Latest news with #ZydusLifesciences
Time of India
5 days ago
- Business
- Time of India
Zydus moves Delhi HC against order restraining sale of its cancer drug
Zydus Lifesciences on Thursday moved the division bench of the Delhi High Court against its single judge's earlier order that temporarily restrained the Ahmedabad-based drug maker from manufacturing, selling biosimilar of US pharma giant E.R. Squibb's patent Nivolumab , a therapeutic antibody used in the treatment of cancer. The Division Bench while refusing to stay the single judge's interim order sought response from the US pharma company, which had alleged patent infringement of its blockbuster anticancer drug Opdyta (nivolumab) branded as Opdivo in other countries. In India, Nivolumab is being imported and marketed as Opdyta. Explore courses from Top Institutes in Please select course: Select a Course Category PGDM Technology Digital Marketing Data Science Others Management Cybersecurity Healthcare Data Science Product Management Public Policy MBA others Design Thinking Finance Leadership Project Management CXO MCA Data Analytics Artificial Intelligence Operations Management healthcare Degree Skills you'll gain: Financial Analysis & Decision Making Quantitative & Analytical Skills Organizational Management & Leadership Innovation & Entrepreneurship Duration: 24 Months IMI Delhi Post Graduate Diploma in Management (Online) Starts on Sep 1, 2024 Get Details While Squibb alleged that Zydus was conducting clinical trials for nivolumab and had plans to launch it during is valid patent period, the Indian company denied the allegations, saying its product ZRC-3276 does not infringe upon the existing patents, was following the regulatory provisions and had applied for a marketing approval with the central drug regulatory agency. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Simoes Filho: Unsold Furniture Liquidation 2024 (Prices May Surprise You) Unsold Furniture | Search Ads Learn More Undo Zydus argued that its product, ZRC-3276, is bio-similar to Squibb Nivolumab, but bio-similarity by itself does not substantiate infringement as it is based upon product-to-product comparison, whereas, infringement required claim to product mapping. The generic drug maker claimed that process steps were already known from the prior art and even several techniques for the preparation of human anti-PD1 antibodies were well-known on the priority date of the suit patent. Live Events The post-grant opposition that was filed by its subsidiary Zydus Healthcare led to the recommendation for revocation of the suit patent by the Opposition Board, and the said recommendation clearly showed that such a method was commonly employed to produce antibodies, the Ahmedabad-based drug manufacturer claimed. On July 18, Justice Mini Pushkarna had noted that E.R. Squibb shall suffer irreparable loss in case an interim relief was not granted. Therefore, the single judge had restrained Zydus from selling a biosimilar of Nivolumab till the main suit was decided.
Business Standard
5 days ago
- Business
- Business Standard
Zydus receives USFDA tentative approval for Ibrutinib tablets
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica tablets, 140 mg, 280 mg and 420 mg). Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion, and Waldenstrom's macroglobulinemia (WM). Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Ibrutinib tablets had annual sales of USD 2148.9 mn in the United States (IQVIA MAT May 2025). The group now has 420 approvals and has so far filed 484 ANDAs since the commencement of the filing process in FY 2003-04.
Business Standard
5 days ago
- Business
- Business Standard
Zydus Lifesciences gets USFDA Nod for Ibrutinib tablets
Zydus Lifesciences informed that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg. Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) with a 17p deletion, and Waldenstr's macroglobulinemia (WM). Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. The tablets had annual sales of $2,148.9 million in the United States (IQVIA MAT May 2025). The group now holds 420 approvals and has filed a total of 484 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. Shares of Zydus Lifesciences rose 0.78% to currently trade at Rs 969.15 on the BSE.
Business Upturn
5 days ago
- Business
- Business Upturn
Zydus Lifesciences gets tentative approval from USFDA for Ibrutinib tablets
Zydus Lifesciences has received tentative approval from the USFDA to market Ibrutinib tablets in the 140 mg, 280 mg, and 420 mg strengths in the U.S. market. The drug is a generic version of Imbruvica® and is used in treating adult patients with Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion, as well as Waldenstrom's Macroglobulinemia (WM). The tablets will be manufactured at Zydus' SEZ facility in Ahmedabad. According to IQVIA (MAT May 2025), Ibrutinib tablets clocked annual sales of USD 2.15 billion in the U.S. With this, Zydus now holds 420 approvals and has filed 484 ANDAs since it began filings in FY 2003-04. In the meantime, Zydus Lifesciences shares opened today at ₹962.95 and, at the time of writing, touched a high of ₹976.60 during the session. The stock also hit a low of ₹960.15 in intraday trade. Over the past year, Zydus shares have seen a 52-week high of ₹1,324.30 and a low of ₹795.00. Ahmedabad Plane Crash 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
Mint
7 days ago
- Business
- Mint
Dividend stocks: LIC, Hero MotoCorp to Lupin — these shares to trade ex-date soon
A host of dividend-paying stocks are set to trade ex-dividend in the coming week, offering potential opportunities for income-focused investors. According to data available on the BSE, notable names like Life Insurance Corporation of India (LIC), Hero MotoCorp, Lupin, Zydus Lifesciences, and Pidilite Industries, among others, have declared dividend record dates between July 23 and July 25, 2025. The ex-dividend date is the cut-off date on which a stock starts trading without the value of its upcoming dividend. Investors holding the stock before this date are eligible to receive the declared dividend. Those who buy the stock on or after the ex-dividend date will not be entitled to the payout. To be eligible, investors must be on the company's books by the record date, which usually falls one working day after the ex-date. India's largest insurer, LIC, has declared an interim dividend of ₹ 12 per share for FY25. The record date is July 25, 2025. All shareholders whose names appear on LIC's register by the end of that date will be eligible to receive the dividend. The company has informed exchanges that, if approved, the dividend will be paid around September 25. Pharma major Lupin recommended a final dividend of ₹ 12 per equity share (face value: ₹ 2), translating into a 600% payout for FY25. The dividend is subject to shareholder approval at the upcoming AGM, and the record date has been fixed for July 25, 2025. The two-wheeler giant's board proposed a final dividend of ₹ 65 per share (face value: ₹ 2) during its meeting on May 13, 2025. The record date is July 24, and the dividend will be approved at the company's 42nd Annual General Meeting. Pidilite, known for its Fevicol brand, has announced a dividend of ₹ 20 per share (face value: ₹ 1), with a record date of July 23. This payout will also be subject to shareholder approval at the AGM. At its meeting on May 17, Divi's board proposed a final dividend of ₹ 30 per share (face value: ₹ 2) for FY25. The company has set July 25, 2025 as the record date for eligibility. Several other companies are also set to trade ex-dividend next week: Zydus Lifesciences: ₹ 11 per share (record date: July 25) Info Edge: ₹ 3.6 per share (record date: July 25) Union Bank of India: ₹ 4.75 per share (record date: July 25) Cholamandalam Investment and Finance: ₹ 0.70 per share (record date: July 24) Dividend season continues to offer attractive income opportunities across sectors. Investors planning to capitalise on these payouts should track record and ex-dividend dates closely to ensure eligibility. As always, experts advise factoring in the overall financial performance and dividend sustainability of companies, especially in volatile markets, before making fresh investment decisions based purely on dividend announcments. Disclaimer: The views and recommendations made above are those of individual analysts or broking companies, and not of Mint. We advise investors to check with certified experts before making any investment decisions.
