Eli Lilly has obtained the Food and Drug Administration’s blessing for Mounjaro (tirzepatide) injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise.
Glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide are hormones involved in blood sugar control. Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which lead to improved blood sugar control, the company said.
"Given the challenges many patients experience in achieving their target blood sugar goals, today's approval of Mounjaro is an important advance in the treatment of Type 2 diabetes," said Patrick Archdeacon, associate director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research.
"Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with Type 2 diabetes who could be treated in clinical practice," said Juan Pablo Frías, medical director of the National Research Institute and Investigator in the SURPASS program. "The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials."
"Lilly has a nearly 100-year heritage of advancing care for people living with diabetes — never settling for current outcomes. We're not satisfied knowing that half of the more than 30 million Americans living with Type 2 diabetes are not reaching their target blood glucose levels," said Mike Mason, president of Lilly Diabetes. "We are thrilled to introduce Mounjaro, which represents the first new class of Type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community."
Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals. It is expected to be available in the United States in the coming weeks.
It will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg) and will come in Lilly's well-established auto-injector pen, with a pre-attached, hidden needle that patients do not need to handle or see, the company said.
MegaFood intros Extra Strength Sleep Melatonin Gummies
MegaFood wants to aid consumers who are having difficulty getting a good night’s sleep.
The latest launch from the Manchester, N.H.-based company is the Extra Strength Sleep Melatonin Gummies.
Featuring 10 g of melatonin per serving in an orange blossom flavor, the gummies are formulated to help consumers fall asleep quickly, the brand said.
Made with chamomile and lemon balm, the product is Non-GMO Project Verified, Certified Glyphosate Residue Free and does not contain high fructose corn syrup or gelatin.
“Sleep plays a critical role in our overall health and wellness, and getting enough sleep at night should never feel unattainable,” said Erin Stokes, a naturopathic doctor and medical director at MegaFood. “Our new Extra Strength Sleep Gummies are intended for occasional use to help you fall asleep faster and support a healthy sleep cycle.”
Sandoz is launching generic pirfenidone, the first generic of Genentech’s Esbriet.
The oral medicine, which is used to treat patients with idiopathic pulmonary fibrosis, is immediately available to patients via specialty pharmacies, with a $0 co-pay program for eligible patients, the company said.
Idiopathic pulmonary fibrosis, or IPF, is a progressive rare disease with no cure that causes irreversible lung scarring and makes it difficult to breathe. It primarily affects adults over the age of 50 years old, and is more common in men. Approximately 140,000 Americans live with IPF. In addition to medicines that can slow the progression of scar tissue formation, it is recommended that patients stay active, eat well and use oxygen therapy as prescribed.
“Sandoz is putting patients first by expanding access to generic pirfenidone for those living with this rare disease, who will benefit from a more affordable, yet equally effective treatment,” said Keren Haruvi, president of Sandoz. “We developed this medicine in-house and continue to build our expertise and infrastructure to support our long-term commitment to grow our respiratory portfolio.”
Upsher-Smith is making changes to its executive leadership.
Taku Nakaoka has been appointed chairman and CEO of Upsher-Smith, effective May 13. Additionally, Rich Fisher, senior vice president of corporate strategy, has been named president and chief operating officer. He is responsible for the day-to-day leadership of Upsher-Smith.
Nakaoka succeeds Rusty Field, who previously served as president and CEO and recently departed the company to pursue another opportunity.
As chairman and CEO, Nakaoka is responsible for the strategic direction, operating performance and growth of Upsher-Smith. Nakaoka also serves as corporate officer and group chief officer of corporate strategy of Sawai Group Holdings, Upsher-Smith’s parent company, and corporate officer and general manager of corporate strategy at Sawai. Prior to Sawai, he had several executive-level positions at Sumitomo.
“I am honored to assume this role as chairman and CEO, and look forward to working alongside the executive team to drive the strategic direction of the company, expand global partnerships and enhance programs critical to future growth,” Nakaoka said. “Rusty’s strong and determined leadership over the past eight years was integral to building a strong foundation for Upsher-Smith, and Rich Fisher’s previous role as senior vice president of corporate strategy makes him well-positioned to successfully lead the company as president and COO.”
Everyware, a leading contactless payments and customer engagement solutions company, is rolling out Pay By Text, a functionality which allows customers to use their cell phone number to make a payment.
Through its collaboration with Visa, Everyware is leveraging Token ID, which empowers banks, merchants, regional payments schemes, clearing houses and other payments stakeholders like Everyware to build, manage and control their own tokenization capabilities.
Through Token ID, Everyware will act as a token requestor, requesting network tokens on behalf of their clients and enabling their customers to pay with just a cell phone number across merchants and payment processors, wherever Visa is accepted.
Visa’s transformative tokenization technology, in conjunction with Everyware’s solution, allows customers to simply respond ‘yes’ by text message to quickly and safely authorize a payment. Everyware will provide this payment method, enabled by Token ID, to payment processors, gateways and software companies so their customers will be able to have a better checkout experience and will see increased authorization success rates across all card types.
“Network tokenization has taken a giant step forward in security and value for card-not-present transactions," said Larry Talley, founder & CEO of Everyware. “Through the power of the Network Token, Everyware can provide a frictionless payment experience."
The pandemic propelled contactless payments into modern day, and Everyware is now able to provide merchants with more convenient payment options without jeopardizing security. In fact, network tokenization minimizes the impact of security breaches and helps online merchants improve their data security by eliminating the actual storage of credit card numbers in any internal systems, the company said. Experts predict that retailers will lose about $130 billion between 2018 and 2023 to fraud. Network tokenization ensures that card details are protected throughout the entire transaction lifecycle.
NowRx, Hyundai Motor Group partner on last mile medication delivery
NowRx, a tech-powered pharmacy that provides same-day prescription delivery and telehealth services, and Hyundai Motor Group, a global scale mobility provider including Hyundai Motor and Kia, are set to kick off a pilot project to explore the use of new solutions in the delivery of prescription medications.
The parties plan to launch the project later this year, serving two micro-fulfillment centers in the Los Angeles area. The pilot includes aspects of automated dispatch, fleet management and other last mile optimization technologies, with the extended scope to test autonomous vehicle technologies in the future.
Supported by the Innovation division of the Group, NowRx plans to combine its proprietary pharmacy management system QuickFill capabilities and the Group’s smart mobility solutions. The synergies are expected to provide a seamless healthcare experience to end consumers.
“Autonomous vehicles are part of our long-term strategic vision for NowRx to further reduce delivery costs at scale,” said Cary Breese, CEO and co-founder of NowRx. “We can’t imagine a better company to work with than the Group, which has demonstrated substantial leadership in the autonomous vehicle, and other robotics and automation areas.”
“The Group expects this collaboration with NowRx to help expand our mobility business model beyond the anticipated industry,” said Minsung Kim, vice president of Hyundai Motor Group and head of the Open Innovation Strategy Team. “We believe a new opportunity with the technologically innovative e-pharmacy NowRx, that uniquely integrates pharmacy management and delivery service, supports our movement toward smart mobility solutions provider.”