Latest news with #EYLEA®
Business Upturn
a day ago
- Business
- Business Upturn
Biocon subsidiary gets Health Canada nod for YESAFILI
By Aman Shukla Published on June 27, 2025, 09:19 IST Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has received a Notice of Compliance from Health Canada for YESAFILI™ (aflibercept), marking a significant milestone in the company's global biosimilars journey. The regulatory approval, granted on June 26, 2025, makes YESAFILI the first biosimilar to EYLEA® (aflibercept) to be approved in Canada. The product will be available in both vial and prefilled syringe forms (2 mg/0.05 mL), with its commercial launch set for July 4, 2025. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor designed to treat several serious eye conditions. These include neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema caused by retinal vein occlusion (CRVO and BRVO), as well as myopic choroidal neovascularization (myopic CNV). The approval is backed by a robust data package encompassing analytical, nonclinical, and clinical studies. Health Canada concluded that YESAFILI matches EYLEA in quality, safety, and effectiveness, with no clinically meaningful differences. This milestone not only reinforces Biocon Biologics' capabilities in developing high-quality biosimilars but also enhances patient access to affordable treatment options in Canada. 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
Associated Press
27-02-2025
- Business
- Associated Press
REGN DEADLINE ALERT: Regeneron Pharmaceuticals (REGN) Investors with Losses Encouraged to Contact Hagens Berman Before Mar. 10th Deadline in Securities Class Action
SAN FRANCISCO, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) is facing headwinds on multiple fronts, including disappointing sales figures, ongoing legal challenges, and analyst downgrades. TD Cowen recently lowered its price target for Regeneron to $1,030 from $1,230, citing increased competition and lower revenue estimates for EYLEA®, a key product. The firm pointed to preannounced January figures for the drug's sales. This downgrade compounds existing woes. Regeneron is also embroiled in a securities fraud class action lawsuit stemming from a significant stock price drop on October 31, 2024. Shares plunged $84.59 that day, wiping out approximately $9 billion in market capitalization. Hagens Berman is probing the allegations and urges investors who purchased Regeneron shares and suffered substantial losses to submit your losses now. Class Period: Nov. 2, 2023 – Oct. 30, 2024 Lead Plaintiff Deadline: Mar. 10, 2025 Visit: 844-916-0895 Regeneron Pharmaceuticals, Inc. (REGN) Securities Class Action: The litigation centers around Regeneron's disclosures regarding Medicare reimbursement rules for EYLEA®. The lawsuit alleges the company made false and misleading statements and failed to disclose that it paid credit card fees to distributors on the condition they wouldn't pass those fees on to EYLEA® customers. These payments effectively subsidized EYLEA® purchases made with credit cards, constituting undisclosed price concessions that allegedly inflated reported sales figures. The suit claims these undisclosed concessions gave Regeneron a competitive advantage, as retina practices are sensitive to price fluctuations for anti-VEGF medications purchased via credit card. It further alleges that by not reporting these payments as price concessions, Regeneron overstated the Average Sales Price (ASP) reported to federal agencies, a potential violation of the False Claims Act. The investor class action suit alleges the truth began to emerge on April 10, 2024, when the Department of Justice (DOJ) sued Regeneron for False Claims Act violations. The DOJ lawsuit alleged Regeneron fraudulently inflated Medicare reimbursement rates for EYLEA® by submitting false ASP reports to the Centers for Medicare & Medicaid Services (CMS). The DOJ alleges these reports failed to account for the price concessions provided through credit card processing fees, and that Regeneron used the stable ASP and resulting stable reimbursement as a competitive advantage. The October 31, 2024, stock drop occurred after Regeneron released Q3 2024 results, revealing disappointing U.S. net sales for EYLEA® and EYLEA HD®. The company reported only a 3% sales increase year-over-year, attributing the lackluster performance to 'the lower net selling price compared to the third quarter of 2023" and 'anti-VEGF category pricing pressure.' This news sent Regeneron shares down over 9% that day. Hagens Berman is looking into whether Regeneron betrayed investor trust by misrepresenting the legitimacy of its revenue reporting. 'The precipitous stock decline, coupled with emerging details surrounding Eylea sales, raises questions about the propriety of Regeneron's disclosures and adherence to regulatory standards,' stated Reed Kathrein, the Hagens Berman partner heading the inquiry. 'Our investigation is focused on determining whether the company's conduct amounts to securities fraud.' If you invested in Regeneron and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the Regeneron case and our investigation, read more » Whistleblowers: Persons with non-public information regarding Regeneron should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. Contact: Reed Kathrein, 844-916-0895
