Latest news with #HIV-1
Yahoo
5 days ago
- Business
- Yahoo
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030.1 "Xpert® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578https:// About CepheidBased in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit IVD. In Vitro Diagnostic Medical Device. May not be available in all countries For Cepheid Media Inquiries:Darwa SOURCE Cepheid View original content to download multimedia: Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Cision Canada
5 days ago
- Business
- Cision Canada
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert ® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert ® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030. 1 "Xpert ® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert ® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert ® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578 About Cepheid Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit
Yahoo
5 days ago
- Business
- Yahoo
Cepheid Receives Health Canada Licence for Xpert® HIV-1 Viral Load XC
Next-Generation Molecular Test for Monitoring Viral Load and HIV-1 Infection SUNNYVALE, Calif., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment. Xpert® HIV-1 Viral Load XC dual target test provides extended strain coverage ensuring a high level of performance with a simple workflow to improve patient access to the standard of care and help achieve UNAIDS HIV targets by 2030.1 "Xpert® HIV-1 Viral Load XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Vitor Rocha, President of Cepheid. "Access to the test can enhance patient care, as measurement of HIV viral load informs treatment plans while fast results enable earlier interventions with counseling and therapy." The test is designed for use on any of Cepheid's GeneXpert® Systems which provide simple, reference lab quality PCR testing on location in laboratory environments at medical centers and hospitals or in community health clinics and physician offices. Xpert® HIV-1 Viral Load XC will begin shipping to customers in Canada in June 2025. Visit for more information. Malisa et al 2023 Nature Scientifc Reports | (2023) 13:4578https:// About CepheidBased in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit IVD. In Vitro Diagnostic Medical Device. May not be available in all countries For Cepheid Media Inquiries:Darwa SOURCE Cepheid View original content to download multimedia:
Yahoo
20-05-2025
- Business
- Yahoo
Gilead Sciences vs GSK: Which HIV Drugmaker is a Smarter Buy Now?
Gilead Sciences, Inc. GILD and GSK GSK are pioneers in the human immunodeficiency virus (HIV) treatment space. Gilead Sciences is a dominant player in the HIV market with market-leading treatments. HIV drug sales accounted for 69% of total product sales in the first quarter of 2025. GILD's diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases. GSK, too, has a strong HIV portfolio in the industry. HIV drug sales accounted for 23% of total sales in the first quarter. GSK also has a strong foothold in respiratory, oncology and other therapeutic areas, along with a robust portfolio of vaccines. Both these biotech giants have delivered consistent returns to shareholders on the back of strong sales and earnings momentum. In such a scenario, choosing one stock over another can be challenging. Let us delve into their fundamentals, potential growth prospects, challenges and valuation levels to make a prudent choice. Gilead is a dominant player in the HIV market. The company's flagship drug, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF), for HIV-1 infection has become the number-one prescribed regimen for both treatment-naïve and switch patients. Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum for GILD in the upcoming quarters. Descovy (FTC 200 mg/TAF 25 mg) for pre-exposure prophylaxis (PrEP) is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States. Gilead's efforts to innovate its HIV portfolio are impressive. Late-stage studies, PURPOSE 1 and PURPOSE 2, validated lenacapavir's potential to prevent HIV. The FDA accepted new drug application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a target action date of June 19, 2025. The European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention. The successful development and potential approval of lenacapavir for the prevention of the disease should solidify Gilead's HIV franchise. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a larger number of people who could benefit from a prevention regimen. Separately, Gilead's oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. The breast cancer drug Trodelvy has performed well since its approval. