Shilpa Medicare Secures SEC-CDSCO Nod for Nor-Ursodeoxycholic Acid Tablets, Eyes Market Launch for NASH
NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition.
Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled, 'A phase - III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study', to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC.
The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include:
Liver Fibrosis Reversal: 83.3% of participants showed fibrosis reversal, with stabilization in the rest.
ALT Normalization: Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks.
These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction.
Commenting on the development, Mr. Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited, said, 'We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally.'
Founded in 1987, Shilpa Medicare offers APIs, Formulations, and Biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
21 hours ago
- Yahoo
RingConn Gen 2 Now Available on Walmart.com, Bringing Advanced Sleep Apnea Monitoring to More Consumers
LOS ANGELES, July 23, 2025 /PRNewswire/ -- RingConn, a leading smart ring innovator, has officially launched its flagship Gen 2 Smart Ring and accessories on marking a significant milestone in its U.S. retail expansion. This partnership with Walmart, the nation's largest retailer, enhances RingConn's mission to make advanced health technology more accessible to everyday consumers. As one of the fastest-growing categories in consumer technology, smart wearable devices have become a key area of investment for Walmart, supporting improvements in employee safety, warehouse efficiency, and customer service. In response to the rising demand for personalized, preventive health tools, Walmart has steadily expanded its health-focused wearable offerings this year, adding new-generation devices and advanced sleep tracking wearables. The arrival of RingConn marks a significant step in Walmart's ongoing product diversification strategy—moving beyond traditional wrist-worn formats to offer customers a more compact, discreet, and medically insightful solution. Leveraging its leading technology and innovative design, RingConn has quickly established itself as a benchmark brand in the smart ring segment. Unique features such as advanced sleep tracking, an integrated AI health partner, and ultra-lightweight craftsmanship have earned it recognition from over 200,000 users worldwide. The United States—one of the most mature health tech markets, where consumers value data privacy and proactive health management—has long been a core focus for RingConn. The brand has seen rapid growth in the U.S., becoming a trusted name in smart rings. With its launch on RingConn will leverage Walmart's scale to reach a broad, diverse consumer base and accelerate its North American expansion. The RingConn Gen 2 Smart Ring, now available at was launched in late 2024 and broke a Kickstarter category record with $4.4 million in crowdfunding. It's the world's first smart ring to offer sleep apnea monitoring. Besides, Gen 2 holds several technical distinctions: Lightest available model at 2-3 grams, and thinnest profile in its category at 2mm Extended battery life of 10-12 days Cross-platform compatibility (Android/iOS) with no subscription fees Advanced menstrual cycle monitoring feature To ensure optimal customer experience, Walmart consumers can first order a sizing kit to determine their perfect fit before purchasing the smart ring. This partnership with Walmart marks an important step in RingConn's mission to make smart, approachable health technology available to consumers. About RingConn Established in 2021, RingConn is a leading personal health technology company dedicated to creating innovative products and services that transform the experience of maintaining personal wellness. Guided by the principle of "Hardware + Software + Services," RingConn aims to provide unique products and services for people's health. View original content to download multimedia: SOURCE RingConn LLC
Yahoo
a day ago
- Yahoo
Blood Pressure Cuffs Market worth $1.3 billion in 2032 with 9.0% CAGR
DELRAY BEACH, Fla., July 23, 2025 /PRNewswire/ -- The global Blood Pressure Cuffs Market, valued at US$0.6 billion in 2024 stood at US$0.7 billion in 2025 and is projected to advance at a resilient CAGR of 9.0% from 2025 to 2032, culminating in a forecasted valuation of US$1.3 billion by the end of the period. The increasing global burden of chronic non-communicable diseases, including hypertension, obesity, and cardiovascular disorders, primarily drives the expansion of the blood pressure monitoring market. These conditions significantly increase blood pressure levels, necessitating consistent monitoring and management. Moreover, heightened public and clinical awareness of hypertension and its associated complications has led to greater demand for effective diagnostic and monitoring solutions. Concurrently, market growth is further supported by continuous technological advancements and product innovation by key industry players. These developments include introducing non-invasive, automated, and wearable blood pressure monitoring devices to improve accuracy, usability, and patient compliance. Download PDF Brochure: Browse in-depth TOC on "Blood Pressure Cuffs Market" 376 - Tables 50 - Figures 309 - Pages By type, the blood pressure cuffs market is divided into automated and manual segments. Appropriately validated automated blood pressure measuring devices (BPMDs) are considered the preferred standard for clinical diagnosis and management of hypertension. The growth of the automated segment is primarily fueled by the increasing incidence of cardiovascular diseases and the widespread adoption of advanced technologies that offer greater accuracy, ease of use, and efficiency in blood pressure monitoring. By end users, the blood pressure cuffs market is segmented into hospitals, home care settings, ambulatory care centers, urgent care centers, primary centers, and other end users. As of 2024, the hospitals segment accounted for the largest market share. The large share of the segment can be attributed to the higher purchasing power of hospitals. Hospitals are equipped with advanced monitoring technologies and follow standardized clinical procedures, which ensure reliable blood pressure readings. The growing prevalence of cardiovascular diseases and the increasing number of hospital admissions, especially among the elderly population, further drive demand for high-quality blood pressure cuffs in these settings. By geography, the blood pressure cuffs market is segmented into five regional segments: North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is expected to grow at the highest CAGR of 10.8% during