Latest news with #Novartis
Reuters
an hour ago
- Business
- Reuters
Novartis cannot block generic version of Entresto, judge rules
July 16 (Reuters) - A federal judge rejected Novartis' (NOVN.S), opens new tab request for a preliminary injunction to stop MSN Pharmaceuticals from selling a generic version of the blockbuster heart medication Entresto. In a decision on Tuesday, U.S. District Judge Evelyn Padin in Newark, New Jersey also reversed her prior ruling that Novartis would likely succeed on its claim of trade dress infringement against the defendant MSN proposed selling a generic version of Entresto under the name Novadoz, which blends the names of Novartis and its Sandoz generics unit. Padin also said Novartis' exclusivity over Entresto may not continue indefinitely, and that "denial of injunctive relief and the availability of a generic alternative to a life-savings medication is in the public interest." Novartis and its lawyers did not immediately respond to requests for comment on Wednesday. The judge said its patent-related exclusivity expires today, July 16.
Time Business News
2 hours ago
- Health
- Time Business News
Innovative Frontiers in Artemisinin Combination Therapy
To increase efficacy and reduce the risk of drug resistance, artemisinin combination therapy (ACT) treats malaria by mixing an artemisinin-based molecule with one or more fellow drugs. Artemisinin Combination Therapy (ACT) has expanded considerably due to high malaria burden in Southeast Asia and sub-Sahara Africa in the market due to its effectiveness against high malaria burden and drug-resistant Plasmodium Falciparum. Global health initiatives such as WHO guidelines and funding support have improved access and strength. The ongoing drug progress has also increased treatment efficacy and adherence to the patient, collectively increased market growth. Key Growth Drivers and Opportunities Urgent Demand for More Effective Malaria Treatments: A major trend that runs the future of the market is required for more effective malaria remedies between persistent cases and increasing drug resistance. It is promoting innovation in ACT formulations to develop rapid acting, long lasting, and more patient -friendly options. With increased government and international health funding, this progress is improving access and distribution in malaria-sustainable regions, the situation serves as a central solution in the global fight against malaria and promotes strong market development. Challenges Artemisinin combination therapy (ACT) faces boundaries due to the emergence of artemisinin-resistant malaria strains in the market, especially in parts of Southeast Asia. Additionally, inconsistent supply chains, high dependence on donor funding, and limited healthcare infrastructure in some spatial regions obstruct wide access. The need for constant innovation to be ahead of regulator challenges and resistance also leads to the ongoing obstacles for market stability and development. Innovation and Expansion Breakthrough A Treatment for Malaria Without Artemisinin Gives Children Hope In November 2024, Positive findings from KALUMI, a Phase 2 study of a new, non-artemisinin malaria medication combination being developed with Novartis and MMV, have been announced by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM2) consortium. Given that partial resistance to artemisinin derivatives throughout Africa jeopardizes efforts to eradicate the illness, this is a significant advancement in the fight against malaria. The effectiveness and safety of a combination of lumefantrine, reformulated for once-daily dosage, and ganaplacide, a new drug, were assessed in the KALUMI trial. This novel combination was tested against artemether-lumefantrine, the most popular artemisinin-based combination therapy (ACT) for treating uncomplicated malaria in Africa. Fosun Pharma Acquires USD 3.5M to Promote the Development of Malaria Treatments In December 2023, The Japanese Global Health Innovative Technology (GHIT) Fund has awarded Y500m (USD 3.3m) to China-based Fosun Pharma to further the development of a triple artemisinin combination medication for the treatment of malaria. Artemether, lumefantrine, and amodiaquine are the three antimalarial medications that make up the triple artemisinin combination medication, which comes in a fixed dosage format. The money used to support the Phase III research that looks into the combo treatment. Fosun, the Japanese investment firm Marubini, the Thailand-based research partnership of the universities Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV) will all work together to undertake the III trial. Novartis Provides One Billion Antimalarial Treatment Courses Globally In May 2021, Novartis declared that since 1999, it has provided one billion antimalarial therapy sessions. Over 90% of this artemisinin-based combination treatment (ACT) was given to malaria-endemic nations worldwide at no profit. The most lethal kind of malaria, P. falciparum, which accounts for more than 99% of cases in Africa and half of those in Asia, is treated with ACTs as the standard of care2. ACTs have revolutionized the treatment of malaria since the turn of the century and helped to significantly lower the number of malaria-related fatalities. Inventive Sparks, Expanding Markets Among the leading companies for artemisinin combination therapy are Novartis AG, Cipla, Bliss GVS, and KPC Pharmaceuticals, Inc. The artemisinin combination therapy (ACT) firm is focusing on developing more effective and affordable formulations, such as drug-resistant and kid-safe variants, in order to enhance treatment outcomes and accessibility. Working with governments and international health organizations is another important strategy to expand distribution in malaria-endemic areas. To ensure consistent availability, local production and supply linkages are also reinforced. These programs support global efforts to eradicate malaria, combat medication resistance, and improve patient compliance. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