Associated Press
14-02-2025
- Business
- Associated Press
Analyst Cuts Regeneron Pharmaceuticals (REGN) Price Target After Sales Concerns and Investor Lawsuit– Hagens Berman
SAN FRANCISCO, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is facing mounting pressure on multiple fronts. Following disappointing sales figures and ongoing legal challenges, analysts TD Cowen recently lowered its price target for Regeneron to $1,030 from $1,230. The downward revision reflects preannounced January figures for EYLEA®, a key product in Regeneron's portfolio, with TD Cowen citing increased competition in the market and significantly lowering its revenue estimates for the EYLEA® franchise. This price target reduction adds to the company's existing woes. Regeneron is also embroiled in a securities fraud class action lawsuit following a significant drop in its stock price on October 31, 2024. Shares plunged $84.59 that day, erasing approximately $9 billion from the company's market capitalization. Hagens Berman has opened an investigation into the allegations and urges investors who purchased Regeneron shares and suffered substantial losses to submit your losses now. Class Period: Nov. 2, 2023 – Oct. 30, 2024 Lead Plaintiff Deadline: Mar. 10, 2025 Visit: 844-916-0895 Regeneron Pharmaceuticals, Inc. (REGN) Securities Class Action: The litigation centers around Regeneron's disclosures regarding its compliance with Medicare reimbursement rules and regulations, specifically concerning its EYLEA® product. The lawsuit alleges that Regeneron made false and misleading statements and failed to disclose several key facts: Regeneron allegedly paid credit card fees to distributors on the condition that these distributors would not pass on those fees to EYLEA® customers. These payments effectively subsidized the prices customers paid when using credit cards to purchase EYLEA®. Consequently, Regeneron allegedly offered undisclosed price concessions, lowering the actual selling price of EYLEA®. Because retina practices are sensitive to price fluctuations when using credit cards for anti-VEGF medications, these undisclosed price concessions provided Regeneron with a competitive advantage. As a result of the above, Regeneron allegedly inflated its reported EYLEA® sales figures. By not reporting these credit card fee payments as price concessions, Regeneron allegedly overstated the Average Sales Price (ASP) reported to federal agencies, which constitutes a violation of the False Claims Act. This lawsuit follows an April 10, 2024, announcement by the Department of Justice (DOJ) that it had also sued Regeneron for False Claims Act violations. The DOJ's lawsuit makes similar allegations, claiming that Regeneron fraudulently inflated Medicare reimbursement rates for EYLEA® by submitting false reports to the Centers for Medicare and Medicaid Services (CMS). These false reports, according to the DOJ, were based on ASP calculations that failed to account for the price concessions provided through the credit card processing fees. The DOJ further alleges that Regeneron used the stable ASP (and resulting stable reimbursement) of EYLEA® as a competitive advantage when marketing to retina practices, emphasizing it against competitors. The October 31, 2024, stock drop occurred after Regeneron released its Q3 2024 financial results, which revealed disappointing U.S. net sales for EYLEA® and EYLEA HD®. The company reported only a 3% sales increase compared to the same period in the previous year, attributing the lackluster performance to 'the lower net selling price compared to the third quarter of 2023" and 'anti-VEGF category pricing pressure.' This news drove the price of Regeneron shares down over 9% that day. Hagen Berman is investigating whether Regeneron intentionally misled investors about the legality of its reported revenues. 'The significant stock drop and subsequent revelations regarding Eylea sales raise serious questions about Regeneron's transparency and compliance,' said Reed Kathrein, the Hagens Berman partner leading the firm's investigation. 'We are investigating whether the company's actions constitute securities fraud.' If you invested in Regeneron and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the Regeneron case and our investigation, read more » Whistleblowers: Persons with non-public information regarding Regeneron should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. Contact:
