News Briefs

03/24/2022

FDA approves new indication of Merck’s Keytruda

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a close up of a toy

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. 

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03/24/2022

Purezero Clean Beauty earns Carbonfree Product Certification

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Purezero products

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.

03/24/2022

NCPA announces 2022 NICE Awards recipients

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a close up of a wine glass

Six community pharmacies have been named recipients of the 2022 NCPA Innovation Center Excellence Awards, sponsored by RedSail Technologies.

This is the fifth year of the NICE Awards competition, which was created to recognize pharmacies for their efforts to enhance their value, promote their services and better serve their communities.

“For the last five years the NICE Awards have showcased the best in community pharmacy branding and marketing — the innovations and redesigns that make promotions more effective and patients’ experiences more rewarding,” NCPA Innovation Center president Kurt Proctor said. “The aim of the NICE Awards is to spotlight what good pharmacy marketing looks like and what it accomplishes for a pharmacy business. We think it’s nice if others can learn and achieve success as a result of these community pharmacies, and applaud this year’s award recipients for their hard work and creativity.”

“Our goal at RedSail Technologies is to innovate and inspire. The NICE Awards represent independent pharmacies and their drive to grow and succeed by embracing change. We honor that drive here at RedSail, and hope to encourage continued innovation and passion in our customers and the communities they serve,” said Frances Nahas, chief strategy officer at RedSail Technologies.

The 2022 NICE Awards recipients by category are:

  • Best Community Engagement – Phipps Pharmacy in Tennessee

  • Best Exterior Sign – Spruce Mountain Pharmacy in Jay, Maine

  • Best External Modification – Bell Pharmacy in Camden, N.J.

  • Best Internal Modification – Avant Pharmacy and Wellness Center in Charlotte, N.C.

  • Best Delivery Vehicle – Table Rock Pharmacy in Morganton, N.C.

  • Best Marketing/Promotion – Tomahawk Pharmacy in Tomahawk, Wis.

Three independent judges reviewed this year’s submissions and selected the award recipients. Dave Wendland, who has 30 years’ experience with the Hamacher Resource Group, is responsible for strategic partner development and trade relations, and works to strengthen client relationships and enhance product value. Ira Katz, RPh, is owner of Little Five Points Pharmacy in Atlanta. He is known for being a patient advocate with a passion for independent community pharmacy. And Laura Cranston, founder and former CEO of the Pharmacy Quality Alliance, enjoys consulting with organizations innovating around the delivery of clinical services by pharmacists. She is committed to enabling pharmacists to practice at the top of their license and plays a meaningful role in team-based care.

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03/24/2022

Noven receives FDA OK for Xelstrym

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transdermal patch

Noven Pharmaceuticals has obtained the Food and Drug Administration’s clearance for Xelstrym (dextroamphetamine) transdermal system, for the treatment of Attention-Deficit/Hyperactivity Disorder for adults and pediatric patients 6 years and older.

Xelstrym is the first-and-only FDA approved transdermal amphetamine patch, the company said.

“The availability of Xelstrym underscores the need for a non-oral amphetamine treatment for ADHD,” said Greg Mattingly, associate clinical professor of psychiatry at The Washington University School of Medicine in St. Louis, Missouri. “As a once-daily transdermal patch, Xelstrym provides clinicians and their patients, many with varying daily schedules, the ability to share in the decision making process of determining when to apply and subsequently, when to remove the patch to optimize the desired benefit of individualized treatment.”

“FDA’s approval of Xelstrym provides people living with ADHD a new option to manage a medication schedule that fits their individual lifestyle,” Joel Lippman, COO and chief medical officer of Noven, said. “As the first amphetamine transdermal patch available for the treatment of ADHD in adults and pediatrics, this is a significant milestone for Noven and our goal of offering new options for clinicians, caregivers and patients for the treatment of ADHD. This approval enables our team to finalize preparations for commercial launch in the U.S. as early as the second half of this year.”

03/24/2022

Hikma debuts benztropine mesylate in vial format

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Injectables

Hikma is introducing benztropine mesylate injection in a 2mg/2mL dose in a vial format. 

The medication is indicated as an adjunct in the therapy of all forms of Parkinsonism.

Hikma also markets ampoules of this product.

The company shared that this launch broadens the choice of medicines available to hospitals.

Benztropine mesylate injection had a market value of approximately $5 million in the 12 months ending December 2021, according to IQVIA.

03/24/2022

Novartis gains FDA nod for Pluvicto

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Stamp saying approved

The Food and Drug Administration has given Novartis the green light for Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

The therapy is for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer that has spread to other parts of the body (metastatic). These patients have already been treated with other anti-cancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).

"The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options," Oliver Sartor, medical director at Tulane Cancer Center, said. "Pluvicto is a step forward in the evolution of precision medicine for prostate cancer."

Pluvicto is the first targeted FDA-approved radioligand therapy for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle), and is expected to be available to physicians and patients within weeks.

The FDA also has approved Locametz (kit for the preparation of gallium Ga 68 gozetotide injection). After radiolabeling, this imaging agent may be used to identify PSMA-positive lesions in adult patients with mCRPC through a positron emission tomography scan. Gallium-68 labeled Locametz can identify tumor lesions expressing the PSMA biomarker and locate where in the body tumors may have spread (e.g., in soft tissue, lymph nodes, or bone), identifying patients eligible for targeted treatment with Pluvicto. PSMA is highly expressed in more than 80% of patients with prostate cancer, making it an important phenotypic biomarker for assessing the progression of metastatic prostate cancer. Locametz is expected to be available to physicians and patients within weeks.

"With our unique strategy to tackle cancer by leveraging four therapeutic platforms, I am thrilled that with Pluvicto, we are bringing the targeted RLT platform to bear for treating eligible patients with mCRPC," Susanne Schaffert, president of Novartis Oncology, said. "Today's approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients."

"Prostate cancer is the second-leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients," Jamie Bearse, CEO and president at ZERO – The End of Prostate Cancer, said. "The approval of Pluvicto offers new hope to the mCRPC community."