for purchase on Ancient Nutrition’s website and Amazon.

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06/02/2022

APhA survey: Majority of pharmacists are prepared to administer COVID-19 shot to kids under 5

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child covid19 vaccine teaser

The majority of responding pharmacists (66%) would be prepared to administer COVID-19 vaccines to children under 5 years old if authorized to do so, according to a recent survey of pharmacists conducted by the American Pharmacists Association.

Nearly half of respondents (44%) said they are currently planning to vaccinate based on community needs and abilities of pharmacy teams following FDA and CDC authorization and guidance. Pharmacists’ level of vaccination engagement for this age group will be an individual practice and practitioner decision. As always, pharmacists stand ready to work with other immunization stakeholders, APhA said.

“The data show that pharmacists are again poised to contribute to our nation’s health efforts and vaccinate all Americans against COVID-19,” said Scott Knoer, APhA executive vice president and CEO. “This has been true since the first COVID-19 vaccines arrived in December 2020, and it continues to be the case today despite the enormous challenges facing pharmacists in every practice venue.”

CDC recently reported that 70% of COVID-19 vaccinations have occurred in pharmacies, including 60% of adolescent vaccinations and 46% of vaccinations in children 5 to 11 years old.

The survey of 612 pharmacists was conducted from Feb. 12, 2022 to March 1, 2022, with respondents from all regions of the country and representing a wide range of practice types, including chain pharmacies, independent pharmacies and supermarket pharmacies. The margin of error in this survey is ±3.9% at the 95% confidence level.

06/02/2022

Galderma releases Epsolay

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galderma eposlay cream teaser

Galderma is introducing Epsolay (benzoyl peroxide) Cream 5%, a topical cream containing benzoyl peroxide 5% for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. 

The company said that the medication is the first and only microencapsulated benzoyl peroxide topical treatment proven to relieve the bumps and blemishes of rosacea and provide rapid, significant and sustained relief.

Over 16 million people in the United States struggle with rosacea, a chronic and recurrent skin condition that can worsen over time. More than 82% of people feel their rosacea is uncontrolled, and less than 50% are satisfied with their current prescription treatments, which can lead to overuse or misuse of these products and can trigger or worsen the condition. Rosacea can be so challenging to manage that 55% of people with the skin condition and a high disease burden reported a willingness to give up one year or more of their life to cure their symptoms, the company said.

"Through our decades-long heritage in dermatology and skin science, Galderma is committed to bringing cutting-edge innovation to patients with rosacea and the healthcare professionals who treat them," said Anthony Pansy, vice president and general manager of the U.S. prescription business at Galderma. "Epsolay Cream represents an important advancement for those who are living with this incredibly challenging skin condition."

A month's supply of Epsolay Cream costs as little as $0 for commercially covered patients with the Galderma CAREConnect savings card at participating pharmacies, according to Galderma.

"Until now, BPO has never been indicated to treat rosacea in part due to its poor tolerability for sensitive skin. Epsolay Cream helps overcome tolerability issues via its patented microencapsulation technology, which controls the gradual release of BPO onto the skin," said Ted Lain, executive director of the Austin Institute for Clinical Research and principal investigator for the Epsolay Cream clinical trials. "Epsolay Cream showed great efficacy and tolerability in the pivotal trials, as evidenced by high patient satisfaction and compliance."

The medication utilizes a proprietary, patented technology licensed from Sol-Gel Technologies to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment.

Sol-Gel Technologies received FDA approval for Epsolay Cream on April 22, 2022 and has granted exclusive rights to Galderma to commercialize the treatment in the United States.

06/02/2022

Biogen, Samsung Bioepis launch Lucentis biosimilar

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Biogen and Samsung Bioepis are launching Byooviz (ranibizumab-nuna), a biosimilar of Genentech’s Lucentis (ranibizumab).

The Food and Drug Administration approved Byooviz, a vascular endothelial growth factor inhibitor, in September 2021 for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. It is the first FDA-approved ophthalmology biosimilar, the companies said.

The list price will be $1,130 per single-use vial to administer 0.5 mg via intravitreal injection, which is 40% lower than the current list price of Lucentis, the company said.

“The launch of Byooviz in the U.S. marks an important moment for patients, healthcare providers, payers and the entire healthcare system,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen. “Patients suffering from retinal vascular disorders now have a more affordable treatment option.”

Healthcare provider engagement, promotional activity and collaborations with professional societies and patient advocacy groups have commenced.

Byooviz will be commercially available on July 1, 2022, through major distributors across the United States.

“Our research with physicians shows cost is cited as a leading barrier to patients initiating treatment, with one-third of patients unable to afford medication,” Henshaw said.“ Byooviz has the potential to expand access to patients suffering from retinal disorders that can result in permanent vision loss while also saving the U.S. healthcare system billions of dollars.”

Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD. Anti-VEGF therapies have become a standard of care treatment for wet AMD, but in real-world settings, costs related with wet AMD treatment often raise challenges in achieving optimal clinical outcomes. The companies said that biosimilars, which are biologics with similar efficacy and safety to reference biologics, can alleviate the financial burden associated with current anti-VEGF therapies.

“The launch of Byooviz, the first ophthalmology biosimilar in the United States, marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.

Byooviz, the first biosimilar launch in the United States under the Biogen and Samsung Bioepis’ partnership, was approved as the first ophthalmology biosimilar in Europe (2021), the United Kingdom (2021) and Canada (2022).

The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, Byooviz and SB15, a biosimilar candidate referencing Eylea (aflibercept).

“The priority of Samsung Bioepis is ensuring patients’ access to the medicines they need, and we will continue to advance our pipeline to bring better access to biologic treatments by leveraging our decade of experience in developing, manufacturing and commercializing these important biologics,” Ko said. 

Samsung Bioepis is responsible for the development, regulatory registration and manufacture of the products while Biogen is responsible for commercialization.