Reuters
20 hours ago
- Business
- Reuters
European second-quarter corporate profits expected to fall 0.7%
July 15 (Reuters) - The outlook for European corporate health has deteriorated, the latest earnings forecasts showed on Tuesday, as U.S. President Donald Trump's most recent tariff statements created further uncertainty for businesses. European companies are expected to report a drop of 0.7% year-on-year in second-quarter earnings, on average, according to LSEG I/B/E/S data, below the 0.2% decrease analysts had expected a week ago. This earnings season is the first to expose the impact of U.S. President Trump's tariff-fueled trade war on corporate health. Trump's tariff policies have changed frequently since April, the most common start of the second fiscal quarter. Some were imposed while others were proposed and then delayed. From last week, consensus for revenue forecasts meanwhile remained the same, with analysts expecting a 3.0% decrease, compared with a 3.0% drop expected before. Last week, after weeks of negotiations, President Donald Trump threatened to impose a 30% tariff on imports from the European Union starting on August 1, though EU ministers have voiced their confidence in still closing a deal before the deadline. The latest estimates compare with a 3.0% increase in earnings and a 0.8% drop in revenues a year ago, the data showed. This would be the worst quarterly performance in more than a year. Second-quarter results from Novartis (NOVN.S), opens new tab and Volvo Cars ( opens new tab expected later this week, might shed more light on how European companies are faring at the start of this reporting quarter. The biggest second-quarter earnings winners are expected to be the Irish and Polish companies in the Europe-wide STOXX 600 stock index, with average growth of 88.6% and 67.3%, respectively. Norwegian and Austrian companies, meanwhile, are expected to see earnings fall 19.4% and 8.2%, respectively. As of Tuesday's close, the STOXX 600 was up about 7.4% year to date.
Globe and Mail
a day ago
- Business
- Globe and Mail
Will Key Drugs Maintain Momentum for Novartis in Q2 Earnings?
Novartis AG NVS, a Swiss pharma giant, is scheduled to report second-quarter 2025 results on July 17. The Zacks Consensus Estimate for revenues is pegged at $14.04 billion, while the same for earnings is pinned at $2.38 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) NVS' Earnings Surprise History Novartis has an excellent track record. Its earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 7.12%. In the previously reported quarter, earnings beat estimates by 7.55%. What Our Model Predicts for NVS Our proven model does not conclusively predict an earnings beat for Novartis this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. Earnings ESP: Earnings ESP for NVS is -0.28% as the Zacks Consensus Estimate is pegged at $2.38 per share, while the Most Accurate Estimate is pinned at $2.37. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Zacks Rank: The company currently carries a Zacks Rank #2. Factors Driving Growth for NVS in Q2 Novartis operates as a single global operating segment after the successful spin-off of the Sandoz business in October 2023. NVS now concentrates on four core therapeutic areas — cardiovascular-renal-metabolic, immunology, neuroscience and oncology. NVS' second-quarter sales are likely to have been boosted by strong growth in Entresto, Kisqali, Kesimpta, Leqvio and Scemblix. Cardiovascular drug Entresto sales witnessed a solid year-over-year surge in the first quarter of 2025, driven by robust demand-led growth. Increased penetration in China and Japan for hypertension indication also boosted demand. The momentum is likely to have continued in the second quarter. The Zacks Consensus Estimate and our model estimate for Entresto's second-quarter sales are pegged at $2.3 billion and $2.2 billion, respectively. The stellar performance of the breast cancer drug Kisqali has likely fueled the top line in the second quarter as well. Strong momentum from the recently launched early breast cancer (eBC) indication in the United States has likely propelled sales further. Overall demand for the drug is being driven by increasing recognition of its overall survival benefit in HR+/HER2- metastatic breast cancer (mBC) as well as Category 1 NCCN Guidelines recommendation in both mBC and eBC. The Zacks Consensus Estimate and our model estimate for Kisqali's second-quarter sales are pegged at $1 billion and $1.1 billion, respectively. Increased demand