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025. The Liver Disease portfolio includes treatments for HCV, chronic hepatitis B virus (HBV) and chronic hepatitis delta virus (HDV). Gilead is making efforts to expand this franchise further. The recent FDA approval of seladelpar, under the brand name Livdelzi, for the treatment of primary biliary cholangitis has strengthened the liver disease portfolio. As of March 31, 2025, Gilead's total debt-to-total-capital ratio was 56.7%. It had $7.9 billion in cash, cash equivalents, and marketable debt securities, and $22.1 billion in long-term debt at the end of the first quarter. GSK's HIV portfolio sales are being driven by strong patient demand of Cabenuva, Apretude and Dovato. The company is focused on the next generation of HIV innovation with integrase inhibitors (INSTIs) — for HIV treatment and prevention. Cabenuva, the only complete long-acting injectable regimen for HIV treatment, is witnessing strong patient demand across the United States and Europe. Dovato, the first and only once-daily Oral two-drug-regimen (2DR) for the treatment of HIV infection in both treatment naive and virally suppressed adults and adolescents continues to be the largest product in the HIV portfolio. Apretude, the first long-acting injectable option for HIV prevention is witnessing encouraging traction. GSK currently has three new INSTIs in development and five planned launches. These should continue to drive performance in the coming decade. Apart from this, GSK's diverse portfolio comprises drugs for oncology, respiratory and immunology, along with a wide portfolio of vaccines for meningitis, flu and others. Key drug Nucala has witnessed stupendous success. New oncology drugs Jemperli and Ojjaara are witnessing strong patient demand and contributing to top-line growth. Recent approvals of Jesduvroq/ Duvroq (daprodustat) for anemia due to chronic kidney disease (CKD) in adults on dialysis in the United States, Arexvy, its RSV vaccine for older adults in the United States and Europe, and Ojjaara (momelotinib) for myelofibrosis with anemia in the United States should drive growth. Penmenvy, GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating, uncomplicated urinary tract infection were approved in the United States in the first quarter of 2025. GSK is also working on expanding the label of marketed products into additional indications. However, a challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. As of March 31, 2025, GSK's net debt (short term+long term) was $23.2 billion. The cash/liquid investments were around $5.8 billion, higher than the short-term debt of $2.5 billion. The debt/capital ratio of 57.4% at the end of March 2025 was higher than 56.5% at the end of December 2024. The Zacks Consensus Estimate for GILD's 2025 sales implies a year-over-year decrease of 0.84%, and that for earnings per share (EPS) suggests a year-over-year improvement of 71.21%. EPS estimates for both 2025 and 2026 have moved north in the past 60 days. Image Source: Zacks Investment Research The Zacks Consensus Estimate for GSK's 2025 sales implies a year-over-year increase of 6.2% while that for EPS suggests a year-over-year improvement of 6.17%. EPS estimates for both 2025 and 2026 have moved north in the past 60 days. Image Source: Zacks Investment Research From a price-performance perspective, GILD has fetched better returns than GSK so far this year. Shares of GILD have gained 15.7%, while those of GSK have risen 14.7%. The industry has declined 6.2% in the said period. Image Source: Zacks Investment Research From a valuation standpoint, GILD is more expensive than GSK. GILD's shares currently trade at 13.11X forward earnings, higher than 8.44 for GSK. Image Source: Zacks Investment Research GILD and GSK's attractive dividend yield is a strong positive for investors. However, GSK's dividend yield of 4.48% is higher than GILD's 3.08%. Large biotech companies are generally considered safe havens for investors interested in this sector. Both GILD and GSK are stalwarts in the volatile dynamic biotech industry. Gilead's efforts to constantly innovate its HIV portfolio should enable it to maintain growth. A strong catalyst for the stock going forward is a potential approval of lenacapavir for HIV prevention (target action date in June 2025). However, GILD's HIV portfolio, which accounts for lion's share of its total revenues, is likely to be under pressure due to the new Medicare Part D model and the oncology business facing headwinds. GILD has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. GSK also enjoys a strong position in the HIV market. It is witnessing increased sales growth, reflecting successful new launches in oncology and long-acting HIV medicines. GSK has some promising new cancer drugs, namely Ojjaara and Jemperli, in its portfolio. Potential label expansion of key drugs should bolster growth. With a Zacks Rank #2 (Buy) at present, we believe GSK is a better pick at current valuation levels, given its wide and diverse portfolio, upcoming product launches, promising pipeline candidates and recent positive estimate revisions. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Business Standard
08-05-2025
- Business
- Business Standard
Lupin gets USFDA nod for Raltegravir tablets
Lupin announced that it has received an approval from US Food and Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg. Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg, of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins Nagpur facility in India. Raltegravir Tablets USP, 600 mg, are indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients and pediatric patients weighing at least 40 kg. Raltegravir Tablets USP, 600 mg (Reference Listed Drug: Isentress HD), had estimated annual sales of $34 million in the U.S. for the 12 months ending March 2025, according to IQVIA. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025. The scrip fell 3.12% to end at Rs 2,006.40 on the BSE.
