Insulin aspart biosimilar(Sanofi)

Shares in Biocon ticked up about 3% on Tuesday after the FDA greenlit its biosimilar version of Novo Nordisk's rapid-acting human insulin analogue — the first to be deemed interchangeable with NovoLog (insulin aspart).The biosimilar's US approval is years behind other regions; Kirsty (insulin aspart-xjhz) has been available in the EU and Canada since 2022. Biocon gained Kirsty via its $3.3-billion takeout of Viatris in 2022, along with another insulin biosimilar, Semglee (insulin glargine-yfgn), which is interchangeable with Sanofi's Lantus (insulin glargine).While Biocon's product is the first to hold interchangeable status, it's the second insulin aspart biosimilar approved by the US regulator. In February, the FDA cleared Sanofi's Merilog (insulin aspart-szjj).NovoLog was part of the initial batch of 10 drugs subject to pricing negotiations under the US Inflation Reduction Act (IRA). The diabetes treatment reportedly cost the US government $2.6 billion in Part D prescriptions in 2023, but starting in 2026 its list price will be slashed by 76%.

A roundup of the most newsworthy healthcare press releases from PR Newswire, including business strategies shaping the future of healthcare and three major health news trends. NEW YORK, March 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, February 2025. Photos provided by CINDE, Sebela Pharmaceuticals Inc and WeWard. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value "Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care," said Tom Polen, chairman, CEO and president of BD. FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients Self-pay patients with obesity now have additional Zepbound vial options, including 2.5 mg, 5 mg, 7.5 mg and 10 mg doses. In addition to expanding the doses available, Lilly has reduced prices of the 2.5 mg and 5 mg vials to $349 per month and $499 per month, respectively. Costa Rica Continues to Strengthen Its Position as a Leading Hub for Life Sciences Companies Since 2017, Costa Rica's medical device exports have grown at an average annual rate of 18%, surpassing $8 billion in 2024. This rapid expansion has positioned the country as Latin America's second-largest exporter of medical devices and the fifth-largest supplier of these products to the United States. The Cigna Group Launches Actions to Drive Positive Change for Customers and Patients "The health care system in America needs to be better, and we have challenged ourselves to help lead and drive systemic change," said David M. Cordani, chairman and CEO of The Cigna Group. "We do a lot of good for many people, but we need to do better for everyone. We are committed to implementing tangible actions across our company to help drive better health outcomes and health care experiences." Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare, genetic, life-threatening neurodegenerative disease. AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop Novel Tumor-Activated Immunotherapies The collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers. Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B "We are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions," said Bryan Hanson, Solventum CEO. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Chan Zuckerberg Initiative Launches Billion Cells Project with 10x Genomics and Ultima Genomics to Advance AI in Biology "Biology not only needs more data – the field needs more data faster and in interoperable formats to support AI models that address specific problems, and this project represents a unique approach to scaling and standardizing scientific outputs for AI and more," said Jonah Cool, Cell Science Senior Science Program Officer at CZI. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in February, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. American Heart Month: February featured extensive focus on cardiovascular health with diverse awareness initiatives across multiple sectors. Prevention took center stage as Venus Williams invested in the WeWard walking app, Planet Fitness promoted strength training accessibility, and Texas advocates rallied for cardiac emergency response plans in schools during Heart Month. Former Miss Ohio Lindsay Davis joined cardiologists to raise awareness for hypertrophic cardiomyopathy, while NFL Hall of Famer Jerome Bettis partnered with the CDC Foundation's Live to the Beat campaign to address hypertension's impact on Black adults. HIMSS25: The healthcare technology sector generated significant wire activity surrounding the 2025 HIMSS Global Health Conference in Las Vegas (March 3-6). AI innovation dominated announcements, with companies unveiling solutions ranging from Kontaktio's agentic AI for care orchestration to Amtelco's AI-powered virtual agent Ellie. Industry collaboration also emerged as a key theme, with major EHR providers MedAllies, Epic, Netsmart, and eClinicalWorks announcing a joint demo, while Microsoft partnered with Canary Speech to advance digital health transformation. Rare Disease Day: As Rare Disease Day approached on Feb. 28, PR Newswire distributed numerous announcements highlighting advocacy efforts and research breakthroughs. The National Organization for Rare Disorders (NORD) released a critical report on newborn screening programs and later partnered with Paramount Pictures to amplify awareness. The Rare Disease Diversity Coalition prepared to host its 2nd Annual RISE Awards, while NFL legends joined advocates from 49 states for the 14th annual Rare Disease Week on Capitol Hill. Additional mainstream support for the rare disease community came from the New York Stock Exchange with a special pre-market update commemorating Rare Disease Day. Looking ahead: This March, women's health themes will likely dominate coverage surrounding International Women's Day (March 8) and throughout Women's History Month. PR Newswire also anticipates significant activity around National Nutrition Month, with releases spotlighting dietary innovations and wellness campaigns. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. 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