has likely fueled multiple sclerosis drug Kesimpta's sales in the to-be-reported quarter. Both the Zacks Consensus Estimate and our model estimate for Kesimpta's second-quarter sales are pegged at $1 billion. Cosentyx's sales have also likely surged in the United States, emerging growth markets and Europe, driven by recent launches as well as volume growth in core indications. The Zacks Consensus Estimate and our model estimate for Cosentyx's second-quarter sales are pegged at $1.73 billion and $1.77 billion, respectively. Strong growth in cholesterol-lowering drug Leqvio, too, has likely fueled sales in the second quarter. The Zacks Consensus Estimate and our model estimate for Leqvio's second-quarter sales are pegged at $284 million and $282 million, respectively. Pluvicto continues to maintain momentum with continued stable performance in the country and Europe in the metastatic castration-resistant prostate cancer post-taxane setting. The FDA approved the drug for use before chemotherapy. This approval approximately triples the eligible patient population. Consequently, Novartis is now focusing on driving demand in established RLT sites while activating new sites and supporting referring providers to enable patient access. The Zacks Consensus Estimate and our model estimate for Pluvicto's second-quarter sales are pegged at $410 million and $411 million, respectively. Demand for Scemblix for the indication of chronic myeloid leukemia (CML) continued to grow in the previous quarter, driven by high unmet need in CML along with strong momentum from the recently launched early-line indication in the United States. The trend likely continued into the second quarter as well. Other growth drivers, such as Zolgensma, Lutathera, Jakavi and Tafinlar + Mekinist, have likely witnessed an increase in demand. However, generic competition for Tasigna and Lucentis might have affected sales, as in the previous quarters. Key Recent Events In June 2025, Novartis acquired clinical-stage biopharmaceutical company Regulus Therapeutics Inc. for an upfront payment of $0.8 billion. It may receive an additional $0.9 billion upon attaining a future regulatory milestone. The acquisition added lead asset farabursen to NVS' pipeline. Farabursen is a novel, next-generation oligonucleotide targeting miR-17, which is being evaluated for autosomal dominant polycystic kidney disease. NVS' Price Performance Shares of Novartis have rallied 27.3% year to date compared with the industry 's 1.8% growth. Stocks to Consider Here are some drug/biotech stocks that have the right combination of elements to beat on earnings this time around: Bayer BAYRY has an Earnings ESP of +6.38% and a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank stocks here. BAYRY beat on earnings in one of the trailing four quarters, met in two and missed in the remaining one, the average negative surprise being 13.91%. Bayer will report second-quarter results on Aug. 6, 2025. Exelixis EXEL has an Earnings ESP of +4.27% and a Zacks Rank #2 at present. Exelixis beat on earnings in each of the trailing four quarters, the average surprise being 48.6%. EXEL will report second-quarter results on July 28, 2025. Gilead Sciences, Inc. GILD has an Earnings ESP of +2.13% and a Zacks Rank of 2 at present. GILD beat on earnings in three of the trailing four quarters and missed in the remaining one, delivering an average surprise of 16.48%. Shares of GILD have gained 23.1% year to date. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.5% per year. So be sure to give these hand picked 7 your immediate attention. See them now >> 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 Novartis AG (NVS): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report Exelixis, Inc. (EXEL): Free Stock Analysis Report
Globe and Mail
2 days ago
- Business
- Globe and Mail
Multiple Sclerosis Pipeline Landscape Appears Robust With 75+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Multiple Sclerosis Pipeline Insight 2025' report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Multiple sclerosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Multiple Sclerosis Treatment Landscape. Click here to read more @ Multiple Sclerosis Pipeline Outlook Key Takeaways from the Multiple Sclerosis Pipeline Report In July 2025, Novartis Pharmaceuticals announced a study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. In July 2025, Sanofi conducted a study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. DelveInsight's Multiple Sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for Multiple Sclerosis treatment. The leading Multiple Sclerosis Companies such as Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others. Promising Multiple Sclerosis Therapies such as 11C-BMS-986196, ofatumumab, Fingolimod, Siponimod, elezanumab, Alemtuzumab, Tecfidera, and others. Stay informed about the cutting-edge advancements in Multiple Sclerosis treatments. Download for updates and be a part of the revolution in cancer care @ Multiple Sclerosis Clinical Trials Assessment Multiple sclerosis Emerging Drugs Profile IMU-838: Immunic Therapeutics Vidofludimus calcium (IMU-838) is a small molecule investigational drug under development as an oral tablet formulation for the treatment of relapsing-remitting multiple