Latest news with #Victoza®
Business Upturn
02-06-2025
- Business
- Business Upturn
Biocon receives CDSCO approval for its Liraglutide drug in India
Biocon Limited, a global biopharmaceutical company, has announced that it has received regulatory approval in India for its Liraglutide drug substance. Its wholly owned subsidiary, Biocon Pharma Limited, has also secured approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge) from the Central Drugs Standard Control Organisation (CDSCO). The product is a generic version of Victoza®, used as an adjunct to diet and exercise to improve glycemic control in adults, adolescents, and children aged 10 years and older with Type 2 Diabetes Mellitus that is not adequately managed. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, commented, 'The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon's mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India'' This approval was granted under the CDSCO's recently introduced 101 route. This regulatory pathway allows for the recognition of approvals issued by referenced and established foreign regulatory agencies, thereby facilitating faster access to critical medicines in India. Glucagon-like peptide-1 (GLP-1) therapies, including Liraglutide, are being recognized as a growing segment in diabetes management. Biocon has stated its intent to expand its portfolio in this category as part of its future business strategy. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Associated Press
02-04-2025
- Business
- Associated Press
Lexaria's Human GLP-1 Study #5 Begins Dosing
Head-to-head human study comparing traditional injected liraglutide to first-ever oral DehydraTECH-liraglutide Study will investigate Pharmacokinetics and Safety KELOWNA, BC / ACCESS Newswire / April 2, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, is pleased to announce that dosing has begun as scheduled in its human study GLP-1-H25-5 (the 'Study') that is comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide. On November 20, 2024, Lexaria reported on an earlier 12-week study in rodents which showed that with unlimited food available, oral DehydraTECH-liraglutide demonstrated a 5.88% weight reduction and an 11.54% blood sugar reduction as compared to baseline. The current Study is designed to test pharmacokinetics ('PK') (absorption into bloodstream) and adverse events in humans. Lexaria has previously shown in other GLP-1 PK studies in humans, that certain oral DehydraTECH formulations demonstrated superior bloodstream delivery, as well as reduced adverse events as compared to the oral semaglutide and injectable tirzepatide products on the market today. Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk. Despite the launch of a genericized version of liraglutide by Teva Pharmaceutical Industries, Ltd. in June of 2024, Novo Nordisk generated US$1.0 billion in Saxenda® revenue, as well as an additional US$0.8 billion in Victoza® revenue during 2024. Results of the Study will be released once available. About Lexaria Bioscience Corp. & DehydraTECH DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide. For more information, please visit CAUTION REGARDING FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as 'anticipate,' 'if,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'could,' 'should,' 'will,' and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Phone: 250-765-6424, ext 202
