Latest news with #USFDA
Business Standard
a day ago
- Business
- Business Standard
Alembic Pharma receives USFDA final approval for Bosutinib tablets
Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets. Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have shown resistance or intolerance to prior therapy. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, marketed by PF Prism C.V. (Pfizer). According to IQVIA, Bosutinib Tablets have an estimated market size of $ 291 million for the twelve months ending March 2025. Alembic has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter rose 0.97% to Rs 1,015.30 on the BSE.
Business Upturn
a day ago
- Business
- Business Upturn
Alembic Pharmaceuticals shares in focus after USFDA nod for cancer drug Bosutinib
By Aditya Bhagchandani Published on May 30, 2025, 12:04 IST Shares of Alembic Pharmaceuticals may be in focus after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic Bosutinib Tablets in 100 mg and 500 mg strengths. Bosutinib is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. According to IQVIA data, the estimated market size for Bosutinib Tablets in the US stood at USD 291 million for the twelve months ending March 2025. Alembic stated that the approved product is therapeutically equivalent to Bosulif Tablets, originally marketed by PF Prism C.V. With this latest nod, Alembic has received a cumulative total of 223 ANDA approvals from the USFDA, comprising 200 final approvals and 23 tentative approvals. This development reinforces Alembic's commitment to expanding its oncology portfolio in the US generics market. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Standard
3 days ago
- Health
- Business Standard
Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment
Zydus Lifesciences announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track Designation to Usnoflast (ZYIL1), a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Drugs granted this designation are eligible for benefits such as accelerated approval, priority review, and more frequent interactions with the USFDA during the drug development process. The company stated that people living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to the formation of neurofilaments, which first accumulate in the cerebrospinal fluid (CSF) of ALS patients and then slowly enter the bloodstream. Due to rapid neurodegeneration, steady loss of the ability to move, speak, eat, and eventually breathe, paralysis and death are common outcomes in ALS patients. ALS affects approximately 32,000 people in the U.S., with an average of 5,000 new patients diagnosed every year, according to statistics from the Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS. Usnoflast, a novel chemical entity (NCE), had earlier received Orphan Drug Designation (ODD) from the USFDA, which offers development incentives including tax credits for clinical testing, waiver of certain FDA fees, and a potential seven-year marketing exclusivity upon USFDA approval. Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor studied in preclinical models of neuroinflammation, Parkinsons disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS). Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial in 24 ALS patients across seven sites in India and recently received USFDA approval to initiate a Phase 2(b) randomized, double-blind, placebo-controlled trial in ALS patients. Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, This Fast Track Designation in addition to the previous Orphan Drug Designation granted by the USFDA, underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter. The counter shed 0.30% to Rs 915.22 on the BSE.
Business Upturn
4 days ago
- Health
- Business Upturn
Zydus receives USFDA Fast Track Designation for Usnoflast in the treatment of ALS
By Aman Shukla Published on May 28, 2025, 11:14 IST Zydus, a discovery-driven global pharmaceutical company, has announced that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation to its investigational drug, Usnoflast, for the treatment of amyotrophic lateral sclerosis (ALS). This designation is intended to expedite the development and review of drugs that address serious conditions and fill an unmet medical need. It allows for more frequent communication with the FDA and makes the drug eligible for accelerated approval and priority review, provided certain criteria are met. ALS is a progressive neurodegenerative disease that primarily affects motor neurons. Patients with ALS typically experience muscle weakness, loss of motor control, difficulty speaking and swallowing, and ultimately respiratory failure. The average life expectancy following diagnosis ranges from two to five years. Neuroinflammation and axonal degeneration are key features of the disease, contributing to the buildup of neurofilaments in cerebrospinal fluid and, eventually, in the bloodstream. This process is linked to the rapid progression and severe impact of ALS on physical function and quality of life. Usnoflast, also known as ZYIL1, is an oral small molecule that targets the NLRP3 inflammasome pathway, which is believed to play a role in neuroinflammatory diseases. The drug has shown promise in pre-clinical studies involving models of neuroinflammation, Parkinson's disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). In India, Zydus completed a Phase 2(a) randomized, double-blind, placebo-controlled trial of Usnoflast in 24 ALS patients across seven clinical trial sites. The study is registered under the Identifier NCT05981040. Building on this research, Zydus has received USFDA approval to begin a Phase 2(b) clinical trial in the United States. This upcoming study will also be randomized, double-blind, and placebo-controlled, further evaluating the potential of Usnoflast as a treatment option for ALS. ALS affects an estimated 32,000 individuals in the U.S., with approximately 5,000 new cases diagnosed each year. In Europe, more than 30,000 people are believed to be living with the condition, and in India, the number is estimated to be around 75,000. 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
Yahoo
4 days ago
- Business
- Yahoo
Shilpa Medicare Ltd (BOM:530549) Q4 2025 Earnings Call Highlights: Revenue Growth and Strategic ...
Release Date: May 26, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Shilpa Medicare Ltd (BOM:530549) reported a 15% year-on-year growth in total revenue for the quarter, reaching INR 338 crore. The company's gross margin improved by 200 basis points to 69% compared to the same quarter last year. The formulation business saw a significant 38% year-on-year growth, driven by limited competition in the European market for certain products. The biologics division is expected to double its sales in the current financial year due to additional indications approval. Shilpa Medicare Ltd (BOM:530549) successfully completed USFDA inspections for its API business units, receiving EIR with VI status for one unit. The company's licensing revenue decreased from INR 34 crore in Q4 FY24 to INR 24 crore in Q4 FY25, indicating variability in this income stream. There is a delay in the start of phase 3 clinical trials for a key biologic product, potentially impacting timelines. The US FDA import alert on the formulation manufacturing facility remains unresolved, affecting potential margin improvements. The API business has experienced flat or declining growth over the past year, although future growth is anticipated. The company faces challenges in predicting consistent licensing revenue due to its lumpiness and dependency on milestone achievements. Warning! GuruFocus has detected 3 Warning Sign with BOM:530549. Q: Can you provide a breakdown of the biologics segment revenue, specifically how much was contributed by Atalia and the CDMO segment? A: The biologics segment recorded a revenue of 15 to 20 crores from Atalia in the last financial year, which is expected to double in FY26. The rest of the revenue comes from CDMO and licensing, and we can provide exact numbers later. - Executive Director Q: With the official launch of Bozitinib in the US market, can we expect a faster ramp-up in sales compared to Primitex? A: Unlike Primitex, which faced competition from Eagle's product, Bozitinib has no significant competition in the market. We are the only product with subcutaneous approval, which should facilitate a quicker market uptake. - Executive Director Q: Regarding the partnership with Orient for recombinant albumin, what kind of milestone fees can we expect, and is there a delay in starting phase 3 trials? A: Financial details are confidential, but the deal includes milestones spread across signing, filing, approval, and launch. There might be a delay of 1-2 quarters in starting phase 3 trials as we aim to supply from our new facility. - Executive Director Q: Have you received any final inspection dates from the USFDA regarding the import alert, and how will this affect margins? A: We have completed remediation activities, and the FDA is likely to conduct a surprise inspection this financial year. Margin improvement will not be significant from CMO cost savings but will come from increased CDMO revenue and product approvals. - Executive Director Q: Can you explain the significance of the EU GMP approval for the biosimilar plant and its impact on revenue? A: The EU GMP approval is significant as it opens doors for CDMO services in Europe. We expect an increase in CDMO revenue, although the exact impact will depend on the number of contracts secured. - Executive Director For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. 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
