An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
Insulet Announces FDA 510(k) Clearance of Omnipod® 5 Algorithm Enhancements that Redefine Insulin Delivery and Simplify the Pod Experience
On December 4, Insulet Corporation, announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience.
“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet Executive Vice President and Chief Operating Officer. “These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them. Every improvement we make is designed to strengthen clinical outcomes while making the Pod experience simpler, more personalized, and so seamless it disappears into everyday life.”
More Flexibility with a Lower Target Glucose Setting
The new 100 mg/dL Target Glucose expands Omnipod 5’s customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals. It also directly impacts automated insulin delivery and improves the algorithm’s responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range1 (TBR).
Designed with Patients and HCPs in Mind
In addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased flexibility and greater ease of use, with fewer interruptions to daily life.
“These enhancements to the Omnipod 5 algorithm are a meaningful step forward. As a clinician, it’s exciting to offer patients a system that not only supports strong clinical outcomes but also builds their confidence in managing diabetes daily. More target glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” said Anita Swamy, MD, Pediatric Endocrinologist and Medical Director of the Chicago Children’s Diabetes Center.
The updates to the Omnipod 5 algorithm are anticipated to launch in the United States in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes.
May Health Announces CE Mark for Innovative Treatment for Women with PCOS-related Infertility
On December 16, May Health announced that its novel technology to treat PCOS-related infertility, the Anavi™ System, has received CE Mark certification. The CE Mark, granted under the European Union’s Medical Device Regulation (EU MDR) 2017/745, is a significant regulatory milestone that enables commercialization in the European Union.
PCOS affects approximately 10% to 13% of women worldwide and is the most common endocrine condition impacting reproductive-age women, as well as a leading cause of female infertility. Women with PCOS-related infertility often struggle to become pregnant because they are unable to ovulate consistently or at all. This lack of ovulation in PCOS is linked to dysregulation of androgen production and other hormonal signals within the ovary. First-line pharmacologic therapies are current options to induce ovulation, but they do not work for all patients. For women who do not respond to first-line treatments, care pathways typically progress to more expensive and invasive options such as laparoscopic ovarian surgery or in vitro fertilization (IVF), but many families discontinue fertility treatments rather than proceed with these steps.
May Health introduces a new option: a treatment offered as a one-time, office-based procedure intended to restore natural ovulation in women with PCOS-related infertility who do not respond to, are contraindicated for, or decline first-line medications. Building on the established success of laparoscopic ovarian surgery to restore ovulation,4 this approach translates a laparoscopic procedure into a more accessible, ultrasound-guided in-office option. The Anavi System delivers targeted radiofrequency (RF) energy to ablate a small fraction of ovarian tissue with the aim of re-initiating ovulatory cycles, offering an alternative for women who are not ready, willing, or able to advance to IVF.
“Approximately 80% of women with PCOS have oligo-anovulatory infertility, a condition characterized by lack of ovulation. Moreover, 20–30% of those women do not respond to first-line ovulation induction therapies,” said Saad Amer, lead investigator of the ULTRA EU study, expert in PCOS, endometriosis, and infertility, and professor at the University of Nottingham. “The Anavi System provides a compelling treatment option that restores ovulation in women with PCOS without the use of any hormonal therapy, and as a single, in-office procedure that can be efficiently incorporated into the care pathway for appropriate PCOS women.”
CE Mark certification for the Anavi System was supported by safety and feasibility data from the ULTRA clinical studies conducted in Europe and the United States. Participants were women with PCOS who were anovulatory or oligo-ovulatory and had failed to respond to first-line pharmacologic treatments, or who were contraindicated for or declined such treatment. A preliminary analysis from the ULTRA studies presented at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in 2025 demonstrated:
- In 26 of 32 women evaluable at 12 months, 77% (20/26) reported ovulation, with 13 women experiencing spontaneous ovulation and seven women ovulating after first-line medications were resumed.
- At 12 months, a 46% (12/26) cumulative pregnancy rate was observed, including 10 spontaneous pregnancies (seven with and three without the restart of first-line medication) and two pregnancies with assisted reproductive technology (one intrauterine insemination (IUI), one IVF), resulting in six live births at the time of reporting.
- The most common procedure-related adverse events were reported as mild and included vaginal bleeding, pain, and headache.
The CE Mark permits commercialization of the Anavi System in the European Union, with rollout planned on a country-by-country basis.
In addition, May Health is currently conducting the REBALANCE study in the United States, a pivotal Investigational Device Exemption (IDE) trial designed to support submission to the U.S. Food and Drug Administration (FDA) for marketing authorization.
“The CE Mark represents a significant achievement and an important step toward expanding options for women affected by this challenging condition,” said Colby Holtshouse, President and Chief Executive Officer of May Health. “We are encouraged by these clinical results, which reinforce the potential of this approach to restore ovulation without systemic hormones through a single in-office procedure. We look forward to making the Anavi System available to women across Europe who are struggling with the difficult challenge of PCOS-related infertility.”
About the REBALANCE Study
The REBALANCE Study (NCT06206746) is an ongoing prospective, multicenter, randomized controlled trial evaluating the safety and effectiveness of May Health’s technology for restoring ovulation in eligible women with polycystic ovary syndrome (PCOS)-related infertility. The study is currently recruiting women ages 18–40 who have been diagnosed with PCOS and who have failed, are contraindicated for, or decline first-line ovulation-induction therapies. More than 15 fertility centers across the United States are enrolling participants. Learn more at www.mayhealth.com/rebalance-study.
Zydus and Formycon Enter into an Exclusive Partnership for the Licensing and Supply of Biosimilar to Keytruda® (Pembrolizumab), in U.S. and Canada
On December 9, Zydus Lifesciences Ltd., announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytrud1 (Pembrolizumab) in the U.S. and Canada market.
Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories. The BLA application is expected to be submitted to the USFDA in the near future and is aimed at making immunotherapy affordable and accessible to patients in need.
Commenting on this strategic partnership, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, stated, “We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda® across US and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care.”
Dr. Stefan Glombitza, CEO of Formycon, stated, “FYB206, a biosimilar of Keytruda®, demonstrates Formycon’s advanced expertise in developing biosimilar medicines for highly regulated countries. Partnering with Zydus, an organization recognized for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients. This collaboration strengthens our collective commitment to expanding access to medicines.”
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