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Associated Press
14-03-2025
- Health
- Associated Press
Weekly Roundup: 15 Health Press Releases You Need to See
A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including business acquisition news from Sun Pharma and Labcorp as well as new research from the National Sleep Foundation. NEW YORK, March 14, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. 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. Sun Pharma to Acquire Checkpoint Therapeutics 'We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option,' said James Oliviero, President and Chief Executive Officer of Checkpoint. Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. Findings revealed 78% of Americans aren't aware of all the treatment options available for sleep apnea and only 1 in 4 Americans can identify the health consequences of untreated sleep apnea. The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. This year's recipients include 442 hospitals from 40 states and represent the top 10% of hospitals in the nation for patient safety. Patient safety is a vital component of achieving the best possible health outcomes, ensuring that serious injuries and complications are minimized for patients during hospital stays. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases. Make-A-Wish Receives $250,000 Grant from U.S. Bank Foundation to Help Support Life-Changing Wishes Nationwide 'Together with the U.S. Bank Foundation, we look forward to granting wishes that can replace fear with hope and transform the lives of wish kids and their families,' said Leslie Motter, president and CEO of Make-A-Wish America. While the new year traditionally inspires health-oriented resolutions, current economic pressures are adding a layer of complexity. Rising food prices further complicate efforts to prioritize nutrient-dense options in grocery carts, creating a substantial barrier for many. Clayman Thyroid Center Launches Inaugural Hashimoto's Disease Awareness Day on March 12 Hashimoto's Disease Awareness Day, to be observed annually on the second Wednesday in March, is designed to bring much-needed attention to Hashimoto's thyroiditis, an autoimmune condition that affects millions yet remains misunderstood, underdiagnosed, and often dismissed. The American Diabetes Association Announces the 2025 National Scientific and Health Care Achievement Award Winners 'The diligent work of these passionate professionals is moving us closer to a world free of diabetes. Their contributions to research, prevention, and treatment are creating lasting change and improving the lives of people affected by diabetes,' said Charles 'Chuck' Henderson, the ADA's chief executive officer. 'With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families,' said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. The conference featured 600+ educational sessions, 950+ exhibitors, numerous networking opportunities and a highly attended hosted buyer program that facilitated crucial conversations about the future of healthcare technology and delivery models. Data Shows Quality of Life Improves for Spouses of Hip and Knee Replacement Patients When spouses were surveyed about their own quality of life compared to before their spouse's surgery, 70% said their quality of life was slightly or significantly better, 28% noted no change and 2% reported a slightly worse quality of life. Sesame Place Philadelphia Is First Theme Park in North America to Launch Hidden Disabilities Sunflower Program Part of a global initiative designed to support people with non-visible disabilities and conditions, the program consists of a wearable Sunflower-branded tool that discreetly signals to Sesame Place Ambassadors that a guest may need extra help, understanding, or time due to a disability or condition that may not be immediately apparent. Count Me In Launches New Patient-Partnered Research Project for Translocation Renal Cell Carcinoma tRCC is a unique type of kidney cancer caused by specific genetic changes called translocations, where parts of chromosomes swap places or rearrange. Due to its rarity, research on tRCC has historically been limited, leaving patients and families with few therapeutic options and many unanswered questions. For more news like this, check out all of the latest health-related releases from PR Newswire. 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. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected].
Yahoo
09-03-2025
- Health
- Yahoo
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).[2] "We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers," said Hetal Patel, Vice President of Medical Affairs at Celltrion USA. "The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product." The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks. From Week 12, patients who received OMLYCLO were continued on OMLYCLO, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to OMLYCLO or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods.[1] An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.[3] "The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S." About OMLYCLO® (omalizumab-igec) OMLYCLO® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR® (omalizumab). OMLYCLO 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe is approved as interchangeable with reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.[1],[2] OMLYCLO was also approved by the European Commission (EC) in May 2024. INDICATION OMLYCLO® (omalizumab-igec) injection, is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment Limitations of Use: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis. Contraindications: Severe hypersensitivity reaction to OMLYCLO or any ingredient of OMLYCLO. Anaphylaxis. Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities. Patients should be monitored for an appropriate period post-administration, informed of symptoms, and instructed to seek immediate medical care if they occur. Malignancy. Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown. Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Corticosteroid Reduction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP. Eosinophilic Conditions. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. Fever, Arthralgia, and Rash. Stop OMLYCLO if a patient develops this constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy. Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy. Laboratory Tests. Omalizumab increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation to reassess dosing regimen, as they may not reflect steady-state free IgE. Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens. Most Common Adverse Reactions Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. CRSwNP: In ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness. IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia. CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough. For more information, see Full Prescribing Information. About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks OMLYCLO® is a registered trademark of CELLTRION, is a registered trademark of Novartis AG. References [1] Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at: [Last accessed March 2025] [2] OMLYCLO U.S. prescribing information (2025) [3] U.S. Food and Drug Administration (FDA). Available at: [Last accessed March 2025] US-OML-25-00001 For further information please contact: Andria Arenaaarena@ 516-578-0057 View original content to download multimedia: SOURCE Celltrion
