Latest news with #JanssenPharmaceuticals
Business Standard
5 days ago
- Business
- Business Standard
Indoco Remedies gains on receiving USFDA nod for Rivaroxaban tablets
Indoco Remedies rose 1.56% to Rs 296.15 after the company announced it had received final approval from the USFDA for its ANDA for Rivaroxaban tablets USP. The approval covers strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Xarelto Tablets, manufactured by Janssen Pharmaceuticals, Inc. The product will be manufactured at Indocos facility in Verna Industrial Area, Goa (L-14, Verna, Goa 403722). Rivaroxaban is an oral anticoagulant used for the treatment and prevention of venous thromboembolism (VTE) a serious condition involving blood clots in the veins, which can lead to complications such as pulmonary embolism. Commenting on the development, Aditi Panandikar, managing director of Indoco Remedies, said, Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US. Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs). The company had reported a consolidated net loss of Rs 40.39 crore in the quarter ended March 2025 as against net profit of Rs 22.70 crore during the previous quarter ended March 2024. Sales declined by 12.57% to Rs 383.89 crore in Q4 FY25 over Q4 FY24.
Business Standard
5 days ago
- Business
- Business Standard
Indoco Remedies receives USFDA approval for Rivaroxaban Tablets
Indoco Remedies announced final approval of the Company's Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg, to market a generic equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen), from USFDA. Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban Tablets USP, will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa 403722 in India. Rivaroxaban is used for the treatment of venous thromboembolism (VTE).
Yahoo
17-04-2025
- Business
- Yahoo
Addex Regains Rights to Phase 2 mGlu2 PAM Asset ADX71149
Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, April 17, 2025 - Addex Therapeutics (SIX/NASDAQ: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, announced today that following the previously announced termination of development of ADX71149 (JNJ-40411813) in epilepsy, its partner Janssen Pharmaceuticals, Inc. (now known as J&J Innovative Medicine) has return all development and commercialization rights to ADX71149 (JNJ-40411813) and the partnership between the two companies has been terminated. 'ADX71149 is a high quality asset which has completed three Phase 2 studies so we are excited to regain control of its development from our partner with its high quality data package and significant material', said Tim Dyer, CEO of Addex. 'We are evaluating a number of high value therapeutic indications for the future development of the program as well as pursuing discussions with a number of potential partners for the program.' About Addex: Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex's partner, Indivior, has selected a GABAB PAM drug candidate for development in substance use disorders. Addex is advancing an independent GABAB PAM program for chronic cough. Addex also holds a 20% equity interest in a private company, Neurosterix LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, mGlu7 NAM for mood disorders and mGlu2 NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol 'ADXN' on each exchange. For more information, visit Contacts: Tim DyerChief Executive OfficerTelephone: +41 22 884 15 55PR@ Mike SinclairPartner, Halsin Partners+44 7968 022075msinclair@ Addex Forward Looking Statements:Addex Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in Addex Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 18, 2024, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking in to access your portfolio
Globe and Mail
11-04-2025
- Health
- Globe and Mail
Ulcerative Colitis Market Set for Robust Growth Across the 7MM from USD 8.4 Billion in 2023
Key Ulcerative Colitis companies in the market include - Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck and Mesoblast, among others. The Ulcerative Colitis treatment paradigm is undergoing a dynamic evolution, marked by increasing therapeutic interventions by companies such as Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck and Mesoblast, among others. DelveInsight's " Ulcerative Colitis Market Insight, Epidemiology And Market Forecast - 2034" report delivers comprehensive insights into the ulcerative colitis market dynamics, epidemiological trends, and treatment landscape across the 7MM which include the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The ulcerative colitis market size in the 7MM was USD 8.4 billion in 2023, with the United States accounting for the largest share at USD 5.9 billion. This market is poised for significant growth during the forecast period (2024-2034), driven by improved drug uptake, increased disease awareness, and a robust pipeline of innovative therapies. Download the Ulcerative Colitis market report to understand which factors are driving the Ulcerative Colitis therapeutic market @ Ulcerative Colitis Market Trends The report also provides a detailed epidemiological analysis and forecasts up to 2034, segmented by Total Diagnosed Prevalent Cases of Ulcerative Colitis, Age-specific Cases of Ulcerative Colitis, Severity-specific Cases of