the forecast period. This rapid expansion is driven by several key factors, including emerging economies such as China, India, and Japan, which are experiencing a surge in healthcare demand. The rising incidence of chronic illnesses, particularly hypertension, and cardiovascular diseases, combined with a growing awareness of early diagnosis and disease prevention, is fueling market growth in the region. Request Sample Pages : The prominent players in the blood pressure cuffs market include OMRON Corporation, Inc. (Japan), Baxter International, Inc. (US), Koninklijke Philips N.V. (Netherlands), GE HealthCare Technologies, Inc. (US), and McKesson Corporation. (US), B Braun Melsungen AG (Germany), Halma plc (Uk), OSI Systems, Inc. (US), American Diagnostic Corporation (US), Medline Industries, LP. (US), Microlife Corporation (Switzerland), BIOS Medical (UK), ACCOSON (UK), CellBios (India), and Midmark Corporation (US), among others. BAXTER INTERNATIONAL INC. (US): Baxter International Inc., through its subsidiaries, provides a broad range of essential healthcare products, including diagnostic & patient monitoring technologies and respiratory care devices. These products are used in diverse healthcare environments such as hospitals, nursing homes, rehabilitation centers, ambulatory surgical centers, physicians' offices, and home care settings under medical supervision. The company operates globally through four main segments: Medical Products and Therapies, Healthcare Systems and Technologies, Pharmaceuticals, and Kidney Care. The Healthcare Systems and Technologies segment—connected care solutions, collaboration platforms, monitoring systems, and diagnostic tools such as blood pressure cuffs—is a key component of Baxter's overall strategy. OMRON CORPORATION (JAPAN) OMRON Corporation is a global leader known for offering a diverse portfolio of products across multiple industries. The company operates through four primary business segments: Industrial Automation, Healthcare Business, Social Systems, Solutions and Service Business, and Device & Module Solutions Business. OMRON Healthcare Co., Ltd., a subsidiary of Omron Corporation, specializes in medical devices and health management solutions. This division is recognized as a market leader in cardiovascular care, respiratory health, pain management, remote patient monitoring, and home healthcare equipment—particularly blood pressure monitors. MCKESSON CORPORATION (US) McKesson Corporation and its subsidiaries are a prominent provider of diverse healthcare services dedicated to improving patient health outcomes worldwide. The company operates through four main business segments: US Pharmaceutical, Prescription Technology Solutions (RxTS), Medical-Surgical Solutions, and International. The Medical-Surgical Solutions segment plays a key role in delivering a wide range of medical-surgical products—including blood pressure cuffs—as well as logistics, distribution, and support services to various healthcare providers such as physician offices, surgical centers, nursing homes, hospital labs, and home health care agencies. McKesson collaborates with manufacturers and channel partners to effectively serve these markets, focusing on key sectors such as primary care, extended care, government, and other healthcare markets. For more information, Inquire Now! Related Reports: Pulse Oximeter Market Patient Monitoring Devices Market Home Healthcare Market Respiratory Care Devices Market Pressure Monitoring Market Get access to the latest updates on Blood Pressure Cuffs Companies and Blood Pressure Cuffs Market Size About MarketsandMarkets™: MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. To find out more, visit or follow us on Twitter , LinkedIn and Facebook . Contact:Mr. Rohan SalgarkarMarketsandMarkets™ INC. 1615 South Congress 103, Delray Beach, FL 33445USA: +1-888-600-6441Email: sales@ Our Website: Logo: View original content: SOURCE MarketsandMarkets Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
a day ago
- Yahoo
Trailhead Biosystems® Expands Human Cell-Based Product Line with iPSC-Derived A9 Dopaminergic Neurons
BEACHWOOD, Ohio, July 23, 2025 /PRNewswire/ -- Trailhead Biosystems, Inc. ( a biotechnology company pioneering the creation of induced pluripotent stem cell (iPSC)-derived human cells at scale for drug discovery and cell therapy, introduces TrailBio® A9 Dopaminergic Neurons, a powerful new tool available off-the-shelf for studying Parkinson's disease and other neurodegenerative conditions. A9 dopaminergic neurons play a critical role in movement regulation and are disproportionately affected in Parkinson's disease. Historically, researchers have lacked access to viable human models, relying instead on animal studies with limited relevance. With TrailBio® A9 Dopaminergic Neurons, scientists now have a human-specific platform to investigate disease mechanisms, develop therapies and accelerate drug discovery. "TrailBio® A9 Dopaminergic Neurons open new possibilities for Parkinson's research," said Dr. Jan Jensen, Chief Scientific Officer, Chief Technology Officer and founder of Trailhead Biosystems. "These cells enable researchers to study the vulnerabilities of A9 neurons, helping drive progress toward more effective treatments." "For decades, the lack of human A9 neurons has limited our ability to truly understand Parkinson's disease," added Dr. Nooshin Amini, Scientific Director at Trailhead Biosystems. "Now, with TrailBio® A9 Dopaminergic Neurons, researchers can directly study the exact cells that are most affected, offering hope for groundbreaking insights and future therapies." About Trailhead Biosystems Trailhead Biosystems, Inc. is pioneering an informatics-based approach in regenerative medicine and drug discovery. Founded in 2015 as a spinout from the Cleveland Clinic and Case Western Reserve University, Trailhead emerged from the research of CSO/CTO and founder Dr. Jan Jensen. Trailhead creates optimized human cells at scale with its proprietary High-Dimensional Design-of-Experiments (HD-DoE®) platform, integrating advanced mathematical modeling with high-throughput robotic manufacturing. This innovative system allows Trailhead to develop specialized, high-quality iPSC-derived human cells for drug discovery and cell-based therapies. TrailBio® A9 Dopaminergic Neurons represent one of many specialized human cell types emerging from this platform, with additional cell models expected in the near future. Learn more about Trailhead Biosystems, TrailBio® A9 Dopaminergic Neurons and HD-DoE® at For more information, please contact: Tim Mauk, Corporate CommunicationsTrailhead BiosystemsEmail: info@ View original content to download multimedia: SOURCE Trailhead Biosystems Inc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