sclerosis, or RRMS, inflammatory bowel disease, or IBD, and other chronic inflammatory and autoimmune diseases. Bolstered by excellent clinical data from the phase II EMPhASIS trial, Immunic believed that vidofludimus calcium has the potential to demonstrate medically important advantages compared with other treatments, particularly for the early treatment of RMS patients, due to its placebo like safety profile and its robust anti-inflammatory and neuroprotective properties. BIIB091: Biogen BIIB091 selectively inhibits Burton's tyrosine kinase (BTK), a non-receptor tyrosine kinase that regulates the development and signaling of B cells and myeloid cells hypothesized to contribute to MS pathogenesis. In addition, BTK has been demonstrated to play a key role in the activation of another cell of the immune system, the myeloid cells via another receptor of this cell (Fcγ receptor signaling (FcγRs)). Preclinical studies demonstrated BIB091 to be a high potency molecule with good drug-like properties and a safety/tolerability profile suitable for clinical development as a highly selective, reversible BTKi for treating autoimmune diseases such as MS. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple sclerosis. IMCY-0141: ImCyse IMCY-0141 is the Company's second clinical-stage compound. This Imotope is designed based on MOG (Myelin Oligodendrocyte Glycoprotein) with the aim to halt the progression of multiple sclerosis (MS) by stopping the body's immune system from attacking the central nervous system and disrupting undesirable autoimmune responses that drive the destruction of the myelin sheath protecting the nerves. IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action and inducing a memory response so that the treatment effect is long-lasting and requires less frequent dosing regimens. Also, if treatment is begun early enough, it has the potential to allow patients to live with minimal impact from the disease. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of multiple sclerosis. NeuroVax: Immune Response BioPharma NeuroVax contains a combination of three protein fragments (peptides) which appear on the surface of T-cells involved in the immune response in MS. Studies suggested that treatment with NeuroVax stimulates production of certain regulatory T-cells, which in turn decrease the levels of other T-cells which attack myelin. NeuroVax is a Once a Month Dosing injection, safe, tolerable, enhances FOXP3+ Tregs & Regulates Pathogenic T Cells in MS Patients, a first in class disease modifying Multiple Sclerosis Vaccine. NeuroVax IR has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax appears to work in part by enhancing levels of Foxp3+ Tregs, which may help regulate expression of pathogenic T cells in MS patients. The three TCR peptides combined in it correspond to one or more TCR gene families which are over expressed in 90% of MS patients. The Multiple Sclerosis Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Multiple Sclerosis with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Multiple Sclerosis Treatment. Multiple Sclerosis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Multiple Sclerosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different Multiple Sclerosis mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Multiple Sclerosis market Learn more about Multiple Sclerosis Drugs opportunities in our groundbreaking Multiple Sclerosis research and development projects @ Multiple Sclerosis Unmet Needs Multiple Sclerosis Companies Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others. Multiple sclerosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Multiple Sclerosis Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Discover the latest advancements in Multiple Sclerosis treatment by visiting our website. Stay informed about how we're transforming the future of neurology @ Multiple Sclerosis Market Drivers and Barriers, and Future Perspectives Scope of the Multiple Sclerosis Pipeline Report Coverage- Global Multiple Sclerosis Companies- Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others. Multiple Sclerosis Therapies- 11C-BMS-986196, ofatumumab, Fingolimod, Siponimod, elezanumab, Alemtuzumab, Tecfidera, and others. Multiple Sclerosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Multiple Sclerosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of Multiple Sclerosis Pipeline on our website @ Multiple Sclerosis Emerging Drugs and Companies Table of Content Introduction Executive Summary Multiple sclerosis: Overview Pipeline Therapeutics Therapeutic Assessment Multiple sclerosis – DelveInsight's Analytical Perspective Late Stage Products (Phase III) IMU-838: Immunic Therapeutics Drug profiles in the detailed report….. Mid Stage Products (Phase II) BIIB091: Biogen Drug profiles in the detailed report….. Early Stage Products (Phase I) NeuroVax: Immune Response BioPharma Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Multiple sclerosis Key Companies Multiple sclerosis Key Products Multiple sclerosis- Unmet Needs Multiple sclerosis- Market Drivers and Barriers Multiple sclerosis- Future Perspectives and Conclusion Multiple sclerosis Analyst Views Multiple sclerosis Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. 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