Ulcerative Colitis, and Total Treated Patients of Ulcerative Colitis. According to the latest epidemiological analysis, the total diagnosed prevalent cases of ulcerative colitis in the 7MM comprised approximately 3 Million in 2023, with projections indicating continued growth through 2034. The United States contributed the largest share, with approximately 47% of the diagnosed prevalent population, while Germany and Japan each accounted for roughly 10% of the total 7MM patient pool. When examining disease severity, approximately 521K mild cases and 860K moderate to severe cases were identified across these markets. The ulcerative colitis treatment market currently encompasses multiple therapeutic approaches, including aminosalicylates, corticosteroids, immunomodulators, biologic therapies, S1P modulators, and Janus kinase inhibitors. Anti-TNF alpha agents remain the recommended first-line treatment option for many patients. Among the currently approved therapies, HUMIRA (AbbVie), REMICADE (Janssen Pharmaceuticals), SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), XELJANZ (Pfizer), STELARA (Janssen Pharmaceuticals), CAROGRA (EA Pharma/Kissei Pharma), JYSELECA (Gilead Sciences and Galapagos NV), OMVOH (Eli Lilly), SKYRIZI (AbbVie/Boehringer Ingelheim), RINVOQ (AbbVie), and ZEPOSIA (Bristol-Myers Squibb), among others have established strong market positions. By 2034, ENTYVIO is projected to generate the highest revenue in the United States, followed by HUMIRA (AbbVie). In December 2024, Biocon Biologics and Celltrion received FDA approval for their respective biosimilars to STELARA (Janssen Pharmaceuticals) – YESINTEK (Biocon Biologics) and STEQEYMA (Celltrion) – expanding treatment options for patients with ulcerative colitis. In February 2024, the European Commission granted marketing authorization for VELSIPITY (etrasimod) for patients 16 years and older with moderately to severely active ulcerative colitis following its FDA approval in October 2023. The ulcerative colitis therapeutics market is witnessing significant innovation with several emerging therapies such as, Etrasimod (Arena Pharmaceuticals/Pfizer), ABX464 (Abivax), SHR0302 (Reistone Biopharma), Cobitolimod (InDex Pharmaceuticals), TREMFYA (Janssen Pharmaceuticals), BT-11 (Landos Biopharma/NImmune), PRA023 (Merck), Remestemcel-L (Mesoblast), PF-06651600 (Pfizer) and PF-06700841 (Pfizer) among others. Know which Ulcerative Colitis drug is expected to capture the largest market share in 7MM by 2034. Visit the Ulcerative Colitis Insights Recent developments have further enriched the ulcerative colitis market with several regulatory approvals and clinical advancements. In December 2024, Accropeutics Inc. announced FDA clearance for a Phase II trial of its RIPK2 inhibitor, AC-101, for moderate-to-severe Ulcerative Colitis. Additionally, in November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of TREMFYA (guselkumab). In late 2024, AbbVie's SKYRIZI had rapidly outpaced Eli Lilly's OMVOH in the ulcerative colitis market, securing over double the market share just two months post-launch. In January 2025, the FDA granted investigational new drug (IND) clearance for R-5780 (Rise Therapeutics). This innovative therapy leverages gut-regulated immune pathways to enhance the efficacy of immune checkpoint inhibitors, offering a novel approach to treating cancers that are refractory or unresponsive to these therapies. Looking ahead, the ulcerative colitis market is expected to witness significant transformation with the introduction of novel therapeutic classes, including toll-like receptor 9 activators, miR-124 enhancers, and T-cell therapies. While high therapy costs and complications pose challenges, rising awareness, early screening, and advanced treatment strategies are fueling ulcerative colitis treatment market growth. The ulcerative colitis epidemiology and the market landscape present both opportunities and challenges for stakeholders. As treatment paradigms continue to evolve, focusing on personalized medicine and improved patient outcomes, the ulcerative colitis treatment market is positioned for substantial growth, offering new hope for the millions affected by this chronic inflammatory condition worldwide. Table of Contents 1. Key Insights 2. Report Introduction 3. Ulcerative Colitis Market Overview at a Glance 4. Epidemiology and Market Methodology 5. Ulcerative Colitis Executive Summary 6. Ulcerative Colitis Market Disease Background and Overview 7. Ulcerative Colitis Epidemiology and Patient Population 8. Patient Journey 9. Ulcerative Colitis Marketed Therapies 10. Ulcerative Colitis Emerging Drugs 11. Ulcerative Colitis: The 7MM Analysis 12. Ulcerative Colitis Market Access and Reimbursement 13. Ulcerative Colitis KOL Views 14. Ulcerative Colitis SWOT Analysis 15. Ulcerative Colitis Unmet Needs 16. Appendix 17. DelveInsight Capabilities 18. Disclaimer Related Reports Ulcerative Colitis Pipeline Insight Ulcerative Colitis Pipeline Insight provides comprehensive insights about the Ulcerative Colitis pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Ulcerative Colitis manufacturers, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, and Palatin Technologies, among others. About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
